How medical device distributors remain compliant under the EU MDR
The MDR replaces the regulatory framework that was in place for almost three decades, introducing explicit regulatory requirements a distributor of medical devices has to meet. But would it surprise you to learn that the new obligations introduced by the MDR are based on the system that was already in place? And with regards to the quality management system of a distributor, that it is best to start with the processes already in place to ensure compliance with MDR?
A few months ago, we wrote about the regulatory requirements of distributors under the MDR, in a post which describes how the Medical Device Regulation (MDR (EU) 2017/745) introduces significant requirements for economic operators of the entire supply chain of medical devices, including distributors.
While our previous post focused on the newly introduced regulatory obligations from a legal view, this post intends to give distributors an idea on where to start in order to use the time before the date of application of the MDR in May 2021 to become compliant. Even though the MDR includes a sell-off provision that allows products in compliance with the Directives that have already been placed on the market to be made available, distributors will have to meet the obligations outlined in Article 14 of the MDR as of 26 May 2021.
Do medical device distributors need a quality management system (QMS) to be compliant with the MDR?
This is the most frequent question we receive. And the problem with the answer is that, even if the MDR does not require distributors to have a QMS, every distributor needs to have a look at the processes in place to ensure MDR compliance.
But let’s start from the beginning. In general, Article 14 does not provide a legal obligation for distributors to implement a QMS, if he does not make country-specific adjustments to a medical device (such as repackaging or providing and translating the legally required information as outlined in MDR Annex I, section 23 on label and instructions for use). In the latter case the distributor assumes responsibility for the changes of a medical device and does not only need a QMS but also have it certified by a notified body (MDR Article 16).
However, it is widely recommended to implement a QMS (which Decomplix can help you with), as the processes that have to be in place in order to fulfil the relevant obligations of the MDR have to be documented. A QMS provides assurance that only medical devices in compliance with legislative requirements are distributed, that non-compliant, defective or unsuitable medical devices can be detected, and that traceability is maintained.
Documented processes are fundamental when it comes to preparing for new regulatory requirements and to account for the fulfilment of such requirements. But we would like to argue that some of the requirements are not that new after all, and this is good news.
What regulatory requirements were in place before the MDR?
No explicit obligations for distributors were included in the three medical device directives that were implemented in the 1990s when the EU started to regulate medical devices. But that does not mean that distributors did not have an important role to play within the framework of regulatory compliance since then.
Additional provisions for economic operators were introduced in 2008 in the New Legislative Framework (NLF) consisting of Regulation (EC) No 765/2008, Decision No 768/2008/EC and the Blue Guide, and were integrated in recent transpositions of medical device legislation in most EU Member States.
- Regulation (EC) No 765/2008 sets out the requirements for accreditation and market surveillance relating to the marketing of products and includes definitions of distributors and economic operators very similar to the MDR.
- Decision No 768/2008/EC on a common framework for the marketing of products introduces the requirement for all economic operators intervening in the supply and distribution chain to “take appropriate measures to ensure that they make available on the market only products which are in conformity with the applicable legislation. This Decision provides a clear and proportionate distribution of obligations which correspond to the role of each operator in the supply and distribution process.”
- The ‘Blue Guide’ is a guidance document on the implementation of the EU products rules, explaining the provisions for economic operators that are required for a comprehensive regulatory framework that ensures the safety and compliance of industrial products. The Blue Guide already mandates specific obligations to distributors, for example to verify the following requirements before making a product available:
- that the product bears the required conformity marking(s) (e.g. CE marking),
- that the product is accompanied by the relevant documents (e.g. EU declaration of conformity) and by instructions and safety information in a language which can be easily understood by consumers and other end-users if required by the applicable legislation,
- that the manufacturer and importer have indicated their (1) name, (2) registered trade name or trademark and (3) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation, and that the product bears a type, batch or serial number or other element allowing the identification of the product.
