A new notice from the European Commission lays out how Brexit will impact economic operators including medical device companies, Authorised Representatives and Notified Bodies.
In Jan 2018 the European Commission published a notice that identified medical device companies, authorised representatives and NBs that will be affected by Brexit. Many of these impacts would be only in a “worst case” scenario for example, if no mutual recognition agreement is reached, which at this point in time is unlikely. Testing this theory are the Brussels negotiators pushing a “no deal” concept.
Brexit and Authorised Representatives (AR)
British manufactures will need an EU based AR, manufactures placing devices onto the EU market can only do so if the firm is based in the EU or they have an EU AR. Some sources speculate the UK will be treated like a third Country.
Importers and distributors
Following this same vein the UK will therefore no longer be able to be used by third countries as importers for the EU. If the distribution network isn’t evaluated and modified UK distributors will instead be considered importers. UK NBs can’t be used for the EU and new NBs will need to be appointed for your products.
Void CE Certificates
CE certificates for EU regulations can only be issued by Notified Bodies based within the EU. This means that all certificates issued by UK-based Notified Bodies will become void after 29 March 2019. After that date British Notified Body can no longer issue CE Certificates for the EU.
UK-based manufacturers will need an AR, just like any non-EU manufacturer. They will have to create a distribution network with an AR/importer.
Problems with distribution networks effected downstream from UK operators will be an opportunity for EU based organisations.
Smaller UK device companies may have device availability effected.
New non UK based NBs will need to be found.
Possibly those most likely hit are British patients.
They will face the prospect of manufacturers that cannot reach the UK market as easily as they do now. Any-UK based manufacturer may incur additional costs for placing devices on the European market, which will be reflected in their product prices.
Emergo, Jan 2018
If you wish to discuss how Instem can support your company through Brexit please reach out to our team with your needs, [email protected] or +1244857900.