CE Mark Certification for Medical Devices
A medical device can only be sold in Europe with a CE Mark. By placing the CE mark on a product, the manufacturer declares that its product complies with all applicable European Medical Device Regulations.
In May 2021, the European Medical Devices Regulation 2017/745 (MDR) will apply in the second largest medical device market. The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/ECC), will introduce major changes to how medical device manufacturers obtain European market access.
Qserve's roadmap to EU MDR Implementation:
Key changes MDR versus MDD
Product scope expansion - The definition of medical devices and active implantable medical devices covered under the MDR will be significantly expanded to include devices that have not a medical intended purpose.
Identification of "qualified person" - Device manufacturers will be required to identify at least one person within their organization who is ultimately responsible for all aspects of compliance with the requirements of the new regulation.
Implementation of unique device identification - The MDR mandates the use of unique device identification (UDI) mechanisms. This requirement is expected to increase the ability of manufacturers and Authorities to trace specific devices through the supply chain.
Reclassification of devices according to risk, contact duration, and invasiveness - The MDR will require device manufacturers to review the updated classification rules and update their technical documentation accordingly by considering the fact that class III and implantable devices will have higher clinical requirements and a regular scrutiny process.
Clinical evidence for class III and implantable medical devices - Manufacturers will need to conduct clinical investigations in case they do not have sufficient clinical evidence to support the claims done on both safety and performance of a dedicated device.
Clinical evaluation of Class IIa and Class IIb medical devices - Manufacturer will need to re-prepare their clinical evaluation by considering the new wording of the regulation on when an equivalence approach and under which circumstances it is possible to justify not conducting a clinical investigation.
Post-market oversight - The MDR request increased post-market surveillance authority by the Notified Body.
No "grandfathering" provisions - Under the MDR, all currently approved devices must be recertified in accordance with the new requirements.