What distributors need to know about the Medical Device Regulation (MDR)
Distributors are important market players in the chain between the manufacturer and patients. However, up to now there have been no concrete specifications regarding their tasks and obligations at the European level. The implementation of the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostics Regulation (IVDR (EU) 2017/746) changes this.
In the Medical Device Regulation, not only are the various economic operators defined (Art. 2 (34) MDR), distributor’s tasks and duties are also explicitly formulated for the first time (Art. 14 MDR). Nevertheless, there is still a need for clarification in this respect. Bibiana Gamper, Senior Regulatory & Vigilance Manager at ISS AG, answers our questions:
What are the tasks and obligations distributors have under the new regulations (MDR / IVDR)?
Distributors now have to verify that the medical devices they sell meet the defined requirements as outlined in Art. 14 of the MDR. Among other things, distributors must check whether the medical devices are CE-marked and have a valid declaration of conformity. Also they must ensure that the instructions for use and labels of the products are available in the official language of the countries in which the product is sold. In the case of imported medical devices, it must also be checked whether the importer fulfils his requirements as defined in Art. 3 of the MDR. This means that the distributor assumes part of the responsibility for the conformity of the products he sells. In case a distributor has reason to believe that a device is not in conformity with the requirements of the new regulation, he is not allowed to put the devices on the market.
Another rather interesting element of the Medical Device Regulation is that the outlined verification obligations make distributors some sort of “controlling authority”. Under the MDR and IVDR, distributors are obliged to inform the authorities if they suspect that the product is falsified or poses a serious risk. So it is not enough not to sell the product, a notification to the authorities is inevitable.
In addition, the distributor should keep a register of complaints, of non-conforming devices and of recalls and withdrawals.
Do distributors need a certified QMS?
In order to meet the requirements of the new regulations, it is recommended that distributors implement a Quality Management System (QMS). In the medical device industry, ISO 13485 is used in particular, but certification according to ISO 9001 could also be an option for a distributor. A certified QMS is not an obligation for distributors as formulated in the Medical Device Regulation, but it could be a competitive advantage, since customers (especially hospitals) evaluate their suppliers and an existing QMS certificate could strengthen trust.
According to Art. 14 of the MDR, there is therefore no obligation for a dealer to be certified according to ISO 13485. Nevertheless, it is my recommendation to implement a QMS which is ideally based on this standard. The situation is different if the distributor makes country-specific adjustments to a medical device already on the market, in particular the translation of the instructions for use and other documents, as well as changes to the packaging. The distributor assumes responsibility for these changes and must have his QMS certified by a Notified Body. He also has to notify the national competent authority of the respective country and the original manufacturer in advance of the adapted products.
How will the cooperation between manufacturers and distributors or distributors and end customers (such as hospitals) change as a result of the new regulations?
The cooperation between manufacturer and distributor will certainly be intensified, as the distributor has to verify certain documents and is jointly responsible that the documentation (e.g. instructions for use and label in the required national languages) is compliant. It is advisable for distributors to define these points contractually with the individual manufacturers so that, for example, it is regulated who bears the translation costs in the case of missing translations of the instructions for use or also how quickly these are made available.
End customers, in particular hospitals, must build up their knowledge of the stricter requirements that MDR / IVDR entails and prepare themselves accordingly. This is particularly evident in the fact that distributors are increasingly receiving enquiries regarding the availability of products. This means that today’s customers are also better informed about regulatory requirements and will certainly continue to confront distributors and manufacturers directly with such questions or demand proof of compliance with the regulations in the future.
This is a positive development, as the MDR divides the responsibility among the different market players and the obligation to actively inform themselves about the legal requirements applies to everyone. The Medical Device Regulation will also lead to more work in this area and it makes sense to prepare for more intensive cooperation and communication with all parties involved.
What is the timeline to fulfil the obligations according to the MDR or IVDR?
Regulation (EU) 2017/745 on medical devices will apply from 26 May 2020, Regulation (EU) 2017/746 on in vitro diagnostic medical devices from 26 May 2022.
This means that distributors of medical devices will have to comply with the new obligations from 26 May 2020. If distributors only sell in vitro diagnostic medical devices, the deadline will be 26 May 2022.
With the date of application of the new regulations, distributors will have to carry out a number of concrete tasks and obligations, and it will become apparent which implementation problems in this area will need further clarification.
What if a manufacturer does not have a valid MDR certificate for its product after 26 May 2020? And what does this mean for distributors?
Certificates issued by Notified Bodies in accordance with the Directives generally remain valid until the date indicated in the certificate or until 27 May 2024 at the latest, whichever is earlier.
It is, therefore, possible that after 26 May 2020 a manufacturer will still have a valid certificate according to the Directives and he may continue to place his products on the market.
In these cases, it is important for distributors to know how long a manufacturer’s certificate remains valid in order to be able to estimate until when the manufacturer will be able to sell his products. At the latest when the certificate expires, the manufacturer should have an MDR certificate. In the worst case, there is an interruption between the expiry of the existing certificate under the Directive and the receipt of the new certificate under the MDR, during which time the manufacturer may not place any products on the market.
Again, distributors and manufacturers need to communicate with each other as early and openly as possible in order to ensure supplies to customers.
Until when can medical devices that are compliant under the current Directives (AIMD, MDD, IVDD) continue to be marketed?
MDR and IVDR have integrated a sell-off provision into the legislation. This provision is intended to limit the period during which products that comply with the Directives and have already been placed on the market may be made available.
All products that are still in the supply chain and have not reached their end users (e.g. a hospital) on 27 May 2025 will no longer be marketable from that date and will have to be withdrawn from the market.
This means that as of 27 May 2025, distributors will no longer be allowed to sell medical devices certified under the MDD. It is, therefore, advisable to plan this period exactly and to prepare this step with the manufacturers and to specify the responsibilities in the contract. The same deadline applies to distributors of in vitro diagnostics.
I would like to use the following example to illustrate what this means:
Product XY was produced and certified under the MDD at the end of 2019 and placed on the market. The product has a shelf life of 10 years (expiry date 2029). If this product is still in stock at the distributor on 27 May 2025, it may no longer be distributed. Although the product still has a valid shelf life, it may no longer be sold as it does not meet the requirements of the MDR. However, if the product is in stock at the end user (e.g. hospital) on 27 May 2025, it may be used until the expiry date.
Where can distributors find more information about their obligations under the Medical Device Regulation?
The list of obligations can be found in Art. 14 of the MDR, which is the binding basis for the legal obligations of distributors. It contains all the specific obligations as well as a general duty of care/due diligence.
In addition, the European Commission has published a factsheet for importers and distributors, which summarises the obligations well. Also, there are publications by various European competent authorities on this subject. In my opinion, the publication of the Irish Authority (HPRA) is particularly worth reading.
Pictures: Zurjieta, William Potter, Aunging/Shutterstock.com