EU MDR Three Months Out: A Checklist

EU MDR Three Months Out: A Checklist

For medical device companies in the European Union (EU), the May 26, 2020, application date for the EU Medical Device Regulation (MDR) looms large on the horizon. Failing to meet this deadline means companies will not be able to introduce products into the European Economic Area.

First introduced in 2017, companies in scope of the new regulation have enjoyed a three-year transition period to recertify their products ahead of May 2020. However, with only a handful of notified bodies approved for EU MDR certification and complex reporting requirements, ensuring compliance with the regulation is a time-consuming process.

With just three months to go until the deadline, time is running out. Understanding where your company stands with regard to the EU MDR certification process is vital for meeting regulatory requirements on time and ensuring continued market access.


Download our guide, Building an Effective EU Medical Device Regulation Program, to get the most out of your program.


The EU MDR Compliance Checklist: Tracking Progress to Date

The process for ensuring medical devices are fully-compliant and certified under the EU MDR is resource-intensive, requiring considerable effort. This process should ideally have begun shortly after the announcement of the EU MDR in 2017.

By early 2020, medical device companies should have completed several tasks to meet the May 26 deadline:

  • Product Scoping: A wider range of products are in scope of the MDR when compared with the Medical Device Directive (MDD) it replaced. For example, new criteria in the MDR bring a variety of products and devices without a specific medical purpose into scope, including lotion or gel dispensers, colored contact lenses and throat lozenges. There are also 22 rules outlined in the regulation’s legal text to determine an in-scope product’s classification, which informs reporting responsibilities.
  • Gap Analysis: Once products have been scoped, companies should determine what data they need to gather to demonstrate compliance. Based on the scoping and classification efforts, some products may only require minimal data and a self-certification, while others will require significantly more effort. Leveraging data sets under the MDD helps companies identify the data they have, and the information they will need to gather from their supply chain.
  • Gather Data: Under Section 10.4 of the EU MDR, companies must collect a wide variety of data on substances used in the production of medical devices and report this data on a per-article basis. Gathering this information requires significant supplier engagement to collect declarations on the substances, parts and materials in scope of the regulation.
  • Validate Data: Once data has been collected, it must be validated and verified. Regardless of the data required for a product, all products will require proof of an approved quality management system and a technical file. Using a cloud-based platform solution such as the Assent Compliance Platform helps companies gather and manage this data effectively.
  • Prepare Technical Files for Notified Body Approval: The data gathered through an EU MDR compliance program must be compiled into an accurate technical file for each product in scope of the regulation. These technical files are then sent to notified bodies, which certify the product.

The Impact of the EUDAMED Delay

Companies with products in scope of the EU MDR must submit data to the European Database on Medical Devices (EUDAMED), which in an earlier European Commission announcement was delayed until May 2022.

An interim EUDAMED database is expected to be announced soon, along with the required tasks to support the EU MDR medical device product approval process. The legal text of the regulation allows for this, as Article 123(3)(d) states the provisions of Directives 90/385/EEC and 93/42/EEC regarding the exchange of information (such as vigilance reporting, clinical investigations, device registration and certificate notifications) shall apply until EUDAMED is fully functional.

It should also be noted some of the legacy notified bodies under these provisions may no longer be accessible, as they may no longer exist as a notified body or may have transitioned to the EU MDR.

Countdown to May 2020

In the lead up to the May 26, 2020 application date, companies must finalize the product certification process by submitting product technical files to a notified body. Once approval has been secured from a notified body, a CE marking can be affixed to the certified product, which means it can be placed in the EEA.

While this is the final step in demonstrating compliance with the EU MDR, the process can take up to 14 months to complete from the initial submission to a notified body. According to a recent KPMG survey of medical device companies, only 27 percent of respondents expect to be fully compliant with the EU MDR by May 26, 2020. Furthermore, there are currently only nine designated notified bodies that can certify devices under the regulation. This shortage will likely continue to create bottlenecks in the approval process.

If in-scope companies cannot meet the May 26 date of application deadline, they may lose market access or face enforcement action. A comprehensive supply chain data management solution such as the Assent Compliance Platform helps companies collect and manage the data they need to meet their requirements under regulations such as the EU MDR. Contact us at info@assentcompliance.com to learn more.

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