Since 25 May 2017 the Regulation (EU) 2017/745 on medical devices 2017/746 (= MDR) and since 26 May 2022 the Regulation on in-vitro diagnostic medical devices (= IVDR), respectively, are in force. After a transition period of 4 or 5 years, respectively, they replaced the directives MDD (93/42/EEC)/AIMD (90/382/EEC) and IVDD (98/79/EC). In order to ensure continuing supply of essential devices, the EU Commission decided to allow placing on the market of medical devices with valid MDD certificates until 31 December 2027/2028 under certain provisions. IVDs with a valid IVDD certificate may even be placed on the market without a timely limit.

Contrary to the former directives MDR and IVDR are effective without implementation into national laws. Thus, compliance is mandatory. MDR and IVDR are more specific than MDD/AIMD and IVDD have been. Besides, they contain some remarkable changes especially in the following areas:

• Classifications (especially IVDR)
• General Safety and Performance Requirements
• Conformity Assessment Procedure
• Technical Documentation (specified in detail in Annexes II and III)
• Risk Management (explicitly included and required in several places)
• Clinical/Performance Evaluation and Investigation
• new: Unique Device Identification (UDI)
• Post-market Surveillance (new: unannounced on-site audits and reports to the respective Notified Body)
• QM System (required for manufacturers of class I products as well)

Furthermore, now explicitly mentioned:

• Usability and
• Biocompatibility

As I did hold a leading position with an EU Notified Body, I can support you to adapt your QM system and the technical documentation of your products to comply with MDR/IVDR requirements.

Due to coronavirus pandemic the implementation of MDR and IVDR had been postponed. Nevertheless, as both periods have elapsed meanwhile you should use any remaining time of validity of your MDD/IVDD certificate to get ready for MDR/IVDR.