title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 23.11.2017

               on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
                  1
               , and in particular Articles 39(10) and 42(13) thereof,

               Having regard to Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
                  2
               , and in particular Articles 35(10) and 38(13) thereof,

               Whereas:

               (1)Conformity assessment of medical devices under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 may require involvement of conformity assessment bodies. Only conformity assessment bodies that have been designated under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 may carry out such assessment and only for the activities related to the types of devices concerned. In order to enable specifying the scope of the designation of conformity assessment bodies notified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 it is necessary to draw up list of codes and corresponding types of devices.

               (2)The lists of codes and corresponding types of devices should take into account various device types which can be characterised by design and intended purpose, manufacturing processes and technologies used, such as sterilisation and the use of nanomaterials. The lists of codes should provide for a multi-dimensional typology of devices which ensures that conformity assessment bodies designated as notified bodies are fully competent for the devices they are required to assess.

               (3)In accordance with Article 42(3) of Regulation (EU) 2017/745 and Article 38(3) of Regulation (EU) 2017/746, when notifying the Commission and the other Member States of the conformity assessment bodies they have designated Member States are to clearly specify, using the codes, the scope of the designation indicating the conformity assessment activities and the types of devices which the notified body is authorised to assess. In order to facilitate such notification and the assessment of the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746, conformity assessment bodies should use the lists of codes and corresponding types of devices set out in this Regulation when applying for designation.

               (4)Experience shows that conformity assessment bodies applying for designation in the field of in vitro diagnostic medical devices also apply for designation for medical devices under Regulation (EU) 2017/745. It is therefore appropriate, for reasons of user-friendliness, to include the lists of codes for Regulation (EU) 2017/745 and for Regulation (EU) 2017/746 in one Implementing Regulation.

               (5)As of 26 November 2017, conformity assessment bodies may submit an application for designation as a notified body under Regulation (EU) 2017/745 and Regulation (EU) 2017/746. In order to enable the conformity assessment bodies to use the codes laid down in this Regulation in the application for designation, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

               (6)The measures provided for in this Regulation are in accordance with the opinion of the Committee on Medical Devices,

               HAS ADOPTED THIS REGULATION:

               Article 1

               List of codes

               1.
                     The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 is set out in Annex I to this Regulation.

               2.
                     The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 is set out in Annex II to this Regulation.

               Article 2

               Application for designation

               Conformity assessment bodies shall use the lists of codes and corresponding types of devices set out in Annexes I and II to this Regulation when specifying the types of devices in the application for designation referred to in Article 38 of Regulation (EU) 2017/745 and Article 34 of Regulation (EU) 2017/746.

               Article 3

               Entry into force

               This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 23.11.2017

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 117, 5.5.2017, p.1.

                     (2)

                        OJ L 117, 5.5.2017, p.176.

    ---documentbreak---

               ANNEX I

               The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745

               ICODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

               A)Active devices

               (1)Active implantable devices

                        MDA CODE

                        Active implantable devices

                        MDA 0101

                        Active implantable devices for stimulation / inhibition / monitoring

                        MDA 0102

                        Active implantable devices delivering drugs or other substances

                        MDA 0103

                        Active implantable devices supporting or replacing organ functions

                        MDA 0104

                        Active implantable devices utilising radiation and other active implantable devices

               (2)Active non-implantable devices for imaging, monitoring and/or diagnosis

                        MDA CODE

                        Active non-implantable devices for imaging, monitoring and/or diagnosis

                        MDA 0201

                        Active non-implantable imaging devices utilising ionizing radiation

                        MDA 0202

                        Active non-implantable imaging devices utilising non-ionizing radiation

                        MDA 0203

                        Active non-implantable devices for monitoring of vital physiological parameters

                        MDA 0204

                        Other active non-implantable devices for monitoring and/or diagnosis

               (3)Active non-implantable therapeutic devices and general active non-implantable devices

                        MDA CODE

                        Active non-implantable therapeutic devices and general active non-implantable devices

                        MDA 0301

                        Active non-implantable devices utilising ionizing radiation

                        MDA 0302

                        Active non-implantable devices utilising non-ionizing radiation

                        MDA 0303

                        Active non-implantable devices utilising hyperthermia / hypothermia

                        MDA 0304

                        Active non-implantable devices for shock-wave therapy (lithotripsy)

                        MDA 0305

                        Active non-implantable devices for stimulation or inhibition

                        MDA 0306

                        Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

                        MDA 0307

                        Active non-implantable respiratory devices

                        MDA 0308

                        Active non-implantable devices for wound and skin care

                        MDA 0309

                        Active non-implantable ophthalmologic devices

                        MDA 0310

                        Active non-implantable devices for ear, nose and throat

                        MDA 0311

                        Active non-implantable dental devices

                        MDA 0312

                        Other active non-implantable surgical devices

                        MDA 0313

                        Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport

                        MDA 0314

                        Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

                        MDA 0315

                        Software

                        MDA 0316

                        Medical gas supply systems and parts thereof

                        MDA 0317

                        Active non-implantable devices for cleaning, disinfection and sterilisation

                        MDA 0318

                        Other active non-implantable devices

               B)Non-active devices

               (1)Non-active implants and long term surgically invasive devices

                        MDN CODE

                        Non-active implants and long term surgically invasive devices

                        MDN 1101

                        Non-active cardiovascular, vascular and neurovascular implants

                        MDN 1102

                        Non-active osteo- and orthopaedic implants

                        MDN 1103

                        Non-active dental implants and dental materials

                        MDN 1104

                        Non-active soft tissue and other implants

               (2)Non-active non-implantable devices

                        MDN CODE

                        Non-active non-implantable devices

                        MDN 1201

                        Non-active non-implantable devices for anaesthesia, emergency and intensive care

                        MDN 1202

                        Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis

                        MDN 1203

                        Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools

                        MDN 1204

                        Non-active non-implantable devices for wound and skin care

                        MDN 1205

                        Non-active non-implantable orthopaedic and rehabilitation devices

                        MDN 1206

                        Non-active non-implantable ophthalmologic devices

                        MDN 1207

                        Non-active non-implantable diagnostic devices

                        MDN 1208

                        Non-active non-implantable instruments

                        MDN 1209

                        Non-active non-implantable dental materials

                        MDN 1210

                        Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases

                        MDN 1211

                        Non-active non-implantable devices for disinfecting, cleaning and rinsing

                        MDN 1212

                        Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

                        MDN 1213

                        Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route

                        MDN 1214

                        General non-active non-implantable devices used in health care and other non-active non-implantable devices

               IIHORIZONTAL CODES

               (1) Devices with specific characteristics

                        MDS CODE

                        Devices with specific characteristics

                        MDS 1001

                        Devices incorporating medicinal substances

                        MDS 1002

                        Devices manufactured utilising tissues or cells of human origin, or their derivatives

                        MDS 1003

                        Devices manufactured utilising tissues or cells of animal origin, or their derivatives

                        MDS 1004

                              1
                           Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council

                        MDS 1005

                        Devices in sterile condition

                        MDS 1006

                        Reusable surgical instruments

                        MDS 1007

                        Devices incorporating or consisting of nanomaterial

                        MDS 1008

                        Devices utilising biologically active coatings and / or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body

                        MDS 1009

                        Devices incorporating software / utilising software / controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices

                        MDS 1010

                        Devices with a measuring function

                        MDS 1011

                        Devices in systems or procedure packs

                        MDS 1012

                        Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745

                        MDS 1013

                        Class III custom-made implantable devices

                        MDS 1014

                        Devices incorporating as an integral part an in vitro diagnostic device

               (2) Devices for which specific technologies or processes are used

                        MDT CODE

                        Devices for which specific technologies or processes are used

                        MDT 2001

                        Devices manufactured using metal processing

                        MDT 2002

                        Devices manufactured using plastic processing

                        MDT 2003

                        Devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

                        MDT 2004

                        Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

                        MDT 2005

                        Devices manufactured using biotechnology

                        MDT 2006

                        Devices manufactured using chemical processing

                        MDT 2007

                        Devices which require knowledge regarding the production of pharmaceuticals

                        MDT 2008

                        Devices manufactured in clean rooms and associated controlled environments

                        MDT 2009

                        Devices manufactured using processing of materials of human, animal, or microbial origin

                        MDT 2010

                        Devices manufactured using electronic components including communication devices

                        MDT 2011

                        Devices which require packaging, including labelling

                        MDT 2012

                        Devices which require installation, refurbishment

                        MDT 2013

                        Devices which have undergone reprocessing

               ANNEX II

               The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746

               ICODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE

               (1)Devices intended to be used for blood grouping

                        IVR CODE

                        Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

                        IVR 0101

                        Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]

                        IVR 0102

                        Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]

                        IVR 0103

                        Devices intended to determine markers of the Kell system [Kel1 (K)]

                        IVR 0104

                        Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]

                        IVR 0105

                        Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]

                        IVR CODE

                        Other devices intended to be used for blood grouping

                        IVR 0106

                        Other devices intended to be used for blood grouping

               (2)Devices intended to be used for tissue typing

                        IVR CODE

                        Devices intended to be used for tissue typing

                        IVR 0201

                        Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration

                        IVR 0202

                        Other devices intended to be used for tissue typing

               (3)Devices intended to be used for markers of cancer and non-malignant tumours

                        IVR CODE

                        Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing

                        IVR 0301

                        Devices intended to be used in screening, diagnosis, staging or monitoring of cancer

                        IVR 0302

                        Other devices intended to be used for markers of cancer and non-malignant tumours

               (4)Devices intended to be used for human genetic testing

                        IVR CODE

                        Devices intended to be used for human genetic testing

                        IVR 0401

                        Devices intended to be used in screening / confirmation of congenital / inherited disorders

                        IVR 0402

                        Devices intended to be used to predict genetic disease/disorder risk and prognosis

                        IVR 0403

                        Other devices intended to be used for human genetic testing

               (5)Devices intended to be used to determine markers of infections / immune status

                        IVR CODE

                        Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune status

                        IVR 0501

                        Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents

                        IVR 0502

                        Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration

                        IVR 0503

                        Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents

                        IVR 0504

                        Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging

                        IVR 0505

                        Devices intended to be used to grow / isolate / identify and handle infectious agents

                        IVR 0506

                        Other devices intended to be used to determine markers of infections / immune status

               (6)Devices intended to be used for non-infectious pathologies, physiological markers, disorders / impairments (except human genetic testing), and therapeutic measures

                        IVR CODE

                        Devices intended to be used for a specific disease

                        IVR 0601

                        Devices intended to be used for screening / confirmation of specific disorders / impairments

                        IVR 0602

                        Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease

                        IVR 0603

                        Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances

                        IVR 0604

                        Other devices intended to be used for a specific disease

                        IVR CODE

                        Devices intended to be used to define or monitor physiological status and therapeutic measures

                        IVR 0605

                        Devices intended to be used for monitoring of levels of medicinal products, substances or biological components

                        IVR 0606

                        Devices intended to be used for non-infectious disease staging

                        IVR 0607

                        Devices intended to be used for detection of pregnancy or fertility testing

                        IVR 0608

                        Devices intended to be used for screening, determination or monitoring of physiological markers

                        IVR 0609

                        Other devices intended to be used to define or monitor physiological status and therapeutic measures

               (7)Devices which are controls without a quantitative or qualitative assigned value

                        IVR CODE

                        Controls without a quantitative or qualitative assigned value

                        IVR 0701

                        Devices which are controls without a quantitative assigned value

                        IVR 0702

                        Devices which are controls without a qualitative assigned value

               (8)Class A devices in sterile condition

                        IVR CODE

                        Class A devices in sterile condition

                        IVR 0801

                        Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746

                        IVR 0802

                        Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746

                        IVR 0803

                        Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746

               IIHORIZONTAL CODES

               (1)In vitro diagnostic devices with specific characteristics

                        IVS CODE

                        In vitro diagnostic devices with specific characteristics

                        IVS 1001

                        Devices intended to be used for near-patient testing

                        IVS 1002

                        Devices intended to be used for self-testing

                        IVS 1003

                        Devices intended to be used as companion diagnostics

                        IVS 1004

                        Devices manufactured utilising tissues or cells of human origin, or their derivatives

                        IVS 1005

                        Devices in sterile condition

                        IVS 1006

                        Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)

                        IVS 1007

                        Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)