This does not sound that different to the obligations of the MDR, in fact, the MDR largely implements the recommendations of the Blue Guide, which have been in place since 2008. The following obligations from the Blue Guide are also very similar to the ones imposed by the MDR:
- where a distributor modifies a product or markets it under its own name, it becomes the equivalent of the manufacturer and must take on the latter’s responsibilities in relation to the product;
- distributors must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation. Further, they must cooperate with the competent authority in actions taken to avoid or minimise these risks, inform the manufacturer or the importer as well as the competent national authorities;
- the distributor must also have a basic knowledge of the legal requirements.
This is not an exhaustive list, but should illustrate that not everything changes and at least some of the process requirements have been in place for a while, meaning distributors do not have to start from scratch, and that a QMS is not that far away.
From theory to practice:
How to start when you don’t know where to start
It is important to understand that quality and regulatory compliance (even without a formal QMS) are the responsibility of the organisation’s top management. It is essential that the organisation’s top management is involved and provides or organizes adequate resources to ensure regulatory compliance.
So whether you decide to implement a QMS, as recommended, or merely to adapt your processes to the MDR without a QMS, the first step consists of a gap analysis. According to the guidance document provided by the Irish Authority (HPRA), processes for operations which may affect the performance of the medical devices should be in place, such as:
- documentation control
- approval of suppliers and customers
- order processing and deliveries
- waste management
- change control
- quality risk management
- management of field safety corrective actions/recalls
- non-conformance management
- corrective and preventive actions
Requirements checklist for medical device distributors:
- Do you have documented procedures in place for your activities relative to medical devices? If so, are they controlled by title, reference, version number, issue date?
- Do you have documented procedures for any of the following processes: device traceability, device re-packaging and/or re-labelling, device installation, device servicing (e.g. maintenance, repair), non-conforming products, customer complaints, adverse event reporting, product recalls?
- Do you have agreements in place with the device manufacturers that describe regulatory compliance duties and their ownership?
Personnel and staff training
- Is there a person with appropriate training and experience appointed to ensure that regulatory responsibilities are met and that the required processes are implemented, controlled and effective?
- Is there a training plan in place? Are staff training sessions documented and recorded?
- Does the training include device compliance verification, device traceability, reporting of non-compliances, product recall/withdrawal procedures, and customer complaint procedures?
- Is there sufficient competent personnel to carry out all the tasks?
Labelling, handling of devices
- Are all products clearly recognizable as commercial products from an identified manufacturer?
- Do you repackage the products or exchange any components thereof (e.g. country-specific socket/cable)?
- Do you change existing labels or instructions for use, incl. opening the packaging to do so (e.g. additional label with number according to own ERP system)?
- Do all products already have the necessary instructions for use when received at your premises?
- Have you ever translated any label or instructions for use independently or in agreement with the original manufacturer?
- Do you install products at the customer’s site?
- Do you provide maintenance service or repair work?
- Do you have an emergency service department?
- Do you provide services in the area of reprocessing?
Customer Complaints and Product Recalls
- Is there a technical agreement in place between your organization and the manufacturer that specifies the responsibilities relating to the handling of customer complaints, adverse events/incidents, and product recalls?
- Are complaints immediately forwarded to the manufacturer (and where applicable, his authorised representative and/or the EU importer)?
- Are complaints technically analysed in-house? If so, are they categorised into quality, technical/service, vigilance or distribution related complaints?
- Do you have a register for complaints, non-conforming products, and product recalls and withdrawals?
- Do you have a procedure in place describing the process to be followed for customer complaints, adverse event or incident reports, and recalls (or other Field Safety Corrective Actions)?
- Does the procedure include how decisions/actions taken as a result of a complaint are justified and recorded?
If you have other questions regarding how to ensure compliance with MDR, our team of experts is always ready to help. Feel free to contact us here.
Pictures: Tuan_Aziz, Dominik Michalek/Shutterstock