Medical Device Regulation, MDR, EU Regulation 2017/745, distributor obligations, medical device distributors, European Union, EUDAMED, economic operator, supply chain, UDI, Unique Device Identifier, technical documentation, medical device conformity, manufacturer obligations, distributor responsibilities, post-market surveillance, traceability, Class III implantable devices, regulatory compliance, medical device safety, European database on medical devices, Article 16, Article 27, Article 25, Annex II, medical device traceability, distributor definition, regulatory framework, MDR regulation, EU medical device law, medical device legislation, distributor liability, manufacturer liability, device modification, regulatory conformity, medical device life cycle, post-commercialization obligations
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Abstract
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Abstract
This document summarizes the European regulatory framework for medical device distributors under EU Regulation 2017/745, outlining their definition, obligations, and responsibilities.
Extract
[...] Notable differences exist between the distributor and other economic operators. Unlike the importer, the distributor does not directly source from a manufacturer established outside the EU. In fact, the importer (article 2.33) places a device on the European market for the first time by transporting it from the third country where it was produced. In contrast, the distributor procures devices from manufacturers or importers already established on the European market. Unlike the manufacturer (article 2.30), the distributor does not intervene in the production process of medical devices. [...]
[...] It responds to their requests for information or access to its documentation within the framework of periodic checks on compliance with the regulation. The distributor also provides its assistance to the community vigilance system. It transmits without delay to the authorities the reports received from healthcare professionals concerning an incident related to a medical device. This cooperation enables the authorities to effectively carry out their surveillance and public health protection missions throughout the life cycle of the devices. Finally, the distributor must respect the confidentiality of the information it has knowledge of in the context of its activities (Article 109). [...]
[...] What is the European regulatory framework resulting from the MDR applicable to medical device distributors? Distributors play a major role in making medical devices available to healthcare professionals and patients on a daily basis. They ensure the link between medical device manufacturers and healthcare establishments users. However, the regulation applicable to medical device distributors was only poorly defined in Directives 90/385/EEC and 93/42/EEC, leaving some ambiguities as to their obligations. The EU Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017, known as the 'MDR' (Medical Device Regulation), comes to specify in more detail the status and responsibilities of medical device distributors in the European Union. [...]
[...] Beyond these punctual obligations, the distributor is subject to permanent constraints due to its continuous responsibilities towards the medical devices it distributes. The European regulation on medical devices (MDR) was initially due to come into force on 26 May 2020. However, taking into account the difficulties encountered by operators to comply with the deadlines, particularly due to the health crisis, its entry into force date was postponed by one year, to 26 May 2021. But despite this postponement, the industry still encountered difficulties in certifying their existing devices according to the new regulatory framework of the MDR before the deadline. [...]
[...] Status of the Distributor 1. Regulatory Definition The concept of distributor is defined precisely in point 34 of article 2 of regulation 2017/745 relating to medical devices. This defines the distributor as any physical or legal person, other than the manufacturer or importer, who is part of the supply chain and makes a medical device available on the market up to the stage of its effective in-service use by the end-user. In concrete terms, the role of the distributor consists of ensuring the delivery of medical devices from the manufacturer or importer to the various points of sale or healthcare establishments where they will be used. [...]
