What will be MDR (EU) 2017/745 impact on CE MDD certificates during the “period of grace”?

Home » FAQ » What will be MDR (EU) 2017/745 impact on CE MDD certificates during the "period of grace"?

What is the “period of grace” and how can I take advantage of it?

The "period of grace" is the time interval, which coincides with the due date, during which a CE certificate issued pursuant to Directive (MDD) 93/42/EEC can remain effective even after 26 May 2021, but not later than 26 May 2024. One of the conditions for a "period of grace" CE certificate to remain valid until [...]

What is the difference between market surveillance, post-market surveillance (PMS) and vigilance?

The "market surveillance" (performed by the Competent Authority) is the set of activities carried out and the measures taken to verify and guarantee that the devices are compliant with MDR (Art. 93) and IVDR (Art. 88). The ultimate goal is to ensure that devices placed on the market do not endanger health and safety. "Post-market [...]

What are the MDR requirements for post-market surveillance, market surveillance and vigilance?

To monitor the traceability of Medical Devices throughout the supply chain, the European Regulations place not only more stringent requirements for Manufacturers, but also expect greater involvement from other economic operators and Notified Bodies. Pursuant to MDR, the manufacturer must have in place: a quality management system (QMS);a post-market surveillance system (PMS);a risk management system;a [...]

What is the “post-market surveillance system”?

The post-market surveillance system (PMS) serves to “collect, record and actively and systematically analyze the relevant data on the quality, performance and safety of a device during the entire validity period, to draw the necessary conclusions and to determine, implement and monitor any preventive and corrective actions" (Ref. Art. 83 of the MDR). The need [...]

How can I continue to sell my devices after the full implementation of MDR?

The MDR certificate is a new certification and not an amendment of the Medical Device Directive (MDD) 93/42/EEC. However, pending the obtaining of a certificate of conformity pursuant to MDR, a medical device can continue to be marketed if it holds a valid CE certificate issued under MDD. A CE MDD certificate will remain valid [...]

Go to Top