The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization process. In particular with regard to the European Union, Switzerland and United Kingdom, the current regulation views Switzerland and the UK as Third Countries, no longer covered by the mutual recognition through which they were considered within the EU.
This implies that as of now it is necessary to comply with the specific regulations in force in each of these 3 areas.
- In order to market their own devices in the European Union, Manufacturers based outside the area (including the UK and Switzerland) must appoint a European Authorised Representative.
- If the marketing is for Switzerland, Manufacturers based outside Switzerland must appoint a Swiss Authorised Representative.
- In order to place devices on the UK market, Manufacturers based outside the UK must appoint a UK Responsible Person (UKRP).
Here is some important detail information on the role of the three representatives:
*** European Authorised Representative [art. 11-12 MDR/IVDR]
Any Manufacturer, based outside the EU, must necessarily appoint through a written mandate an Authorised Representative located within the territory (European Authorised Representative) in order to market their own devices (of any risk class) in Europe, who will act on behalf of the Manufacturer with reference to the obligations set out by the regulation.
The Authorised Representative must designate at least one Person Responsible for Regulatory Compliance (PRRC) who has the responsibilities described in article 15 and is jointly and severally liable with the Manufacturer, in case the latter acts not in compliance with the obligations stated by the regulation.
The Authorised Representative also has the following responsibilities:
- ensure that the Technical File and CE Declaration of Conformity are available and apply the right procedure of compliance enforcement;
- keep a current copy of said documentation, together with the EU certificate when present, for the time that is set by the regulation;
- verify Manufacturer’s registration details on Eudamed;
- communicate with the Competent Authorities, act as required in case of adverse events and field corrective actions and comply with all post-market surveillance obligations;
- in case of termination of the agreement, notify the designated entities and proceed to transfer the necessary information.
As an Economic Operator the European Representative can be subjected to inspections, announced or not, from the Notified Body designed by the Manufacturer and from the Competent Authorities.
The Authorised Representative must be therefore very carefully selected, as appointing for this role a European distributor or an organization that do not have the processes needed to comply with the regulations is a high risk for the Manufacturer in the marketing of the devices.
*** Swiss Authorised Representative [Contingency MedDO]
The agreements currently under negotiation between Switzerland and the EU make reference to a number of bilateral arrangements, including the agreement to remove technical barriers to trade, known as Mutual Recognition Agreement (MRA).
The current Mutual Recognition Agreement (MRA) does not cover regulation on Medical Devices and IDV and Manufacturers based outside Switzerland wanting to place their devices on the Swiss market must appoint a Swiss Authorised Representative.
What are the obligations of the Swiss Authorised Representative?
- communicate with Swissmedic, act as required in case of adverse events and field corrective actions and comply with all post-market surveillance obligations;
- register the devices on the Swissmedic database within the prescribed time.
*** UK Responsible Person (UKRP) [guidance regulating Medical Devices in the UK]
At present in order to place devices on the UK market it is necessary to appoint a UKRP if the Manufacturer is based outside the area. The UKRP must designate at least one Person Responsible for Regulatory Compliance, who will ensure adherence to the regulatory requirements in force in the UK.
What are the obligations of the UKRP?
- communicate with MHRA, act as required in case of adverse events and field corrective actions and comply with all post-market surveillance obligations;
- register the devices on the MHRA database within the prescribed time;
- keep a copy of the Technical File as evidence of compliance with the requirements;
- check labelling requirements compliance.
How can Thema support you?
Thema is able to carry out the services of European Authorised Representative, Swiss Authorised Representative, and UKRP in full compliance with the local regulation.
Thema ensures compliance with the assigned obligations through an organization managed by processes according to the ISO 13485:2016 standard, adequate controls on the Manufacturer and the product as well as adequate insurance coverage to ensure device marketing compliant with mandatory regulatory requirements.
The services of European Authorised Representative, Swiss Authorised Representative and UKRP are just what you need?
Ask for our support at email@example.com