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Author: Jerry Sudduth, Regulatory Consultant

The EU Medical Devices Regulation (MDR) Date of Application (DoA) takes effect today. Do you understand what your regulatory obligations will be? When it comes to transitioning from the MDD to the MDR, a little planning can go a long way. With a solid understanding of the transition timeline and what changes to expect, medical device manufacturers are well-positioned to meet new regulatory requirements in the EU.

The good news for manufacturers is that the European Union Medical Device Regulation (MDR) now holds notified bodies equally responsible for the quality and safety of medical devices.

Transitioning to the MDR will be most challenging for notified bodies. Manufacturers who already meet FDA requirements should feel confident that they’ve already completed most of the MDR requirements and should focus their efforts on documentation changes.

My advice to medical device manufacturers is to stop panicking and start planning for the transition.

You can prepare with the following resources:

  • Transition timeline
  • Critical changes for manufacturers
  • 3-Step plan of action
EU MDR Timeline

The most common question QA Consulting hears from clients is: What is the deadline for compliance?

Due to the COVID-19 pandemic, the EU MDR deadline was delayed by one year. Enforcement begins on May 26, 2021, and the last possible date for placing devices on the market under the MDD is May 26, 2024.

Your product’s compliance deadline is tied to the expiration date of its CE marking:

  • Medical devices with a CE marking that expires BEFORE May 26, 2021, may maintain compliance with the MDD and are not required to comply with the MDR until recertification.
  • Medical devices with a CE marking that expires AFTER May 26, 2021, must comply with the MDR.
What Critical Changes Should Manufacturers Be Aware Of?

Here are the three significant changes every medical device manufacturer should take into consideration in their transition plan:

  1. Recertification: Existing products must be recertified under the new regulations. Current CE-marked devices will be assessed on a more stringent evaluation of the clinical data for safety and effectiveness to prove claims. There is no grandfathering of devices.
  2. Unique Device Identification: Products must be marked with a unique device identification (UDI) system to help track and trace devices.
  3. EUDAMED Database: The EU is launching EUDAMED, a centralized portal so patients can access relevant safety information. Manufacturers must report all incidents, injuries, and deaths.

There are also two “gotcha” updates that might fly under your radar:

  1. Product scope expansion: The devices that will fall under the purview of the MDR are greatly expanded.
  2. Person Responsible for Regulatory Compliance (PRRC): Moving forward, companies must have a PRRC with a minimum of a bachelor’s degree and eight years of regulatory experience to oversee regulatory compliance functions.
EU MDR Transition 3-Step Action Plan

Once again, no need to panic if you plan ahead.

Here’s your three-step action plan to make sure you’re ready:

  1. Determine what changes need to be made by reviewing EU MDR Article 10 – General obligations of manufacturers.
  2. Create a plan to execute the necessary changes to your QMS and technical documentation.
  3. Implement the quality plan.
Lean Into Our EU MDR Expertise

Still unsure about transitioning from MDD to MDR? Hiring a consulting firm with experience in medical device quality consulting services offer unparalleled peace of mind.

Let’s get the conversation started