As we edge nearer to a potential exit of the UK from EU on 29th March 2019 without the UK parliament having agreed to a deal with the EU, the probability of the UK leaving the EU without a deal grows ever greater. If this occurs, there will be no cushion of a transition period for medical device manufacturers.
Evasive action is necessary. We have drafted a short "to do" list in the form of a table to summarise actions that must be completed by 23.59 on 29 March 2019 in order for medical device companies to be able to continue to do business in EU27.
*If your legal manufacturer is in the UK, the EU27 AR will not be necessary on 29 March 2019 if the date for Brexit is extended or a transition period is agreed. Agreements with the AR you wish to appoint in this situation should therefore be conditional on the UK exiting the EU without an agreement for a transition period.
**Meaning of "placed on the market". This concept refers to each individual device, not the class of devices and the definition includes three essential elements (1 & 2 only if manufactured in the EEA, Turkey or Switzerland):
- The device is in the form in which it is offered to the public (including meeting all regulatory requirements); AND
- It has entered the distribution chain in the EEA, Turkey or Switzerland, which means that it has left the production process and is transferred for distribution with the intention of distribution or use in the EEA, Turkey or Switzerland; AND
- If the specific medical device is imported into the EEA, Turkey or Switzerland, if customs formalities have been completed, allowing the medical device onto the EU market for "free circulation".