Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). In 2017 two new regulations – one on medical devices and the other on in vitro diagnostic medical devices entered into force. The Medical Devices Regulation (MDR) replaces the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMD). The In vitro diagnostic Medical Devices Regulation (IVDR) replaces the In Vitro Diagnostic Medical Devices Directive (IVDMD). As of May 2017, this new European legislation is in force and applies to all medical device manufacturers who intend to place their products in the European Union (EU).
The new rules will only fully apply after a transitional period. Based on the adoption of the amendment to postpone the application of the MDR by 1 year (European Commission, 23 April 2020), that period lasts for 4 years (instead of 3) after the entry into force of the MDR (i.e. until May 2021). This postponement takes the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus crisis. For the in vitro diagnostic medical devices the transitional period is 5 years after the entry into force of the IVDR (i.e. until May 2022).
The aim of the MDR and IVDR is to increase patient safety and to ensure that innovative medical devices remain available to patients.
The legislation will significantly increase the regulatory and liability burden for manufacturers and suppliers of these products. Most Life Sciences companies face very challenging timelines to comply with this legislation: by May 2021 for general medical devices, and by May 2022 for in vitro diagnostic medical devices.
The key changes of the MDR/IMDR
- Wider scope of regulated medical devices
- More stringent clinical evidence and documentation
- Increased focus on identification and traceability
- Definition of common specification
- Unannounced factory audits
- Increased Notified Body authority and/or involvement
- More rigorous vigilance and market surveillance
- At least one person responsible for regulatory compliance
Some of the challenges we see
- Notified bodies situation
- Software as Medical Device
- Scope of MDR / Definition
- New economic operators
- Product liability
- Inducement rules