What requirements must a product fulfill before it can ultimately be sold in the EU? This question is answered in the second chapter of the Medical Device Regulation (MDR). It includes information on placing products on the market, commissioning, and the role of authorized representatives. The responsibility for this lies with manufacturers, importers, and distributors.
This article will deal with the duties of these groups of persons. It explains what Authorized representatives are and why a EU declaration of conformity is necessary. As might be thought, the duties of manufacturers, importers and distributors do not end with the product’s sale, but also require some resources afterwards.
Responsibilities of manufacturers
Manufacturers must ensure that the products they produce comply with the requirements of the MDR. For this, three processes are necessary. The establishment of a quality management system is expected to secure, for instance, the regulatory compliance strategy, general safety and performance requirements, and post-market surveillance. When using a risk management system, the entire life cycle of the product should be documented. This entails regularly updates and risk assessment on an ongoing basis. Finally, depending on the product’s risk classification, a clinical evaluation is required. Subsequently, a systematic process for collecting and analyzing clinical data should be implemented.
Duties of Importers and Distributors
The duties of importers and distributors, have some overlap. According to MDR, , both need to ensure a CE markings on their medical devices and the availability of an EU declaration of conformity certificate. Furthermore, they are responsible for labeling products in accordance with the MDR. Two other important aspects, which relate only to importers, are the electronic registration of articles and the assignment of Unique Device Identifiers (UDIs). Importers and distributors have the obligation, similar to manufacturers, to cooperate with the competent authorities and to notify latter ones about possible defects in their products. However, as soon as distributors or importers change the name of a product or its intended use, they take over the obligations of manufacturers.
For manufacturers outside the EU, it is necessary to appoint an authorized representative to continue to distribute products in the EU. With the nomination the authorized representative is required to carry out the tasks assigned by the manufacturer him-/herself. This includes, among other things, checking the completeness of declarations of conformity and the technical documentation. The authorized representative must also report to the manufacturer any problem that occurs with a product distributed by them on the European market. It should also be noted that in their capacity as a representative for the European market, they are just as liable as the manufacturer.
EU Declaration of Conformity
Since it is part of the manufacturer’s obligations, the EU declaration of conformity is part of the market entry consideration. It states that the respective product complies with the requirements of the MDR. The information it contains includes:
- Registered trade name of the manufacturer
- Basic UDI-DI
- Risk class
- Reference for identification (e.g., product or trade name)
- Place and date of issuance of the Declaration of Conformity, including signature
Finally, by issuing the EU Declaration of Conformity, manufacturers assume responsibility for their product.
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