May 26, 2020 | European Regulations


Quality Management System is a requirement not only for Legal Manufacturers

The EU Medical Device Regulation (MDR) brings a lot of new requirements along. The impact of these requirements affects not only the manufacturers but also all other players in the medical device industry from the Legal Manufacturers to the Own Brand Labelers, and not to forget importers, distributors and of course notified bodies. In this article we are going to talk about one of the so called economic operators – the distributor. This particular group of actors in the medical device industry have to deal with a load of new requirements.

Did you know there are times when the MDR requires the distributor to have a certified Quality Management System (QMS) even when the distributor is not required to assume the obligations of the manufacturer? Probably not.

Surprisingly for the distributor, the MDR requires a distributor that translates the manufacturers’ IFU or repackages the device to follow certain rules, including the requirement for a QMS.

Per MDR Article 16 (2,3,4) if the distributor carries out the activities listed in paragraph 2, then paragraphs 3 and 4 apply.

Summary of Article 16 (2) distributor activities:

  • Provision and translation of (i) manufacturer’s label and instructions for use and (ii) any information necessary to market the device in the Member State (MS)
  • Repackaging necessary to market the device in the MS (condition of the device cannot be affected)

Summary of Article 16 (3,4) distributor obligations:

  • Distributor to have a QMS in place to allow (i) Accurate and up-to-date translation of information, (ii) Preservation of the original condition of the device and quality of re-packaging, and (iii) Answering to safety issues and taking corrective actions
  • Distributor to indicate on the device (or packaging or accompanying document): (i) Activity carried out, (ii) Name, (iii) Registered trade name or trade mark, (iv) Registered place of business and (v) Contact address
  • 28 days prior to making the relabeled or repackaged device available on the market: distributors to (i) Inform manufacturer and competent authority (+ provide mock-ups) and (ii) Submit NB certificate attesting that the QMS is compliant

It is interesting to note that the scope of ISO 13485:2016 was explicitly clarified to allow it to be used by all organizations involved in the product life-cycle of a medical device, including distributors. If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined not to be applicable, the organization records the justification as described in 4.2.2.

Therefore, any distributor conducting the previously stated activities should start planning on how they will address the new QMS requirement of the MDR, or maybe they should request the manufacturer provide correct translations or product packaging.

Those distributors who are conducting the above-mentioned activities and do not have a certified QMS in place, will need to implement, certify and maintain a QMS to be able to fulfil the MDR requirements. In this case, it is worthwhile to consider that the MDR poses challenges to the notified bodies as well, who must provide appropriate resources, update their procedures, and work for a certain period of time according to MDD and MDR at the same time. These challenges will have a direct impact on the number of notified bodies accredited for the MDR which is expected to decrease to less than the half of the number of notified bodies accredited for the MDD. This could create a long queue of distributors and manufacturers waiting for their turn to have their QMS audited and certified.

About the authors:

Donald J Alexander BSEE, JD

Don has been in the medical device industry for over 35 years serving in numerous Product Development, Quality Management and Regulatory Affairs roles, such as product development engineer, engineering manager, VP RA, and VP QMRA. Currently he is Director Global Quality System Support for a medium sized medical device manufacturer.

Angelina Hakim, M.Sc. in Biomedical Engineering

Angelina is founder and managing director of QUNIQUE Ltd. She has more than 12 years’ experience in the medical device industry covering a wide spectrum of medical device technologies including endoscopes, implants and defibrillators. Currently she works as a senior consultant on Quality Management and Project Management topics and gives seminars and trainings on behalf of notified bodies and training institutes.

PDF: MDR Economic Operators August

PDF: MDR_June 2017