Ireland is already a leading location for pharmaceutical and medical technology companies and is, therefore, a natural hub for businesses in this area who wish to expand their presence in the EU-27 remaining member states in preparation for Brexit. Regulatory authorisations will also need to be reviewed.
On 10 January 2018, the European Commission published an important notice warning concerning CE marking on industrial products, which will be relevant for companies in the medical devices sector. The notice advises CE mark holders to take steps to ensure that post-Brexit, where applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body. Where economic operators hold certificates issued by a UK Notified Body prior to the Brexit withdrawal date and plan to continue placing the product concerned on the EU-27 market, the notice advises that they consider either applying for a new certificate issued by an EU- 27 Notified Body or arranging for a transfer of the file and corresponding certificate from the UK Notified Body to an EU-27 Notified Body.
With regard to pharmaceutical products, the European Commission has published a Notice (latest version dated 29 January 2018) and practical guidance for Marketing Authorisation Holders (MAHs) on procedures related to Brexit, including procedures for transfer of marketing authorisations from UK based MAHs to MAHs based in the EU-27.
See our full Brexit Special Report here