What kind of responsibility has a European authorised representative of medical devices?
The response is in the text of Regulation 2017/745 EU, applied as of 26 May 2021.
Differently from what has happened for distributors and importers, the role of the authorised representative was already defined in Directive 93/42/EEC and in its national implementing text, Leg. Dec. 24 February 1997, no. 46.
The level of responsibility of the authorised representative on legal issues caused or related to medical devices of extra-EU manufacturers according to the Directive was not particularly detailed. Actually, the only responsibility of the authorised representative was expressed in art. 18(a).
At national level, on the other hand, Leg. Dec. 24 February 1997 – the Italian implementation of Dir. 93/42/EEC – was already strict regarding the responsibility of the authorised representative. This can be seen with reference to the obligations and sanctions present in Articles 7(1) and (3), 9(7), 17(6) and (8), 18(2), 23, at least for the sections (1) and (8).
The current approach depending on the Member State is currently superseded by Reg. 2017/745 EU on medical devices (MDR). Differently from the Directives, in fact, the Regulation has not required any national implementation; it follows that article 11 on the responsibilities and obligations of the authorised representatives is already fully applicable. Member States need only to comply by defining the national sanctions, as provided for by art. 113.
It is evident that Art. 11 of the Regulation regulates more specifically the role of the authorised representative, providing for the obligations of document control, documentation storage and more generally, attributing an actual controlling function on the activities carried out by the manufacturers to ensure the conformity of the device, including the obligations of the registration and UDI system. The authorised representative is also bound to act as intermediary with the manufacturer, if required, to face the requests of the competent authorities.
Regulation 2017/745 EU also clarifies that, without prejudice to section 4 of article 11, in case the EU manufacturer has not complied with the obligations provided for section 10, the authorised representative is legally responsible for defective medical devices as much as the manufacturer.
A similar role to the authorised representative has been recently adopted also in extra-EU countries, i.e. United Kingdom and Switzerland.
In the United Kingdom, the “UK Responsible person” is a subject established in the UK representing the manufacturer. This role was introduced by the United Kingdom following post-Brexit adjustments, in particular with S.I. 2019/791 amending MDR 2002. For UKCA-marked medical devices, the information regarding the UK Responsible person shall be reported in the label.
On the other hand, Switzerland – after the failure in the renewal of the mutual recognition agreement with the European Union – has introduced the obligation of introducing a CH-Rep, a representative of the MD manufacturer established in the Swiss territory, according to the definition of the Medical Device Ordinance; SR 812.213. MDs marketed in Switzerland shall report the CH-Rep and the relevant information in the label, although periods to adjust have been provided for, depending on the medical device risk class.
Like the European authorised representative for extra EU manufacturers, these two roles are essential for the marketing of medical devices in the UK and Switzerland, respectively. Manufacturers of medical devices interested in these markets are therefore called to implement the required organisational adjustments.
Written by: Riccardo Del Signore