Key points on medical devices for pharma – MDR and Brexit

Key takeaways from this Pharma forum 2021 session include:

-MDR is fully in force, including in Northern Ireland for the foreseeable future.

-CE marked products are accepted in GB on a discretionary basis until 30 June 2023; watch out for the new regulations governing the UK CA mark regime.

-Even if you have certificates subject to transitional provisions, there are many MDR provisions that must be complied with now (for example, economic operator obligations and PMS).

-If you're selling combination products (drugs and devices), be aware of the greater complexity of MDR for getting the device part through this new regulatory regime.

-Be aware of the different registration requirements in Great Britain, Northern Ireland and the EU.

-Appoint a UK Responsible Person for GB (if you haven't already done so).

-Dual marking (CE and UKCA) will be permitted in the UK if the requirements of both regimes are met, including labelling requirements.