Section 1: Introduction

Your MDR Transition Starts Now

Do you have a set roadmap for certifying your devices under the new 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 new 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 new 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:

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.