                        IVS 1008

                        Instruments, equipment, systems or apparatus

                        IVS 1009

                        Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures

                        IVS 1010

                        Devices incorporating software / utilising software / controlled by software

               (2)In vitro diagnostic devices for which specific technologies are used

                        IVT CODE

                        In vitro diagnostic devices for which specific technologies are used

                        IVT 2001

                        In vitro diagnostic devices manufactured using metal processing

                        IVT 2002

                        In vitro diagnostic devices manufactured using plastic processing

                        IVT 2003

                        In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)

                        IVT 2004

                        In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)

                        IVT 2005

                        In vitro diagnostic devices manufactured using biotechnology

                        IVT 2006

                        In vitro diagnostic devices manufactured using chemical processing

                        IVT 2007

                        In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals

                        IVT 2008

                        In vitro diagnostic devices manufactured in clean rooms and associated controlled environments

                        IVT 2009

                        In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin

                        IVT 2010

                        In vitro diagnostic devices manufactured using electronic components including communication devices

                        IVT 2011

                        In vitro diagnostic devices which require packaging, including labelling

               (3)In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification

                        IVP CODE

                        In vitro diagnostic devices which require specific knowledge in examination procedures

                        IVP 3001

                        In vitro diagnostic devices which require knowledge regarding agglutination tests

                        IVP 3002

                        In vitro diagnostic devices which require knowledge regarding biochemistry

                        IVP 3003

                        In vitro diagnostic devices which require knowledge regarding chromatography

                        IVP 3004

                        In vitro diagnostic devices which require knowledge regarding chromosomal analysis

                        IVP 3005

                        In vitro diagnostic devices which require knowledge regarding coagulometry

                        IVP 3006

                        In vitro diagnostic devices which require knowledge regarding flow cytometry

                        IVP 3007

                        In vitro diagnostic devices which require knowledge regarding immunoassays

                        IVP 3008

                        In vitro diagnostic devices which require knowledge regarding lysis based testing

                        IVP 3009

                        In vitro diagnostic devices which require knowledge regarding measurement of radioactivity

                        IVP 3010

                        In vitro diagnostic devices which require knowledge regarding microscopy

                        IVP 3011

                        In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)

                        IVP 3012

                        In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry

                        IVP 3013

                        In vitro diagnostic devices which require knowledge regarding spectroscopy

                        IVP 3014

                        In vitro diagnostic devices which require knowledge regarding tests of cell function

               (4)In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

                        IVD CODE

                        In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification

                        IVD 4001

                        In vitro diagnostic devices which require knowledge regarding bacteriology

                        IVD 4002

                        In vitro diagnostic devices which require knowledge regarding clinical chemistry / biochemistry

                        IVD 4003

                        In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)

                        IVD 4004

                        In vitro diagnostic devices which require knowledge regarding genetics

                        IVD 4005

                        In vitro diagnostic devices which require knowledge regarding haematology / haemostasis, including coagulation disorders

                        IVD 4006

                        In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics

                        IVD 4007

                        In vitro diagnostic devices which require knowledge regarding immunohistochemistry / histology

                        IVD 4008

                        In vitro diagnostic devices which require knowledge regarding immunology

                        IVD 4009

                        In vitro diagnostic devices which require knowledge regarding molecular biology / diagnostics

                        IVD 4010

                        In vitro diagnostic devices which require knowledge regarding mycology

                        IVD 4011

                        In vitro diagnostic devices which require knowledge regarding parasitology

                        IVD 4012

                        In vitro diagnostic devices which require knowledge regarding virology

                     (1)

                        Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) (OJ L 157 9.6.2006, p. 24).


title: COMMISSION IMPLEMENTING REGULATION (EU) …/... on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council

text:
               COMMISSION IMPLEMENTING REGULATION (EU) …/...

               of 24.3.2017

               on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
                  1
               , and in particular Article 78(7) thereof,

               Whereas:

               (1)Regulation (EU) No 536/2014 lays down the legal framework for the conduct of clinical trials on medicinal products for human use in the Union to ensure that the rights, safety and well-being of the subjects are protected and the data generated in clinical trials are robust and reliable. In particular the sponsor of a clinical trial and the investigator are to ensure that the clinical trial is conducted in accordance with the relevant protocol and the principles of good clinical practice. Compliance with the applicable legal requirements, the protocol and the principles of good clinical practice, including with standards relating to data integrity and ethical conduct of the clinical trial, is to be verified by means of inspections conducted under the responsibility of the Member State where the inspection takes place.

               (2)The inspection in the context of clinical trials may concern good manufacturing practices as regards the manufacturing of the investigational medicinal products or good clinical practice as regards the conduct of clinical trials.  Article 63 of Regulation (EU) No 536/2014 empowers the Commission to adopt delegated acts specifying the detailed arrangements for good manufacturing practice inspections as regards investigational medicinal products. Therefore, this Regulation should only lay down detailed arrangements for good clinical practice inspections procedures and requirements regarding training and qualifications of good clinical practice inspectors.

               (3)Member States may conduct inspections of clinical trials performed in third countries either because a clinical trial is related to a clinical trial authorised in the Union or because the data of the clinical trial is being referred to in a clinical trial authorisation application in the Union. Those inspections should allow verifying whether such clinical trials were conducted in accordance with standards equivalent to Union standards. Inspections of clinical trials in third countries may also be conducted in order to verify whether the clinical trials, whose results are referred to in marketing authorisation applications in the Union, meet the ethical requirements set out in Regulation (EU) No 536/2014. Therefore, provisions on detailed arrangements for the inspection procedures should apply also to inspections conducted outside the Union in accordance with Regulation (EU) No 536/2014.

               (4)The International Conference on Harmonisation ("ICH") reached a consensus in 1995 to provide a harmonised approach for good clinical practice. Pursuant to Article 47 of Regulation (EU) No 536/2014, the ICH guidelines should be appropriately taken into account by the sponsor when drafting the clinical trial protocol and conducting the clinical trial. To the extent that those guidelines are compatible with the relevant Union law and EU guidelines, inspectors should refer to the ICH guidelines, taking into account the characteristics of each trial.

               (5)Member States should be required to set up quality systems to ensure that the inspection procedures are observed and consistently monitored. A well-functioning quality system should comprise an organisational structure, clear processes and procedures, including the standard operating procedures to be followed by inspectors when performing their tasks, clearly defined details of the inspectors' duties and responsibilities and ongoing training requirements, as well as adequate resources and mechanisms which aim at eliminating non-compliance.

               (6)It is necessary to enable inspectors to ensure the practical effectiveness of provisions on good clinical practice. That objective should be reflected in the minimum requirements for the qualification of inspectors, in particular as regards their education and training. For the same reasons, detailed rules on inspection procedures should be laid down.

               (7)In order to safeguard the effectiveness of inspection, the inspectors should be granted the necessary powers of access to the premises and data. This includes in particular any laboratory used for analysis in the clinical trial, any contract research organisation’s facilities or the sponsor's premises. They should also be empowered to contact the trial subjects in justified cases.

               (8)In order to ensure the compliance with arrangements for good clinical practice inspections and in accordance with Article 77 of Regulation (EU) No 536/2014 Member States should take corrective measures if necessary. When during an inspection a major non-compliance or breach is identified, or the inspectors' investigatory powers are not recognised by the sponsors, Member States should have recourse to penalties.

               (9)In order to ensure the protection of confidential information, in particular personal data of clinical trial subjects related to the health as well as commercially confidential information, the inspectors and experts involved in inspections should be bound by the highest standards of confidentiality and the applicable requirements of the Union law, national laws and international agreements. The inspectors and experts involved in inspections should comply with the requirements of Directive 95/46/EC of the European Parliament and of the Council
                  2
                when processing personal data.

               (10)Commission Directive 2005/28/EC
                  3
                should be repealed in order to ensure that only one set of rules applies to the conduct of good clinical practice inspections of clinical trials, including clinical trials governed by Directive 2001/20/EC of the European Parliament and of the Council
                  4
               . However, in order to ensure consistency with Article 98 of Regulation (EU) No 536/2014 setting up a transitional period maintaining, as regards certain requests for authorisation of a clinical trial, the applicability of Directive 2001/20/EC, Directive 2005/28/EC should, with the exception of its Chapters 5 and 6 referring to good clinical practice inspection procedures and inspectors, remain applicable during that transitional period to all clinical trials authorised on the basis of Directive 2001/20/EC.

               (11)This Regulation should become applicable at the same time as Regulation (EU) No 536/2014.

               (12)The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Medicinal Products for Human Use,

               HAS ADOPTED THIS REGULATION:

               Chapter I

               General provisions

               Article 1
               Scope

               This Regulation applies to inspections of:

               (a)clinical trials conducted in the Union, including clinical trial sites related to those trials but located outside the Union;

               (b)clinical trials referred to in the applications for clinical trial authorisations pursuant to Article 25(5) of Regulation (EU) No 536/2014;

               (c)clinical trials conducted in third countries and referred to in marketing authorisation applications in the Union.

               Article 2
               Timeframe for inspections

               Inspections may take place in any of the following circumstances:

               (a)before, during or after the conduct of clinical trial;

               (b)as part of the verification of applications for marketing authorisation;

               (c)as a follow-up to the granting of a marketing authorisation.

               Article 3
               Quality system

               1.Each Member State shall set up a properly designed quality system ensuring that the inspection procedures are observed and consistently monitored.

               Member States shall maintain those quality systems up to date.

               2.Each inspector shall have access to and comply with standard operating procedures, details of their duties, responsibilities and training requirements.

               Chapter II

               Inspectors

               Article 4
               Qualifications, training and experience

               1.Inspectors shall have completed education at university level, or have equivalent experience, in medicine, pharmacy, pharmacology, toxicology or other fields relevant to the principles of good clinical practice.

               2.Inspectors shall receive appropriate training, including participation in inspections. Their training needs, necessary to maintain or improve their skills, shall be assessed regularly by a person appointed for that task.

               3.Inspectors shall have knowledge of principles and processes that apply to the development of medicinal products and clinical research and have knowledge of applicable Union and national legislation and guidelines on the conduct of clinical trials and the granting of marketing authorisations.

               4.Inspectors shall have the ability to make professional judgments in relation to the compliance with applicable Union and national legislation and guidelines. They shall be able to assess data integrity as well as aspects related to ethical conduct of clinical trials.

               5.Inspectors shall be familiar with the procedures and technical methods for the recording and management of clinical data, and with the organisation and regulation of the healthcare systems in the relevant Member States and, where appropriate, in third countries.

               6.Inspectors shall be able to assess the degree of risk as regards the safety of the subjects enrolled in the clinical trial as well as the data integrity.

               7.Inspectors shall be aware of the applicable rules as regards confidentiality and protection of personal data.

               8.Member States shall keep records of the qualifications, training and experience of each inspector and maintain those records up-to-date for as long as inspector is in active duty.

               Article 5
               Conflict of interest and impartiality

               1.Inspectors shall be free from any influence which could affect their impartiality or their judgement.

               2.Inspectors shall not have conflicts of interest. In particular, they shall be independent of all of the following parties:

               (a)the sponsor;

               (b)the investigators involved in the clinical trial;

               (c)persons financing the clinical trial;

               (d)any other party involved in the conduct of the clinical trial.

               3.Each inspector shall make an annual declaration of their financial interests and other links to the parties to be potentially inspected. That declaration shall be taken into consideration for the purposes of assigning an inspector to a specific inspection.

               Chapter III

               Inspection Procedures

               Article 6
               Subject-matter of inspections

               1.Inspectors shall verify the compliance with the requirements of Regulation (EU) No 536/2014, including protection of the rights and well-being of the clinical trial subjects, the quality and integrity of data generated in clinical trial, the compliance with principles of good clinical practice, including the ethical aspects and the relevant national legislation.

               Article 7
               Procedures to be established by Member States

               1.Member States shall establish the relevant procedures for at least the following:

               (a)appointing experts to accompany inspectors, if additional expertise is required for an inspection;

               (b)arranging inspections outside the Union;

               (c)verification of good clinical practice compliance, including the modalities for examining the study management procedures and the conditions under which the clinical trial is planned, performed, monitored and recorded, as well as follow up measures, such as a review of an analysis of the root cause of a significant non-compliance and verification of corrective and preventive actions implemented by the sponsor.

               Member States shall make those procedures and rules publicly available.

               2.Member States shall also define the powers of experts appointed to accompany inspectors.

               Article 8
               Unannounced inspections

               The inspections may, where necessary, be carried out unannounced.

