Joint Implementation Plan for the EU MDR

by | Mar 30, 2020 | EU, EU MDR, OQA, QMS, Quality Systems, Requirements

The European Medical Device Coordination Group published a joint implementation plan ahead of the May 2020 deadline for the full implementation of the EU MDR. The plan addresses the concern that the implementation of the MDR has proven to be a challenging task for the medical device industry, European member states, and the EU commission and further mentions that the involved stakeholders must step up their efforts to achieve the May 2020 deadline.1

The joint implementation plan sets the priorities and contingency actions that are essential to have a  fully operational EU MDR compliant system in place by May 2020. The plan prioritizes the following elements pertaining to the medical device regulations:

EUDAMED

Roll out of the EUDAMED database has been delayed, however, the plan endorses that a delay in implementation of the database should not prevent the timely application of the MDR. The EU Commission is prioritizing the release of the actor module of the EUDAMED by 26th May 2020 and gradually releasing the other modules with a target completion date set in May 2022.1

Placing safe devices on the market after May 26, 2020

The biggest challenge that the industry will have to face with the implementation of the MDR is a shortage of medical devices due to the limited number of notified bodies available to certify medical devices, as well as companies that are pulling out their devices off the market. Though 11 notified bodies are accredited by the EU to carry out conformity assessments, the concerns remain on the capacity of the notified bodies.1

Switzerland’s exit from the EU

If the EU-Switzerland Mutual Recognition Agreement is not updated by 26 May 2020, then the conformity certificates issued by the Swiss notified bodies will become invalid. To place a medical device in the EU market, the manufactures will have to transfer their certificates to an EU based notified body. In addition to that, Switzerland will be considered a third country and Swiss-based manufacturers will need an authorized representative in the EU.1

Clarification regarding clinical evaluations and expert panels

With the stringent requirements established in the MDR for clinical data, clinical evaluation, post-market clinical studies, manufacturers are in need of clarifications to understand what an adequate approach would be to apply for their products. The work to set up an expert panel to evaluate the clinical requirements of the regulations as well as making guidance documents available to the industry to support in implementing these requirements is advancing.1

Monitoring

The EU Commission intends to request regular updates from the industry and the NBs to monitor the implementation and the transition progress ahead of May 2020 and beyond.1

These priorities have been identified based on the objectives of public health, patient safety, and transparency. The EU Commission’s efforts to work on the priorities mentioned above is ongoing. It is worth noting that focusing on a limited set of agreed-upon priorities could result in temporarily fewer resources being placed into other areas. However, patient access to safe and efficient medical devices will be at the forefront of all the implementation efforts.1

Need help with your EU MDR transition. Call us today at 248-987-4497 or email us at info@emmainternational.com to see how we can help.


1Medical Device Coordination Group (March 2020) retrieved on 03/17/2020 from https://ec.europa.eu/docsroom/documents/40286?locale=en

 

Nikita Angane

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This