Regulations relating to Medical Devices (MDR) and in-vitro diagnostic Medical Devices (IVDR), adopted on April 5, 2017, were published in the Official Journal of the European Union on May 25, 2017 – the starting date of the transition period.
As manufacturers shall use this transition period to update product and process documentation in order to meet the new requirements, also European Authorized Representatives shall be equally ready.
Below are described some topics of interest that may be applicable to Authorized Representatives responsibilities and fulfillments, from Brexit to the new applicable obligations.
Brexit: what are the consequences?
The situation is not yet completely clear, but it is possible to describe some consequences likely to happen:
- Any UK manufacturer or importer will no longer be perceived as an economic operator established within the EU.
- British distributors of Medical Devices/IVDs based in the EU will become importers of third countries products.
- British medical device manufacturers shall choose a European Authorized Representative in order to be able to continue placing their products on the European single market.
- Authorized Representatives established in the United Kingdom (currently around 50% of European Medical Device Authorized Representatives) will no longer be considered European Authorized Representatives and will therefore no longer be allowed to perform this role on behalf of non-EU manufacturers.
- Manufacturers and European Authorized Representatives shall henceforth have at least one qualified person responsible for regulatory compliance, based in the EU. The European Commission recommends that manufacturers established outside the EU “take the necessary measures to ensure that, as of the exit date [of the United Kingdom from the EU], the designated European Authorized Representatives or the persons responsible are established in the EU-27”.
The Authorized Representative responsibilities according to the MDR and the IVDR
The written mandate must be conferred by the foreign Manufacturer to the single Authorized Representative. The minimum requirements as outlined in the legislative texts must be clearly defined in the mandate. These requirements include having a person meeting the minimum qualification requirements similar to those applicable to the person responsible for regulatory compliance designated by the manufacturer (Responsible Person).
The Authorized Representative shall guarantee the compliance of the devices and act as main contact point based in the EU. Therefore, the Authorized Representative is responsible before the law of defective devices in the event that a manufacturer does not fulfill his obligations. Furthermore, the Regulations provide that the Authorized Representative must be held jointly responsible with the importer and the manufacturer for damage caused by defective products.
see also https://www.thema-med.com/en/role-responsible-person-new-regulations/
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