• Medical Device Regulations (MDR)
• CE Marking
• MHRA Distributors Licence Requirements (Good Distribution Practice)

MDD to MDR

 Find out how these changes impact your product

The Medical Devices Regulation (MDR) (EU) 2017/745 and In-Vitro Diagnostic Devices (IVDR) Regulation (EU) 2017/746 came into force in May 2017 to enact comprehensive changes in the European legal framework for medical devices, introducing new responsibilities for Medical Devices manufacturers, importers and distributors, notified bodies and national competent authorities. The Medical Devices Regulation (MDR) was scheduled to fully apply from 26 May 2020 and In-Vitro Diagnostic Devices (IVDR) Regulation from 26 May 2022 (the Application dates); which is now pushed back by 12 months following the EC announcement and due to the COVID-19 pandemic.

A manufacturer can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment under the new EU MDR/IVDR, if it fully complies with these, or the previous EU Directives 93/42/EEC (MDD), 98/79/EC (IVDD) and 90/385/EEC (AIMDD) during the transitional periods. Doing so declares that product meets the prescribed legal requirements for such, and can be sold throughout the EEA without restrictions. This applies to products made in other countries that are sold in the EEA.

Devices, CE marks and MDR legal responsibilities

After the MDR Application date, relevant MDD or AIMDD certificates will remain valid until their expiration. MDD or AIMDD certificates issued for devices after the MDR came into force (25 May 2017) remain valid for up to five years, or until 27 May 2024 latest (whichever is soonest). Those medical devices meeting these conditions can be placed on the EU market until expiration of their certificate and may continue to be available in the supply chain until

27 May 2025.

Manufacturers that decide to keep their MDD or AIMDD certificates after the application of the MDR, shall consider the following factors:

• Must maintain compliance with the MDD or AIMDD;
• Must avoid significant changes in the design/intended purpose of the devices;
• Must fully comply with MDR from the date of Application for several aspects of the new legislation (e.g. stringent post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices, etc.);

The MDR requires the notified body that has issued the MDD or AIMDD certificate is responsible for surveillance in respect of all the above requirements.