The European Commission has announced today that it is working on a proposal to postpone the application date of the Medical Devices Regulation 2017/745 (“MDR”) for one year.  This proposal is to relieve the pressure on national authorities, notified bodies, manufacturers and other actors so they can focus on responding to the COVID-19 outbreak.  According to the Commission spokesman, the goal is:

“to submit this proposal early April and we call on Parliament and on Council to adopt it quickly, as the deadline for entry into force is at the end of May.”

This will be welcome news to all manufacturers of medical devices intended for the EU market, as well as other economic operators in the supply chain.  The postponement of the implementation date will allow companies to deploy resources to address the current pandemic and will give them extra time to become MDR-compliant.

InsideEULifeSciences will continue to monitor developments and publish updates as they come in.

Tags: covid19, European Commission, Medical Devices
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Photo of Sarah Cowlishaw Sarah Cowlishaw

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU…

Advising clients on a broad range of life sciences matters, Sarah Cowlishaw supports innovative pharmaceutical, biotech, medical device, diagnostic and technology companies on regulatory, compliance, transactional, and legislative matters.

Sarah is a partner in London and Dublin practicing in the areas of EU, UK and Irish life sciences law. She has particular expertise in medical devices and diagnostics, and on advising on legal issues presented by digital health technologies, helping companies navigate regulatory frameworks while balancing challenges presented by the pace of technological change over legislative developments.

Sarah is a co-chair of Covington’s multidisciplinary Digital Health Initiative, which brings together the firm’s considerable resources across the broad array of legal, regulatory, commercial, and policy issues relating to the development and exploitation of digital health products and services.

Sarah regularly advises on:

  • obligations under the EU Medical Devices Regulation and In Vitro Diagnostics Medical Devices Regulation, including associated transition issues, and UK-specific considerations caused by Brexit;
  • medical device CE and UKCA marking, quality systems, device vigilance and rules governing clinical investigations and performance evaluations of medical devices and in vitro diagnostics;
  • borderline classification determinations for software medical devices;
  • legal issues presented by digital health technologies including artificial intelligence;
  • general regulatory matters for the pharma and device industry, including borderline determinations, adverse event and other reporting obligations, manufacturing controls, and labeling and promotion;
  • the full range of agreements that span the product life-cycle in the life sciences sector, including collaborations and other strategic agreements, clinical trial agreements, and manufacturing and supply agreements; and
  • regulatory and commercial due diligence for life sciences transactions.

Sarah has been recognized as one of the UK’s Rising Stars by Law.com (2021), which lists 25 up and coming female lawyers in the UK. She was named among the Hot 100 by The Lawyer (2020) and was included in the 50 Movers & Shakers in BioBusiness 2019 for advancing legal thinking for digital health.

Sarah is also Graduate Recruitment Partner for Covington’s London office.

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