The European Union requires any foreign manufacturer from outside of the European union who intends to place their devices in any of the Member States to designate an authorised representative (EC REP) with a physical address within one of the Member States.
Under MDR and the IVDR, the EU Authorised Representative has more responsibilities than previously under the Directives. As per Article 11 of the MDR, the manufacturer and the EU Authorised Representative should agree the specific tasks in a mandate which the EU Authorised Representative will undertake on behalf of the manufacturer.
Under the Medical Device Regulation and In-Vitro Diagnostic Regulation, the EU Authorised Representative will include the following responsibilities:
Verify that the manufacturer’s device has undergone the appropriate conformity assessment;
Ensure that the Declaration of Conformity and the technical documentation has been completed;
Keep a copy of the Declaration of Conformity and the technical documentation along with a copy of the device certificate including supplements and amendments for a suitable time;
Ensure that the details of the manufacturer, EU Authorised Representative, importer and distributor are uploaded to an electronic system and kept up to date;
Provide Competent Authorities with any information or documentation required to demonstrate that the device meets conformity;
Forward any requests to the manufacturer from the Competent Authorities for sample devices;
Cooperate with Competent Authorities on any corrective or preventative actions;
Immediately inform the manufacturer of any complaints or complaints related to their devices;
Terminate their mandate as EU Authorised Representative if the manufacturer acts contrary to the MDR.
What impact has Brexit on the operations of medical device and in-vitro diagnostic companies?
From 1st January 2021, all UK based manufacturers who place their devices on the market in the European Union must contractually engage an EU Authorised Representative so as to keep their devices on the EU market. This is a mandatory requirement because on this date the United Kingdom will become a third country and therefore, outside Europe. It is also a mandatory requirement that the details of the EU Authorised Representative must be listed on the device label.
Med-Di-Dia can support UK companies keeping their devices on the EU market.
For more information see our post for UK companies at: