Brexit may have profound effects on the medtech sector causing concern for companies. For example, the CE marking process is dependant on mutual recognition among member states and with the UK leaving the EU, such regulations will be critical to ensure that a similar unilateral agreement is set up. If not, access to new devices will be delayed.
The CE mark is recognised by countries outside the EU: Norway, Iceland and Liechtenstein are covered as EEC signatories, whereas Switzerland has simply transposed the Medical Device Directives – the EU laws covering device regulation – into its national laws.
However it is unlikely that the UK will join the EEC due to the mandatory free movement requirement which was one of the driving factors for the UK leaving the EU. A more distant regulatory relationship is that between the EU and Australia. Australia recognises the CE mark to a limited degree: CE marked products must still be registered with the Australian Therapeutic Goods Administration, and there is a mandatory audit for certain classes of device, but the process is much easier than for non-CE marked products.