MDR Factsheet For Distributors

This factsheet is aimed at DTR Medical distributors of medical devices within the European Union.

The new Medical Devices regulation (EU) 2017/745 (MDR) brings EU legislation into line with technical advances, changes in the medical science, and progress in law making.

The aim of the new regulations is to ‘create a robust, transparent, and sustainable regulatory framework, recognised internationally, which improves clinical safety and creates fair market access for manufacturers.’

Roles and Responsibilities of Distributors

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

The Regulations describe the roles and responsibilities of distributors, who should make sure by representative sampling, that the devices they distribute are compliant with the obligations described in MDR article 14.

Distributors should verify that;

  • The devices have been CE marked,
  • That an EU Declaration of Conformity (DoC) has been drawn up,
  • That labels and instructions for use are provided in the official languages of the member states (or in languages accepted by said state) in which the device is made available, if applicable.
  • Distributors should also verify that the importers name is indicated on each device or in the accompanying documentation, and that the device bears a UDI at all relevant packaging levels.

Distributors shall ensure that storage and transports conditions, when under their responsibility, are appropriate and in line with recommendations of the manufacturer.

What should you be doing?

As a distributor you should start thinking about how you are going to meet some of your obligations set out in MDR Article 14.

  • Have you practiced recording traceability data?
  • Are your complaints information in an easily traceable and searchable ‘register’?
  • Do you have an employee with the requisite skill to read and assess some of the due diligence requirements as defined within the regulations?
  • Can you prove in the event of a concern that your storage and transport provisions were acceptable for a specific product?
  • Do you know how to implement a sampling method in line with the requirements?

Distributors should also read and review MDR Article 16 to ensure they are not complicit/in breach of any of the special provisions discussed therein.

What are DTR Medical doing?

DTR Medical have applied for a certificate extension up to 27 May 2024, which is currently under review. This will allow continued sale of existing MDD compliant devices up until this date. Simultaneously DTR Medical have started actioning toward MDR compliance before this date and will keep all customers updated with progression and new certificates etc.

All DTR medical devices are already UDI compliant and are ready to progress on this as and when required. UDI compliant data sets are available and can be shared upon request.

DTR Medical will be looking to roll out new distribution agreements by May 2020 to meet the new regulation requirements.

Expect to hear from us with an updated agreement.

If you have any questions please do not hesitate to get in contact. We are more than happy to assist.



For more information on the Medical Device Regulation (MDR), please read below



 Introduction to the MDR

The MDR will replace the existing Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR was published in May 2017, initiating a three-year transition period. For medical devices the transition period will end on 26 May 2020.

During this period of transition, the Regulation will come into application gradually, starting with the provisions related to designation of Notified Bodies and the ability of manufacturers to apply for new certificates under the Regulations.

To minimise market disruption and allow a smooth transition from the Directives to Regulations, several transitional provisions are in place. Some Devices with certificates issued under the directives may continue to be placed on the market until 27 May 2024 and made available until 27 May 2025.

In contrast to Directives, Regulations are directly applicable and do not require transposition to national law. The MDR will therefore reduce risk of discrepancies in interpretation across the EU Market.


Until May 2025, products certified under the Directives and products certified under the Regulations will coexist on the market. Both will have equal status under the legislation and no discrimination in public tenders may take place.

A transition period is needed as the new Regulations require designation of Notified Bodies. This is the process whereby competent authorities will complete a joint assessment to assess a Notified Body for compliance. The designation process for Notified Bodies, which may take 18 months or more, involves assessors from both national and European competent authorities. This means that the first Notified Bodies designated under the new regulations were not established until the end of 2018/beginning of 2019. DTR Medical’s notified Body, BSI, were the first to be awarded compliance. For further details of NB designation and scope can be found on the NANDO list.

In addition, Manufacturers need to meet more stringent criteria, particularly in terms of clinical and performance evaluations, which requires a greater scrutiny from the Notified Body, which in turn increased the likely review timescales.

What has changed?

In general, the MDR retains all the requirements of the Directive while adding some new requirements of its own. Compared to the current directive, the new regulation has an emphasis on a life-cycle approach to safety, backed up by clinical data with a greater emphasis on proactive market data gathering. For national competent authorities and the commission, they add more control and monitoring requirements. The regulations clarify the obligations of manufacturers, Authorised Representatives, importers and distributors. Ars, Importers and Distributors formally having no ‘legal’ obligations within the directive.

The MDR reclassifies certain devices and has a wider scope than the directives. It introduces an additional pre-market consultation procedure for certain high-risk medical devices. The Regulations aim to increase transparency, requiring the publication of information on devices and on clinical and performance studies related to their conformity. The new European Database for Medical Devices – EUDAMED – will play a central role in making data available and increasing both the quantity and quality of data (MDR article 33).

Unique Device Identifiers (UDIs)

An entirely new requirement of the Regulations is the system of UDIs (MDR article 27). This will enhance the identification and traceability of devices through the whole supply chain. Better data at the point of use should improve patient safety.

The UDI will allow all stakeholders to access basic information on devices through the EUDAMED. The UDI will be placed on each packaging level of a device so each packaging level can be uniquely identified. The implementation for application of the UDI has been gated in stages for differing risk classes. Some devices may not be required to bear a UDI on 27th May 2024. See MDR article 123(3)(f) and (3)(g) for specifics.


A greater emphasis is given on supply chain visibility; king the Regulations are now very forward supply focussed, insisting on responsibility for all economic operators, both ‘backward’ and ‘forward’. Distributors and Importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. They must keep the UDIs for Class III implantables, preferably by electronic means. The obligation to keep UDIs for these devices also applies to health institutions, and member states have the power to extend this obligation on health institutions to other devices as well.


The new EUDAMED database will include information on UDIs, the registration of economic operators (except for distributors) and devices, certificates, clinical and performance investigations, post-market surveillance, vigilance and market surveillance (MDR article 33).

The database will be also used by manufacturers to report incidents, and as a platform for EU/EEA authorities to cooperate and exchange information. The information on the database will be uploaded by, and accessible to, everyone (incl. the general public), at levels depending on their access rights and the information they are responsible for uploading.

If a distributor considers a device to be non-compliant with the Regulations, the device shall not be made available to the market. In this case, the distributor should inform the other economic operator. Distributors should inform the authorities if they suspect a device has ben falsified or that there is a serious risk to health.

They should also keep a register of complaints, non-conforming devices, recalls and withdrawals.

Distributors shall be prepared to cooperate with authorities and make available all the documentation and information they have at their disposal.

The date of application (DoA)

Certificates remain valid until the end of the period indicated on the certification, or until May 2024, whichever is earlier. After May 2024 certificates will become void. Products can be placed on the market after May 2020 if covered by existing certificates. Any devices within the supply chain on 27 May 2024 will remain marketable and accessible to the end user until 27 May 2025. Any devices that are still within the supply chain and that have not reached their final user i.e. hospital, on 27 May 2025 are no longer marketable and must be withdrawn.

If you have any questions please do not hesitate to get in contact. We are more than happy to assist.