Judgment of the European Court of Justice of 16 February 2017:
For the EU, the authorized representatives of EU medical devices play a decisive role if the medical device manufacturer does not have a seat or branch office in the EU.
The authorized representative assumes the following duties as an obligation from the EU Medical Devices Regulation, in particular (no claim to completeness):
- Archiving of approval documents (10 or 15 years depending on risk class).
- Provide the technical information of the declaration of conformity.
- Issuing of approval documents (Including Supplements).
- Contact for unannounced audits, random sample Tests.
- Submit routine reports to the notified Body.
- Contact for importers, dealers, notified body, competent authority, service Provider.
- Joint and several liability claims (joint liability).
- Provision of a qualified Person (At least one person must have the necessary expertise in the field of medical products and regulatory questions. If the manufacturer has its head office outside the EU and no branch office is held, the authorized representative must have appropriate capacities.).
- Monitoring after the placing on the market of the medical device.
- Cooperation with the competent authorities.
- Promptly inform the manufacturer of complaints and problems with the users.
There shall be sufficient documentation from the manufacturer’s conformity procedure. This also includes the complete technical description and further documentation from the conformity procedure. This goes far beyond the current document availability, such as the confirmation of conformity.
The mandate of the authorized representative by the non-EU resident producer must be recorded in a written mandate. There are some regulations that are listed as a minimum requirement in the new Medical Device Directive. The authorized representative must accept the mandate in writing. The mandate must be valid at least for all products a generic group.
Thus, the authorized representative assumes a more formal role in the procedure of conformity as importers and dealers. The authorized representative is therefore the main economic operator for medical device manufacturers outside the EU. The competence of the respective national supervisory authorities is also determined by the company seat of the authorized representative.
Importers and Traders
But importers and traders are also faced with new challenges. The importer is subject to common liability as the manufacturer and the authorized representative. The importer is a medicinal product placed on the market in the EU market, manufactured by a non-EU medical device manufacturer. Importers must check whether the medical device bears the CE marking, the product is labeled according to the new regulation, or the required instructions for use are available. Importers must indicate their name, address, etc. on the product, its packaging or a document accompanying it. Importers must check whether the medical device is registered in the electronic system. Importers are subject to far-reaching reporting obligations.
The trader who supplies the product must verify the CE marking and the declaration of conformity issued for the medical device. The dealer must also check whether the imports have met their requirements.
If the importer or the trader is of the opinion that the medical device does not meet the requirements of the MDR, it must not be made available to the market.
Importer and trader can also obtain manufacturing characteristics if either an authorized representative in the EU has been appointed by the manufacturer or other product packaging or instructions for use (including translations) are produced.
Traders of medical devices should inquire about the path of conformity in the future. A much broader communication in the distribution chain, right up to the authorized representative of the manufacturer in the EU area, is also necessary.