After the UK formally left the European Union (EU) on January 31, 2020, a number of questions remained regarding the impact on businesses selling products in the European Economic Area (EEA). To avoid business disruptions, the EU and UK have agreed to a one year transition period between the UK’s formal departure from the EU and the separation coming into effect. However, with the EU Medical Device Regulation (MDR) (2017/745) and In-Vitro Diagnostic Regulation (IVDR) (2017/746) set to come into effect in the next two years at the time of this blog’s publication, the impact on medical device companies will be particularly important. During this time, medical device companies hoping to maintain EEA access will have to prepare to comply with the EU’s regulations as foreign bodies to the EU.
Preparing for the EU Medical Device Regulation
The EU Medical Device Regulation is currently scheduled to come into effect in May 2020, which puts it firmly in the middle of the Brexit transition period. Companies within the UK will still be in scope when the EU MDR comes into effect, however, the EU IVDR does not come into effect until 2022. This means British companies operating within the UK will not be affected by the EU IVDR, though it is important for companies to be prepared to comply with similar regulations in the UK, given British officials’ stance on adopting regulations equivalent to those in the EU.
Certifying Products with EU Notified Bodies
During the Brexit transition period, British officials have stated the UK will be flexible in its acceptance of EU-certified products as they finalize British equivalents of EU regulations such as EU MDR and EU IVDR, but the EU will not be making exceptions for UK-certified products. The EU will be holding firm on the requirements to do business in the EEA, including certification by EU-27 notified bodies.
As companies can only attain certification with an EU-27 notified body if they have an office in Europe, this creates new complications for UK companies hoping to maintain EU market access. British companies that do not have a European office will have to register in the EU before they are able to certify or recertify their products with an EU-27 notified body.
Maintaining Access to the European Economic Area
Companies preparing to address EU MDR and IVDR requirements in order to maintain European market access will have to start preparing now by identifying ways to gain access to an EU-27 notified body. Further, they will have to re-evaluate all the regulations they have previously reported for, and determine whether they must recertify before Brexit comes into effect. Once companies have identified in-scope products requiring recertification and prepared their European presence, the product certification process will begin.
This challenge also extends beyond the EU MDR and IVDR; companies operating in the EU will also have to ensure they are still compliant with the Restriction, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation, the Restriction of Hazardous Substances (RoHS) Directive, and the Waste Framework Directive’s Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database.
Because the EU MDR and EU IVDR are new regulations, companies may be going through the process of certifying their products for the first time, however, due to the volume of products that will require certification — and recertification — companies will have to devote adequate time and resources to these complex processes when Brexit is fully enacted.
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