               Article 9
               Collaboration between Member States

               1.Member States shall collaborate with each other, with the Commission and with the European Medicines Agency to develop and improve commonly recognised standards of good clinical practice inspections. This collaboration may take the form of joint inspections, agreed processes and procedures and sharing of experience and training.

               2.The Commission shall make publicly available any guidance documents on the commonly recognised standards for the conduct of inspections, developed in collaboration with Member States and the European Medicines Agency.

               3.The European Medicines Agency shall process and make available to Member States information on inspections that are envisaged, scheduled, or conducted, in order to assist Member States to ensure the most efficient use of inspection resources when planning their inspections.

               4.Member States may request assistance from the national competent authority of another Member State in the matter of inspection.

               Article 10
               Powers of inspectors

               1.Inspections shall be carried out by inspectors appointed by Member States.

               In order to ensure the availability of necessary skills for each inspection, Member States may appoint teams of inspectors and appoint experts with appropriate qualifications to accompany inspectors.

               2.Inspectors shall be entitled to inspect the clinical trial sites, documents, facilities, records, including individual patients' records, quality arrangements, data and any other resources and entities that are deemed by the competent authority to be related to the clinical trial.

               3.When performing an inspection, the inspectors shall be empowered to enter into sites, other related premises, and to access to data, including individual patients' records.

               4.Inspectors shall be entitled to make copies of records and hardcopies, print outs of electronic records and take photos of premises and equipment.

               5.Inspectors shall be entitled to ask any representative or member of staff of the inspected entity and any party involved in the clinical trial for explanations relating to the subject matter and purpose of the inspection and to record the answer.

               6.Inspectors shall be empowered to contact the trial subjects directly, in particular in case of reasonable suspicion that they were not informed adequately of their participation in the clinical trial.

               7.Member States shall provide inspectors with suitable means of their identification.

               8.Member States shall establish a legal and administrative framework to ensure that inspectors from other Member States, on-request and where appropriate, have access to sites, any premise of any entity related to the clinical trial as well as to related data.

               Article 11
               Recognition of inspection conclusions

               Inspectors shall carry out inspections on behalf of the Union. The results of those inspections shall be recognised by all Member States.

               In case of divergences between Member States in relation to the verification of compliance with the applicable legislation, the Member States, or the European Medicines Agency within the framework of its powers as provided for in Regulation (EC) No 726/2004, shall inform the Commission. The Commission, after consulting those Member States and the European Medicines Agency, may request a new inspection.

               Article 12
               Resources

               Member Sates shall appoint an adequate number of inspectors to ensure effective verification of compliance of clinical trials with applicable requirements, as well as the timely reporting of inspection findings.

               Article 13
               Inspection reports and records

               Without prejudice to the obligation to submit the inspection reports via the EU Portal in accordance with Article 78(6) of Regulation (EU) No 536/2014, Member States shall keep for at least 25 years relevant records of national inspections as well as of the inspections performed outside their territory, including information on the outcome of the inspection as regards good clinical practice compliance status  as well as any action taken by the sponsor or Member State in the  follow up of the inspection. The inspection reports submitted through the EU portal shall not contain personal data of clinical trials subjects.

               Article 14
               Confidentiality

               The inspectors and experts appointed to the inspection team shall maintain the confidentiality of information to which they gain access as a result of good clinical practice inspections.

               CHAPTER IV

               FINAL PROVISIONS

               Article 15
               Repeal

               Directive 2005/28/EC is repealed from the date referred to in the second paragraph of Article 17.

               Article 16
               Transitional provisions

               Directive 2005/28/EC, except for its Chapters 5 and 6, shall continue to apply to the clinical trials governed by Directive 2001/20/EC pursuant to Article 98 of Regulation (EU) 536/2014.

               Article 17
               Entry into force

               This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               It shall apply from six months after the date of publication in the Official Journal of the European Union of the notice referred to in Article 82(3) of Regulation (EU) No 536/2014.

               This Regulation shall be binding in its entirety and directly applicable in all Member States.

               Done at Brussels, 24.3.2017

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 158, 27.05.2014, p. 1.

                     (2)

                        Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (OJ L 281, 23.11.2015, p. 31).

                     (3)

                        Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirement for authorisation of the manufacturing or importations of such products (OJ L 91, 9.4.2005, p.13).

                     (4)

                        Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (OJ L 121, 1.5.2001, p. 34).