Preparing for Europe’s Evolving Medical Device Regulation

Section 1: Introduction

Your MDR Transition Starts Now

Do you have a set roadmap for certifying your devices under the European Union (EU) Medical Device Regulation (MDR)? If you currently market and sell medical devices in the European Economic Area (EEA) or are planning to do so in the near future—now is the time to put the proper measures and systems in place to ensure compliance.

On May 25, 2017, the European Commission published the Medical Device Regulation (MDR) 2017/745^1,2, which introduced an expansive set of new rules for how medical devices are regulated in the European Union (EU). The goal was to replace decades-old legislation with regulations that are more in line with the latest technological advances and medical science and create a more transparent regulatory framework that helps improve patient safety.

The new regulation provides stricter oversight in many areas as compared to the EU’s previous Active Implantable Medical Device Directive (AIMDD) and Medical Device Directive (MDD).

Some noteworthy changes include:

• Greater emphasis on the entire product lifecycle as opposed to just the pre-approval stage
• Broadened definition of medical device to include some non-medical and cosmetic devices
• Reclassification of some medical devices to higher risk categories
• Greater emphasis on post-market surveillance
• More stringent requirements for clinical evidence
• Greater supervision over notified bodies

As of May 26, 2021, new devices should have been certified and existing devices recertified under the MDR. This requires manufacturers to revisit their quality management system (QMS) and update core processes to ensure compliance. Ultimately, manufacturers that fail to comply with the MDR could face costly fines, litigation, design changes, product recalls, or lack of access to the EU market.

Navigating the regulation and figuring out where to start can be daunting. In this guide, we highlight the new MDR requirements that will have the greatest impact on your quality management processes and product portfolio. We also provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution can help simplify compliance.

Important Dates for EU MDR Transition

Manufacturers will need to recertify existing devices and certify new devices according to this timeline:

Extended Transition Period for Certain Medical Devices

On March 20, 2023, the European Commission issued Regulation (EU) 2023/607, which extends the transition period for certain devices that were certified under the EU’s previous Medical Device Directive (MDD) or Active Implantable Medical Device Directive (AIMDD) as follows:

• Class III and Class IIb implantable devices (except for sutures, staples, and certain dental devices): December 31, 2027
• Class IIa and Class IIb devices not covered above, Class Is, and Class Im devices: December 31, 2028
• Devices with a declaration of conformity dated prior to March 26, 2021: December 31, 2028

Furthermore, the sell-off date for MDD- and AIMDD-certified devices that were already placed on the market has been removed, enabling these devices to remain available for purchase in the EU.

Arena QMS Tip:

Custom Attributes and Arena Training

To keep track of upcoming certification dates for your medical devices, create a next-due-date custom attribute for each product and generate a report. Also assign product certification due dates to training plans so that owners receive automatic reminders.