This is a blog written by Elemed expert guest blogger Katarzyna Wesołowska. Want to be a guest blogger? Email karen@elemed.eu for more info!
Building an effective MDR strategy
The primary idea to be discussed here is to guide you through MDR provisions in a more practical way and help you to establish a proper cooperation with operators in the medical devices’ supply chain. Aim of the MDR is to force manufacturers to reconsider their supply chain and make all companies aware, what exactly their role is in the ‘placing on the market’ and ‘making available on the market” of medical devices.
Since the MDR’s date of publication I have been working with manufacturers, importers and distributors to build up an MDR implementation strategy and help them to develop appropriate measures to ensure compliance with the medical devices law. From my experience I have found that it is important to look at this issue from a more practical and technical way, rather than directly read regulations. In general, the type of activity, the type of medical devices manufactured, and the supply chain business model should be considered, when establishing the important rules of cooperation.
Primarily I will go through the general law provisions which appeared in the MDR regulation concerning economic operators. In the second instance I will consider required activities for authorised representatives, importers, distributors and link Quality Management Systems to these activities and lastly, I will provide some practical clues to the agreements between partners in the supply chain.
MDR’s principles for cooperation between manufacturers, authorised representatives, importers and distributors
Primarily, let’s focus on main regulatory provisions in the new MDR regulation [1]. Probably most of you have known it, so l will only summarize it.
A manufacturer, based in the EU or outside the EU, manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. An authorised representative, based in the EU, is assigned by the manufacturer by a written mandate to act on the manufacturer’s behalf in the EU. An importer, based in the EU, places a medical device from a third country manufacturer on the Union market. A distributor is different from an importer and makes a device available on the EU market.
Based on above information, manufacturers outside EU should appoint authorised representative, importers and distributors. manufacturers in the EU should only cooperate with distributors. The contract (mandate) in place is only required for cooperation with the authorised representative.
Authorised representative
This brings me onto practical issues on an authorised representative. MDR has provided several methods to increase obligations of the authorised representative.
Blue Guide [2] describes that delegation of an authorised representative should be set out in writing (agreement, mandate, or power of attorney) to define contents and limits of tasks. You should keep available the copy of the agreement for competent authorities upon request. According to MDR you as the manufacturer shall not delegate to the authorised representative any of the manufacturer’s obligations, mentioned in the Article 10 (design and manufacture, risk management, clinical evaluation, PMCF, technical documentation (TD), Declaration of Conformity, UDI, QMS, PMS, CAPA, FSCA, informative materials). However, it is not forbidden to obtain support in these issues from the authorised representative. The mandate should include the following authorised representative’s (AR) obligations and authorisations:
- AR should have access to the full TD, including information about the project,
- AR should be kept informed of any changes in legal regulations and should inform manufacturer of the changes in advance,
- AR should be able to represent a manufacturer adequately and answer all questions from competent authorities,
- AR is appointed in all information materials.
It is not specified, however Authorised Representative should be mentioned in your procedures about changes management. After each change in the DoC, project, or TD you should inform your representative to allow them to fulfil the MDR obligations and get the approval. This is your protection to prove that your devices are compliant.
Just a reminder, that an authorised representative could perform different roles from the regulatory perspective. If the authorised representative is also an importer, additional provisions should be added, or an additional contract should be signed. Additionally, PRRC cannot perform one function both for the manufacturer and the authorised representative.
Importers and Distributors
A lot of manufacturer’s partners are performing different roles in case of the MDR. It is necessary to define a role in each step of the product cycle. Moreover, under the MDR, the responsibility has covered importers and distributors as well. Thus, they should verify, withdraw, or recall it, if devices pose risk or do not comply with the requirements.
Importers, who have a direct contact with a non-EU manufacturer, should play an important role in placing products on the EU market according to the MDR. Thus, the verification process of each product should be established and maintained. First step of verification should be the verification by checking the documents (DoC, labels, IFU, certificates). The second step should be to check each individual medical device. In the MDR sampling is not allowed for importers, only for distributors. Therefore, batch certificates should be added by the manufacturer to each batch and shared with the importer. However, the importer should have a procedure in place to incidentally verify this process. The importer should keep records from the verification of documents and informative materials and inform the manufacturer about any defective device.
Distributors may have less options than importers to establish or change the agreements with the manufacturer because less contact with the manufacturer. The “Blue guide” [2] imposes distributors to check if the product bears CE marking, is accompanied by relevant documents e.g., DoC and by instructions for use and safety information in a language understood by consumers. The MDR repeats these obligations and forces distributors to implement in their day-to-day activities.
Quality management systems for importers and distributors
If you are an importer or distributor you do not need to have a full QMS in place, except the situation, when you relabel or repackage the final device (Article 16). Of course, it is useful to implement a QMS in your import or distribution company. Practically you should focus on the compliance of medical devices by implementing appropriate procedures to prove that:
- they are properly labelled, imported or distributed,
- non-compliant, defective or unsuitable medical devices can be detected,
- traceability is maintained.
