Regulation on Medical Devices 2017/745 (MDR): focus on medical device distributors

Differently from the current Directive 93/42/EEC concerning medical devices, adopted in Italy with Legislative Decree 24 February 1997, no. 46, the Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017 regarding medicinal products (hereafter MDR) introduces other figures beside the manufacturer and the European authorised representative. These figures include the distributor and the importer.

Up to May 2025 products certified according to the directives and those certified according to the regulation will coexist on the market. Both categories of products will enjoy equal status according to the regulations and they cannot be subject of any discrimination in the public tenders.

The role of distributor

A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service.

The responsibility of the distributor in the MDR is sensibly widened compared to the current directive.

Regarding post-marketing surveillance, the MDR obliges the distributor that received complaints or reports from health operators, patients or users on suspected incidents regarding a device available to them to promptly transmit the information to the manufacturer and, if necessary, also to the authorised representative and the importer. Concomitantly, the distributor is also bound to maintain a register of complaints, of non-compliant devices, as well as of recalls/withdrawals, keeping the manufacturer informed about such monitoring and providing him and/or the authorised representative and/or the importer with any information considered necessary.

Still on the topic of responsibility, distributors are bound to ensure that the storage and transport conditions comply with any conditions established by the manufacturer for the time period when the device is under their responsibility.

Based on the above, the distributor shall set up a series of procedures to manage the different activities.

These procedures shall be managed through a Quality Management System.

The requirements for a quality management system can be used in one or more phases of the life cycle of a medical device, including design and development, manufacturing, storage and distribution, installation, assistance as well as final disassembly and disposal of medical devices, and design and development or provision of any related activity (such as technical assistance) are reported in the international norm UNI EN ISO 13485.

The MDR provides for a clear definition of the distributor, and hugely widens his responsibilities compared to the current norms. Considering the bulk of requirements to be met, it is therefore desirable that distributors provide for a progressive program of compliance, to be implemented in different steps, including at least:

• Carrying out of thorough due diligences on manufacturers (especially those located outside the EU) to ensure that they have all technical and scientific information required to create a MD complying with the MDR;
• Legally binding agreements with manufacturers and any other business operators, not only to ensure a formal compliance with the MDR, but above all so that it is clear who is responsible for what and in which extent in the different steps of the life cycle of the MD;
• Setting up or update his own standard operational procedures and, more generally,
• Implementation of a quality management system to ensure the follow-up and suitability of the management according to the MDR.

With over 30 years of experience, Di Renzo Regulatory Affairs, can support the distributors in the setting up/adjustment of a Quality Management System according to the international norm UNI EN ISO 13485.

Written on 18/07/2019 by Felisiano Cipressi