Brexit and the Impact on the IVD and MD Industries


2020-bl-qarad-brexit_715x320The United Kingdom (UK) leaves the European Union (EU) on January 1, 2021. Manufacturers wanting to begin or continue business within the UK need to understand the implications of this move and should start making preparations today.

Understand Brexit

Since the results of the referendum held on June 23, 2016 decided that the people of the UK would prefer to leave the European Union, the term “Brexit” has become standard terminology. The British (BR) people will leave (EXIT) the EU.

However, the exact implications were unclear for a long time. There has been a long discussion to decide whether UK would prefer a soft Brexit, with minimal political and business implications, or a hard Brexit, where they will clearly differentiate themselves from the other countries.

It recently became clear the UK favors a hard Brexit. New rules with a profound impact on the international business community go into effect on January 1, 2021. As with all sectors, the IVD and MD industry will see significant changes. Manufacturers should definitely start preparing if they intend to continue their business in the United Kingdom after 2020.

Impact on the IVD and MD Industry

The UK government is poised for a hard Brexit, meaning the UK becomes a third country. This has serious consequences on the IVD and MD industry:

  • UK manufacturers will need an Authorized Representative to legally place their devices on the EU market.
  • Third-country manufacturers with a UK based Authorized Representative will need to transfer to another Authorized Representative which is still located in an EU member state.
  • New local UK registration requirements will have to be implemented.

The new regulations that amend the UK’s Medical Device Regulation laid down by UK parliament at the beginning of 2019 introduced the concept of a “UK Responsible Person” Similar to the European idea of an Authorized Representative, the UK Responsible Person would act on behalf of a manufacturer established outside the UK.

The UK responsible person must ensure that the declaration of conformity and technical documentation have been drawn up. He shall also cooperate with the Secretary of State on any preventive or corrective actions (CAPA) regarding to the products and inform the manufacturer about complaints and reports about suspected incidents related to a device for which they have been designated.
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Conclusion

The impact of Brexit on the IVD and Medical Device industry should not be overlooked. Non-UK manufacturers that intend to (continue to) sell their products in the UK after January 1, 2021, must appoint a UK Responsible Person as soon as possible. It is highly recommended to choose an independent organization over UK distributors to separate your commercial and regulatory interests in the United Kingdom.


dirk_stynen
Dr. Dirk Stynen is Owner, President and Principal Consultant at Qarad. The company specializes in regulatory affairs and quality systems for the IVD and Medical Device industry. They recently opened a new office based in the UK to provide an answer to the concerns regarding Brexit.

Prior to founding Qarad in 2000, Stynen spent 15 years in academic and industrial settings where he provided research and development experience in fields such as biochemistry, cell biology, molecular immunology, microbiology and virology.

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