The new European regulatory framework for medical devices
The new Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745) and In Vitro Diagnostic Device Regulation (EU IVDR) (Regulation (EU) 2017/746) will provide a new regulatory framework for medical devices in the European Union (EU).
The EU MDR will replace the existing Medical Devices Directive (Council Directive 93/42/EEC on Medical Devices (MDD) (1993)) and Active Implantable Medical Devices Directive (Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990) and the EU IVDR will replace the IVD Directive (Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998)).
MDR/IVDR: What’s new?
- No grandfathering for products already CE-marked, and no grandfathering for Notified Bodies are allowed under the EU MDR/IVDR.
- The EU MDR absorbs the AIMD.
- Products manufactured utilising nonviable human tissues or cells and/or their derivatives are regulated under the EU MDR.
- New specific definitions and regulatory requirements for ‘devices for self-testing,’ ‘devices for near-patient testing,’ ‘single-use devices’ and ‘kits’ are provided in the EU IVDR.
- Laboratory-developed tests (home brew tests) and companion diagnostics are regulated under the EU IVDR.
- The definition of “accessory” changes under the EU IVDR (extension of the scope).
- The “Supply Chain Controls” (Manufacturer, Authorised Representative, Importer and Distributor (MAID) actors) have been implemented under the EU MDR/IVDR.
- A new traceability system with the unique device identifiers (UDIs) (Eudamed system) has been set up under the EU MDR/IVDR.
- A Joint Action Plan to improve Notified Bodies’quality (re-application for MDR/IVDR accreditation, vigilance reporting, unannounced inspections, etc.) has been implemented under the EU MDR/IVDR.
- More clinical evidences (both pre- and postmarket) are required under the EUMDR/IVDR.
- More regulatory awareness levels are expected from companies under the EU MDR/IVDR.
- A centralised clinical trial regime (notification in a centralised database) has been implemented under the EU MDR/IVDR.
- The Common Specification adoption mechanism for general safety and performance requirements, technical documentation, clinical evaluation and postmarket clinical follow-up or clinical investigation requirements has been implemented under the EU MDR/IVDR.
- Details of the EU MDR classification and conformity assessment procedures have been updated.
- The IVD classification system has been radically updated.
- Requirements for own-brand labelling (OBL) and single-use device reprocessing change drastically under the EU IVDR.
Key Dates
May 26, 2017 – MDR/IVDR entry into force.
May 26, 2020 – MDR date of application (enforcement).
May 2022 – EC certificates of conformity issued before May 27, 2017 expire.
May 2024 – Required for all EC certificates issued 5 years from the issue/renewal date or 4 years from the MDR date of application whichever comes first.
May 2025 – Devices certified under the MDD can no longer be sold or distributed.
May 26, 2022 – IVDR date of application (enforcement).
May 2024 – Existing IVDD certificates expire.
May 2025 – IVDD devices off EU market.
Recommended Reading
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU