Medical devices and application for exemption
In case of a no-deal Brexit
The UK has decided to leave the EU including the single market and the customs union. Consequently, the trading conditions between the UK and Denmark will change.
If the UK leaves the EU without any collaboration or trade agreements with the EU, the UK will be considered as a third country.
The Danish Medicines Agency has produced an FAQ with questions and answers related to medical devices marketed in Denmark in case of a no-deal Brexit.
To manufacturers of medical devices
Notified bodies from the UK cannot perform assessments of conformity after a no-deal Brexit
Manufacturers of medical devices in medium- and high-risk classes must perform an assessment of conformity with the involvement of a notified body in the EU/EEA. The notified body issues a certificate to the manufacturer if the manufacturer and the device fulfil the requirements of the medical devices legislation. Hereafter, the manufacturer can affix the CE marking to its device, and it can be marketed across the EU/EEA.
The manufacturer must use a notified body that fulfils all the requirements for notified bodies appearing from the medical devices legislation to maintain certification.
The four British notified bodies certifying medical devices can no longer perform assessments of conformity if the UK leaves the EU without a deal (no-deal Brexit).
Permission to market a non-CE marked medical device after a no-deal Brexit
The Danish Medicines Agency may, if health concerns speak in favour thereof, in special circumstances permit the marketing and use of a non-CE marked medical device.
Legal basis for exemption
The legal basis for giving such permission is found in section 6(12) of executive order no. 1263 of 15 December 2008 on medical devices, section 5(8) of executive order no. 1264 of 15 December 2008 on active implantable medical devices, and section 6(11) of executive order no. 1269 of 12 December 2005 on in vitro diagnostic medical devices.
These rules transpose the provisions of the medical devices directives. Reference is made to article 11(13) of the medical devices directive, article 9(9) of the directive on active implantable medical devices, and article 9(12) of the directive on in vitro diagnostic medical devices.
- The Danish Medicines Agency can issue a time-limited authorisation in the event of a supply shortage caused by a no-deal Brexit and Danish hospitals/healthcare professionals state that the device is necessary for the treatment of patients, or
- The Danish Medicines Agency can issue a time-limited authorisation until the manufacturer has had its authorisation for a new certificate processed by a notified body within the EU/EEA.
Manufacturers can apply for an authorisation by completing and submitting an application for exemption.
Instructions to fill out the application for exemption
The application form has two parts:
- The manufacturer fills out the first page of the application form and then obtains a statement from a hospital/healthcare professional
- The hospital/healthcare professional fills out the next page of the form, stating why the device is necessary in patient treatment, including the underlying health concerns and indicates whether there are alternative CE-marked devices on the market
- The manufacturer submits the entire application to the Danish Medicines Agency.
Before seeking authorisation, the Danish Medicines Agency recommends manufacturers to engage in dialogue with its UK notified body to get a status on their certificates in the event of a no-deal Brexit. If certificates are transferred to a notified body in the EU/EEA in time before a no-deal Brexit, there is no need to apply for an exemption.
Any decisions about exemptions will not be made until after a no-deal Brexit, the reason being that certificates from UK notified bodies will remain valid as long as the UK is still part of the EU.
The application should be sent to firstname.lastname@example.org
Guidance from the European Commission:
The European Commission has published a number of guidelines and interpretation documents in connection with Brexit: