Which MDR requirements apply to distributors of medical devices?
Learn more about how the roles of medical device distributors are defined and which requirements they need to fulfil under EU MDR.
Replaces the previous version of 27.05.2019.
The new Medical Devices Regulation (EU MDR 2017/745) places greater onus on market players. For the first time, explicit regulatory requirements were introduced for distributors of medical devices, who now have increased responsibilities under the EU MDR.
Which general tasks and duties do distributors have to carry out according to the EU MDR and IVDR?
According to the EU MDR, ‘distributor means 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 into service’ (Article 2 (34)). This is important as stakeholders automatically become distributors as soon as they engage in any market activities and must meet a distributor’s duties.
General duties of distributors are outlined in Article 14 of the EU MDR. Distributors have a verifying and ensuring function under the EU MDR (and IVDR) with regard to the medical devices that they make available on the market. This includes the requirement for verification that medical devices are CE-marked and have a valid EU declaration of conformity. Also, distributors must ensure that instructions for use and labels are available in the required languages of the envisaged distribution countries (for more information see our blog post on MDR language requirements).
In the case of imported medical devices, it is also required to verify whether importers meet their obligations as outlined in EU MDR Article 13 (3). This means that distributors must verify that importers indicate their registered place of business on the devices or in the respective instructions for use and that an address is included at which importers may be contacted. Verification of assignment of UDIs, where applicable, is part of the distributor’s duties as well. With the verification, distributors accept co-responsibility, which also includes making sure the distributed products do indeed conform. Read more about Swiss medical device importers here.
With this, distributors themselves become ‘supervisory bodies’ on the medical device market. If distributors have reason to believe that a product does not fulfil EU MDR requirements, they must inform the manufacturer and, if applicable, the manufacturer’s representative as well as the importer. Furthermore, distributors are obliged to immediately inform the competent authority if they have reason to believe that a product was falsified and/or presents a serious risk to patients’ health. It is therefore not enough to not distribute such a product (sales ban) but instead the notification of the competent authority is compulsory.
If distributors come to learn about any incident regarding a product they make available on the market, they are obliged to immediately inform the manufacturer (or the importer and the representative in case of imported products). Of complaints, non-conforming devices as well as recalls and withdrawals, distributors shall keep a register. Distributors are thereby obliged to keep above-mentioned market stakeholders informed and provide any available information at their request.
Furthermore, distributors also have obligations regarding traceability under the EU MDR. According to Article 27 (8) they must store and keep UDIs of implantable class III devices they supplied or made available on the market. The European Commission may specify additional products, product categories or product groups to which these requirements apply by means of implementing acts.
The document MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 outlining duties of manufacturers and importers may be consulted to provide information about distributors’ requirements. Alternatively, we recommend our related blog article.
When do distributors have to assume manufacturers’ obligations?
EU MDR Article 16 specifies cases in which distributors must even assume the obligations of manufacturers. This is the case if distributors make devices available on the market under their own names, registered trade names or registered trades. Distributors may conclude agreements with manufacturers whereby manufacturers continue to be identified as such on the label and will remain responsible for meeting manufacturers’ obligations under the EU MDR.
If, however, a distributor changes the intended purpose of a device already placed on the market or put into service, he assumes the obligations of the manufacturer. This also applies if he modifies a device already placed on the market or put into service so it impacts the compliance with applicable requirements.
By assuming the obligations of the manufacturer, the distributor’s list of obligations grows considerably. Thus, it is important to know what distributors may or may not do without this rule coming into effect.
Which obligations do distributors have to assume if they modify devices?
It is not a change to the medical device’s intended purpose if a distributor provides the information on it according to Annex I Chapter 23. This includes necessary information for the identification of both the device and its manufacturer, as well as any information regarding safety and performance of the device relevant to users or any other person as appropriate. If the distributor provides additional information for the marketing of the device in the respective country it also does not constitute a change of the device’s intended purpose. It is also not the case if distributors provide this information in the form of a translation. When distributors make changes to the packaging or packaging size of devices, they also do not have to assume manufacturers’ obligations.
In both cases manufacturers are obliged, however; to declare such actions on the device or the document accompanying the device and to provide their contact details. Furthermore, the requirement of a quality management system is relevant in both aforementioned examples. For information regarding repackaging and relabelling please consult the document MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
The extent to which these requirements apply to devices certified under the MDD and making use of the EU MDR’s transitional provisions is discussed in the document MDCG 2021-25 Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC.
When do distributors of medical devices need to have a quality management system (QMS)?
In general, Article 14 of the EU MDR does not include any legal obligation for distributors to introduce a QMS. Nevertheless, the processes that all distributors must have in place in order to fulfil any relevant requirements under the EU MDR shall be thoroughly documented. This is where the recommendation to implement a QMS to all distributors originates from. A QMS ensures that only medical devices are distributed that achieve conformity and that non-compliant, faulty or unsuitable medical devices are identified, and that traceability is ensured.
However, the absence of any legal obligation for the introduction of a QMS only applies to distributors for as long as they do not make any changes to the medical device. If they, however, make the aforementioned changes and provide information or translations or make changes to packaging, distributors assume the responsibility for it and require a QMS, which they must have certified by a notified body.
According to EU MDR Article 16, a QMS shall ensure that any provided translation of information is up to date, that the changes made to the packaging do not have any impact on the original condition of the device and that the new packaging is of adequate quality.
Which requirements does the QMS have to fulfil?
To learn more about requirements for a distributor’s QMS, the document of the Medical Device Coordination Group may be consulted MDCG 2021-23 Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The document records that, in addition to above-mentioned processes, the QMS should also include contractual agreements to ensure conformity. This means that contracts with economic operators, from which the distributors purchase the devices, should ensure conformity and that distributors are informed in time about any corrective actions required to respond to safety issues or in order to achieve conformity of the device. In this context, the guidance even suggests that the contract between distributors and notified bodies should include the possibility for on-site audits at the premises of distributors or subcontractors.
Additionally, the MDCG document lists the areas that the QMS needs to cover in order to meet the requirements of EU MDR Article 16. For example, this includes the clear allocation of responsibility within the organisation, processes for taking corrective actions, processes to ensure traceability of devices as well as various control mechanisms.
Collaboration of distributors with other operators and retail customers
Under the EU MDR, the collaboration between manufacturers and distributors is intensified as distributors must consult relevant documents and are co-responsible for the documentation (e.g., instruction for use and labels in the respective country languages) to be in conformity with the law. Therefore, it is advisable that distributors and individual manufacturers agree on such matters by contract; for example, who pays translation fees for missing translated instructions for use or how fast such documents must be made available.
As distributors also take on a controlling function in case of imported devices and are obliged to circulate data, the two-way exchange will be much closer than it may have been the case under the MDD.
Furthermore, changed dynamics become also apparent at retail customer level. In particular hospitals are in the process of building up their knowledge about the more stringent EU MDR requirements and adjusting their processes accordingly. This is evident in the increasing number of enquiries regarding their delivery capacities. Customers are better informed about regulatory requirements today and more frequently confront distributors and manufacturers with such questions and requests. By providing the service of a Swiss Authorized Representative we have already been confronted regularly about this.
How Decomplix can help
If you have any questions regarding the role of the distributor under the EU MDR or need help establishing a QMS, our team of experts is at your disposal. Please do not hesitate to contact us.
Pictures: Zurjieta, William Potter, Aunging/Shutterstock.com