(EU) 2017/745 New Medical Device Regulation is coming..
One of the most important elements of MDR (EU) 2017/745, is Clinical Evaluation Reporting (CER).
Medaval is ready for MDR with the following range of Clinical Evaluation Reporting (CER) services for Manufacturers offered to Class 1m or 11a Devices in the categories of Blood Pressure Monitors and Blood Glucose Meters, in support of the clinical data that will be required of you for your Notified Body.
There are stringent requirements under MEDDEV 2.7/1 rev 4 for demonstrating equivalence.
Only devices with equivalence to MEDDEV 2.7/1 rev 4 standards will be recognised under MDR after May 2020.All historic device equivalences, will not be recognised under MDR, after May 2020.
As Medaval’s Comparative Equivalence complies with MEDDEV 2.7/1 rev 4 applications can be assessed now to create a family of devices.
All Medaval’s MDR Services are “Advisory Board Member Approved Services”, on the date of service and represent some of most eminent experts in Blood Pressure Measurement.
CES for Blood Pressure Monitors & Blood Glucose Meters involves the comparison of the Device Registration Form details to the directive MEDEV 2.7/1,rev 4.
CES identifies, with proof, devices that use the same measurement technology. The set of devices with the same measurement technology are referred to as a “family”.
Device Registration Forms (DRF). These are Medaval’s standard forms containing the required device details to enable equivalence comparisons according to MEDDEV 2.7/1 rev 4 requirements.
Clinical Validations. Validation is considered to be of a measurement technology, for which any device, using that technology can be used. The Clinical Evaluation Report, under MDR, specifies that it is the measurement technology that is validated. The results apply to all devices proven to use that same technology.
Medaval awards a Certificate of Accreditation to devices that have been proven to be accurate, for a particular function, according to a specified protocol.
These are all support services for Clinical Evaluation Reporting (CER) that all manufacturers of Class 1m or Class 11a devices will require for their Notified Bodies. More detailed information can be obtained after subscribing to our members area.
The count down has started on over 1,000 Blood Pressure Monitors requiring Clinical Evaluation, but time will run out for many, unless manufacturers act now.