European Commission Says Majority of Drugs, Devices Compliant Ahead of Postponed Brexit
Posted 11 April 2019 | By
Just before the European Council decided, in agreement with the UK, to postpone Brexit until 31 October, the European Commission offered an optimistic report on Wednesday on the preparedness of the drug and medical device sectors.
“Based on available information, the majority of medical products concerned by the UK withdrawal should be compliant with EU legislation on the withdrawal date,” the commission said.
Still, the commission noted that some medicines and medical devices may not be compliant in time and could be at risk of shortages if they do not act swiftly to remedy the situation. “The Commission and Member States will continue to monitor closely the progress of ongoing preparedness actions and provide support to affected stakeholders,” an annex published Wednesday says.
The commission also points out how Member States can use certain exemptions in the directives on human and veterinary medicines “to allow marketing authorisation holders to rely on
quality control testing performed in the United Kingdom for a limited period of time.”
For medical devices, the situation is different because neither the EC nor Member States are part of the Brexit preparation process. But the commission and Member States have been closely monitoring the progress of the transfers of certificates from UK notified bodies to EU notified bodies.
And the commission has issued guidance to the Member States on existing national derogations in the Directives on Medical Devices and In-vitro Diagnostics Medical Devices.
“These derogations may allow Member States, in duly justified cases, to authorise UK certificate holders to continue placing their products on the market in the territory of the Member State concerned for a limited period of time,” the EC says.
The commission also said it’s working with the Medical Device Coordination Group and the Competent Authority for Medical Devices network to monitor the progress of certificate transfers and identify critical medical devices that may be at risk of shortages. “In particular, the Commission will coordinate a transparent and coherent use of the national derogations by Member States across the EU to avoid any fragmentation of the Single Market,” the annex says.
A coordinated approach is also being undertaken to track and assess the possibility of medicine shortages.
European Commission Annex