Brexit agreement begins now: Are you ready?

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Brexit agreement begins now: Are you ready?

December 30, 2020
Business Affairs European News

8. Repaired and remanufactured devices.
The Agreement does provide (in Article Goods 8) that a customs duty does not apply, regardless of its origin, if the "repaired" goods re-enter the party’s territory after the good was temporarily exported from its territory to the territory of the other party for repair. Remanufactured goods are to be treated in the same way as new goods. It was interesting to note that if either the EU or the U.K. adopt restrictions with respect to used goods, these restrictions will not apply to remanufactured goods. I did not locate any other discussion with regard to "used" goods.

9. Know the chemicals in your medical equipment and if your devices are properly registered.

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EU rules on registration, evaluation, authorization and restriction of chemicals (“REACH”) will no longer apply in the U.K. Though the EU REACH requirements will not apply in the U.K., the U.K. will have U.K. REACH Regime. There seems to be a transition period until October 28, 2021 for the new U.K. regime to be adopted. In general, I did not locate anything in the Agreement to suggest that these EU rules will be relaxed when it comes to U.K./EU trade. Sellers/Buyers will want to factor in the REACH and the U.K. Reach Regime compliance in purchases/sales.

10. Certificates, authorizations, markings and labelling.
The situation is similarly complicated for application of the EU RoHS Directive and the U.K. corresponding regime. The Conformite Europeenne marking (CE) which is the most recognized indicium of compliance, will no longer apply in the U.K. For most CE marked goods there will be a one-year transition period in the UK. It is worth reviewing the 2019 U.K. guidance for businesses moving to a U.K. Conformity Assessed Marking.

Robert J. Kerwin
Much more may be said in future articles as to the terms of this expansive agreement concerning such matters as new immigration systems, service providers, foreign nationals and/or companies outside the EU, contracts, jurisdiction, intellectual property rights and personal data. Suffice it to say that the Agreement may have, notwithstanding the pronouncements, significant impact on business operations.

About the author: Robert Kerwin is General Counsel to the International Association of Medical Equipment Remarketers and Servicers (“IAMERS”). This article does not constitute legal advice concerning the EU-U.K. agreement or otherwise. Readers are encouraged to consult their own legal counsel and/or regulators within their member country or jurisdiction of origin.

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Wayne Webster

Good article. Skip at your own financial peril.

January 04, 2021 10:38

This is a well written article and should give medical device companies pause as they consider the potential for additional expenses and delays with these new rules. Unfortunately, most learn by failing and emptying their bank account. An economist several decades ago encapsulated the problem very well. He said, "Most organizations continue to implement solutions for problems they no longer have." In other words keep acting as if the EU hasn't changed and it will cost you dearly.

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