It is better to have well-functioning procedures only for all above mentioned requirements rather than to have a full QMS documented in place without any further actions.
If you are a manufacturer, check with the importer and distributor the functioning of the following processes. If you are an importer or distributor verify if your processes are sufficient to confirm compliance with the MDR using below guidance.
Importers and distributors obligations
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Documented procedures in place for the supply chain processes:
- Traceability. You should know who has directly supplied your company with a device, to whom you have directly supplied a device and what health institution, or healthcare professional obtained a supplied device. CRM systems are very helpful in this case.
- Compliance verification. Establish how are you checking the conformity of delivered products in the scope of: CE marking, EU DoC, informative materials, information about the importer, UDI assignment. If you are a distributor, you can apply a sampling method that is representative of the devices using ISO standards [3]. In case of sampling, it is better for you to have a procedure for the sampling method and consider: batch or lot size, previous compliance problems and risk posed by each device.
- Transport and storage management. Establish how you receive information about storage and transport conditions from the manufacturer and how to maintain these conditions.
- Customer complaints, non-conforming products and recalls management. Determine:
- what to do after you have received complaints or reports from users or professionals,
- how to inform the manufacturer, authorised representative and importer about that.
- where to register of complaints, of non-conforming devices, recalls and withdrawals, reporting of adverse events.
- Cooperation with Competent Authorities and corrective actions. Describe:
* when you are obliged to cooperate with the competent authority to provide it with all the information and documentation to demonstrate the conformity of a device,
* how to contact the CA in case of serious risk. - Re-packaging or re-labelling of the device. Remember you should have a certified QMS for performing these tasks (certificate issue by a notified body), add the modification information to the label and inform about the activities the manufacturer and the competent authority. If you are not able to do that, I encourage you to delegate this the re-packaging and re-labelling to the manufacturer.
- Storage of UDI data – only for class III implantable devices. You should archive the UDI data of the devices.
- Registration the importer in the Eudamed. If you an importer you should also verify if the manufacturer or authorised representative have done the registration completely and without any mistakes,
- Registration in the national database for distributors. Only if the national law enforces all distributors to register. If you are a distributor you should check if it is applicable for you.
2
Controlled procedures (by title, issuance date and version) and change management for point 1. processes. When something changes in your organization’s procedures it should be well established and communicated to employees.
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- Personnel training. You should provide appropriate training and determine responsibilities of persons involved in the above-mentioned procedures.
Additional obligations of importers
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Contact details on the labelling. The main and most problematic issue for importers is the obligation to add own details (name, address and trademark) on labelling or the accompanying document. If you have not done it, you should provide resources to do that e.g., printing labelling, ensure that labels are affixed or sign an agreement with the manufacturer to perform it during the manufacturing process.
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- Verify device registration and add the importer details in the Eudamed.
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EU DoC and certificates. You should keep these documents for the period of 10 years or 15 years (implantable devices) after the last device has been placed on the market.
Proper Agreement with the partners in the supply chain
Ultimately, it appears that the important thing for manufacturers to keep in mind is to establish a mutual agreement with the responsibilities for each partner in the supply chain. It is not mandatory, however it can be useful to organize overlapping obligations between the partners, like reporting incidents, managing of nonconformities or cooperation with the competent authorities. You can avoid for example multiple reporting of suspected incidents and be sure that corrective action will be taken immediately by the right partner.
If you do not want to sign an extension agreement it should be only a short letter, statement or guide with the information, what do you expect from your partners in each situation. Of course, it is an obligation of importers, distributors and authorised representatives to fulfil the MDR’s obligations. However, they are dealing with different manufacturers and other partners, who have established some individual rules in the territory. Thus, roles and responsibilities of each partner should be detailed for clarity.
Conclusion
All things considered, cooperation between economic operators is a complex issue. Only a handful of companies have fully adapted their practices to the MDR requirements. The takeaway from this discussion might be to establish some rules at the beginning of the cooperation with economic operators or right now at the MDR implementation process, to avoid misunderstanding and serious problems in the future in case of serious events, recalls or traceability issues.
References
- Regulation (EU) 2017/745 of 5 April 2017 on medical devices.
- The ‘Blue Guide’ on the implementation of EU products rules (2016/C 272/01).
- ISO 2859 series of standards for sampling for inspection by attributes.
Katarzyna Wesołowska,
Chief Executive Officer at MDR Regulator
Katarzyna is a biomedical engineer by education, an auditor and consultant by trade, highly experienced in the medical devices field. Since the beginning of her career, she has been involved in the medical industry, working for both healthcare companies and a notified body as an implantable devices specialist and auditor. Since the date of MDR’s publication she has been supporting manufacturers in the implementation provisions of the regulation.
Sharing her experiences and helping others with their various projects is source of happiness for her. Katarzyna has become recognized for her practical and customised approach, adapted to a diverse range of cases and the entire life cycle of medical devices.
