June 29, 2016
We would like to reassure our customers that UL remains committed to being a Notified Body and will continue to deliver a CE marking service to meet your needs for EU market access.
The options that will be available to UK notified bodies following the EU referendum in the UK will be determined following exit negotiations once Article 50 has been initiated. Notwithstanding, UL will have a solution and will continue to be your notified body.
Here is what we know today:
- There will be a 2-year transition period
- Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be our competent authority in the UK and we will work with them to find a solution
- All CE certificates and UKAS accreditations remain valid.
Regardless whether the final model adopted by the UK to co-operate with Europe is based around the Norwegian model which uses EEA recognition or the Switzerland model which uses Mutual Recognition Agreements to enable Notified Bodies to operate within the EU legislation or any other solution, UL will continue to provide clear communication as the situation unfolds to ensure that our customers have continued access to the market in the EEA for medical devices and IVDs.