News & Innovation
The European Union Medical Device Regulation (MDR) 2017/745
April 18, 2022
The European Union (EU) adopted the MDR almost 10 years after it launched a formal review of the European Regulatory framework. The MDR came into force on 26 May 2017 and became applicable on 26 May 2021 in all EU member states. This new regulation has replaced the earlier Medical Device Directive (MDD) and sets new rules for applying the ‘CE’ mark to medical devices (MDs).
What the MDR brings with it
The new regulations aim to bring about serious improvements to the current system. The new rules will bring1:
- Stricter pre-market control for high-risk devices with the involvement of a pool of experts at the EU level
- The reinforcement of the criteria for designation and processes for oversight of notified bodies
- The inclusion of aesthetic and cosmetic devices (Eg: contact lenses, collagen implants, tattoo removal equipment, liposuction equipment and dermal fillers) under the scope of the regulations.
- Improved transparency through a comprehensive EU database on medical devices and a device traceability system based on a unique device identification
- The introduction of an ‘implant card’ for patients containing information about implanted medical devices
- The reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorising multi-centre clinical investigations
- The strengthening of post-market surveillance requirements for manufacturers
- Improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance
Why the MDR is important
The EU MDR aims to ensure the smooth functioning of the internal market as regards medical devices, taking as a base a high level of protection of the health of patients and users. The regulation also sets high standards of quality and safety for medical devices to meet common safety concerns by ensuring, among other things, that the data generated in clinical investigations are reliable and robust and that the safety of the subjects participating in a clinical investigation is protected.
BD and MDR
As a leader in healthcare and patient safety, BD is driving the implementation of policies and procedures to ensure compliance with the MDR. We are currently conducting a close review of our product portfolio to drive efficiency where possible. We at BD are committed to serving our customers by delivering safe and effective medical devices that comply with all existing regulations.
1 European Commission, Medical Devices – New Regulations, Overview. https://ec.europa.eu/health/medical-devices-new-regulations/overview_en. Last updated 7 February 2022.
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