Brexit Deal Rejected. Medical Device Industry Confused.

by | Jan 25, 2019 | Brexit, EU, EU MDR, Medical Devices, Quality Systems, Regulatory

With the fast approaching Brexit date, the possibilities of Britain exiting the EU without striking a deal are very high. Prime Minister Theresa May’s exit agreement was rejected by the British Parliament on January 15, 2019, by 432 votes to 202. The deal was designed to set forth a plan to facilitate a smooth transition period until December 2020 and to allow a free trade deal.

We discussed the impact of a ‘No-Deal Brexit’ on the Medical Device industry in our blog A NO-DEAL BREXIT AND THE IMPACT ON MEDICAL DEVICES. In these highly uncertain times, it is best to prepare for the worst, that is to prepare for a no deal Brexit.  The British Government recently updated it’s guidance document on how medicines, medical devices, and clinical trials would be regulated if there’s no Brexit deal.1

The document states that the UK will continue to recognize medical devices approved for the EU market that are CE-marked. It also states that the UK will comply with the requirements of the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) which are set to get into effect beginning May 2020 and 2022 respectively. However, the formal presence of the UK members at EU committees in respect to medical devices will cease.

At this point preparing for a no deal means appointing an authorized representative for your company in the EU as well as the UK. Also, make sure to transfer your certificates to an EU based notified body to continue marketing your medical device in the EU since a no deal will affect the validity of certificates issued by UK based notified bodies.

After the rejection of Theresa May’s deal, the political scenario in the UK is hinting towards delaying the Brexit or having a second referendumbecause under any condition, a no deal exit will give birth to major disruptions in trade, healthcare, and businesses all over the world.

Theresa May has been asked to come up with a plan B post the rejection of the latest withdrawal agreement. With only ten weeks left for Britain to exit the EU, it will be interesting to see how the modified version of the withdrawal agreement will be received by the UK Parliament.

In the meantime, if you have any questions on what you need to do to market your device in the EU and the UK, please call EMMA International at 248-987-4497 or email us at info@emmainternational.com.


1Department of Health & Social Care (Jan 2019) How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal retrieved on 01/22/2019 from https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-egulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

2PBS news hour (Jan 2019) Parliament just rejected May’s Brexit deal. Now what? Retrieved on 01/22/2019 from https://www.pbs.org/newshour/world/parliament-just-rejected-mays-brexit-deal-now-what

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.

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