The European has adopted yesterday a Communication to help national authorities, businesses and citizens prepare for the inevitable changes that will arise at the end of the transition period of the EU and UK in the Brexit separation process. Changes will occur to cross-border exchanges between the EU and the UK as of 1 January 2021– irrespective of whether an agreement on a future partnership has been concluded or not.
Yesterday's Communication “Getting ready for changes” sets out a sector-by-sector overview of the main areas where there will be changes regardless of the outcome of the ongoing EU-UK negotiations, and sets out measures that national authorities, businesses and citizens should take in order to be ready for these changes. It does not examine the possible implications of a failure to reach an agreement, nor does it consider the need for contingency measures.
The communication is high level, but helpful sector specific readiness notices have been provided in addition. For medical devices and IVDs, several of the guidelines are relevant.
Most notably the basic guidance on all CE marked products, indicated as “Industrial Products”. The guidance explains the essence of the situation and the underlying market approvals (CE certificates), and continues in the annexes to explain the allowance on further distribution of products that were brought into the market inside the EU or in the UK. It explores the need to transfer information between a UK Body and an EU Notified Body. And finally it sets out some clarifications on the applicable rules in Northern Ireland after the end of the transition period. The guidance includes several examples of product placement before 31 December 2020, such as a cosmetic product, a circular saw and an X-ray device. As CE marking is general in its rules, all examples bear relevance to the device and IVD industry.
A second guidance of interest to our industry is that on clinical trials. It details elements such as the supply of investigational products, the sponsor, responsible person etc. Focusing on pharmaceuticals, it is mostly relevant for combination products ruled under the pharma legislation (MDR art.117), an potentially companion diagnostics as studies on these are typically done in conjunction with a study on the respective drug. But also some of the concept might be applied to running clinical trials on medical devices and performance evaluation trials on IVDs.
More relevant guidelines could include those on air transport, E-commerce, E-signatures, Excise duties, GLP, medicinal products (relevant for combination products), online purchasing with subsequent parcel delivery, prohibitions and restrictions of imports/exports, incl. import/export licences, substances of human origin (a.o. blood, tissues and cells – relevant to MDR and IVDR), trademark and designs, VAT on goods and VAT on services, to name just a few.
The website concludes with a caution: If the European Union and the United Kingdom fail to reach an agreement by 31 December 2020, the changes at the end of the transition period would be even more far-reaching.
Undoubtedly, in such unwanted situation, the European Commission and the UK government will be providing further detailed guidance as relevant.
Qserve continues to closely monitor the situation in respect to Brexit and local agent services
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