Demystifying the European Medical Device and In Vitro Diagnostic Regulation: A Must-Read Guide for Retailers Selling Medical Devices and/or In Vitro Diagnostics

For both product categories, the European Union has introduced new regulations, with extra obligations for operators in the supply chain distributing these products, to improve the safety and traceability of these products. How do these new regulation impact supermarkets, drugstores, or pharmacy organizations?

The European Medical Device Regulation (MDR) 2017/745 and the In Vitro Diagnostic Regulation (IVDR) 2017/746 address new and challenging obligations for Importers and Distributors that go beyond what retailers usually cover when buying, receiving, storing, and distributing their products. Retailers are considered Distributors according to these new regulations and could be considered Importers as well when buying products from outside the European market (a “third country”).

Note: as the obligations for retailers of medical devices and IVDs are similar, for the sake of simplicity of reading the remainder of this blog we will refer to MDR 2017/745 and can in all instances be replaced by IVDR 2017/746. Also,medical devices and in vitro diagnostics are collectively referenced as “medical devices”.

Some of the key ones include:

• Stricter rules. One of the major changes is that the rules for medical device safety and performance have become stricter. Retailers (Distributors) will have to verify that the medical devices they sell have evidence of compliance with the new requirements.
• Identification of Economic Operators. MDR 2017/745 requires the identification of all Economic Operators (including Distributors, Importers, Manufacturers, and Authorised Representatives) involved in the medical device supply chain.
• Traceability system. MDR 2017/745 calls for the establishment of a traceability system. A new barcode system based on a Unique Device identifier (UID) has been introduced. This UDI system will help to ensure that medical devices can be traced through the supply chain.
• EUDAMED. The European Database on Medical Devices (EUDAMED) is a new database that maintains information about medical devices marketed within Europe Union (EU). It aims to enhance transparency about medical devices, including better access to information for the public and healthcare professionals and enhancing coordination among EU member states.
• Notified Bodies. MDR 2017/745 introduces increasing surveillance of Notified Bodies. Notified Bodies are responsible for CE marking medical devices, necessary to allow these products to be placed on the European market.

How do these changes impact retailers?

Under the MDR 2017/745 retailers – when distributing medical devices – assume the Economic Operator (EO) role of Distributor. If retailers buy and import these products as the first (legal) entity in the EU directly from a third country such as China, the United States, or a non-EU member state such as Switzerland, they also assume the Economic Operator (EO) role of Importer.

Below are some key obligations described that retailers of medical devices need to be aware of, and obeying them is important to comply with the MDR 2017/745.

As a retailer assuming the Economic Operator role of Distributor:

• Verify registration of devices: You should verify that each medical device you sell has a registration in EUDAMED. However, the date when EUDAMED will be fully functional has been postponed and a new date has not yet been set. For the time being, you will have to obtain the relevant device registration evidence from the Manufacturer of the medical device or their European Authorised Representative in case of a medical device from a third country.
• Maintain documentation: You should maintain documents and records of the Manufacturers, medical device names or model numbers, Unique Device Identifiers (UDIs), and dates of sale. You should also maintain an administration of complaints received from the market regarding the medical devices you have sold. These complaints must be forwarded to the manufacturer without undue delay.
• Verify medical device safety and performance: You are also responsible for selling safe medical devices that perform as intended. If you have any safety concerns or have reasons to believe that the medical devices you are selling do not meet specifications, you must notify the Manufacturer of the medical device or their Authorised Representative who placed the medical device on the market, as well as the relevant Competent Authorities of the EU Member States. You should cooperate with the Competent Authorities on request. It is also expected that you will forward complaints immediately to the Manufacturer and other relevant Economic Operators in the supply chain.
• Verify labeling and packaging: You should verify that CE marking, Declaration of Conformity (DoC), labeling, and packaging of the medical devices correspond to the information contained in the Manufacturer's or Authorized Representative's CE marking application file. You should retain copies of CE certificates and DoCs. This implies that you should obtain this documentation from the Manufacturers of the medical devices or their Authorized Representatives.
• Maintain the supply chain: You should identify all Economic Operators involved in the supply chain – at least one level upstream and one level downstream – of the medical devices of concern to ensure that the medical devices you sell meet the requirements and keep traceability throughout the supply chain. In addition, you should verify if an Importer is identified as part of the labeling of the medical device in the case of selling medical devices from a Manufacturer based in a third country.
• Ensure transport and storage conditions. You should ensure that medical devices – while they are under your responsibility – are stored and transported under the conditions specified by the Manufacturer. This relates to medical devices in your stores as well as medical devices in your distribution centers. This implies that you should obtain and verify the transport and storage requirements from the Manufacturers of the medical devices.

As a retailer assuming the Economic Operator role Importer, similar obligations as for Distributor apply and in addition:

• Verify Manufacturer and Authorised Representative. You should verify that a Manufacturer is identified for the medical devices and an Authorised Representative is designated in case of medical devices imported from a third country.
• Ensure your company is listed as part of the labeling. You should ensure that your company is indicated on the medical device or its packaging, or in a document accompanying the medical device. It should list your company name, registered trade name, or registered trademark, your registered place of business, and the address at which you can be contacted.

For “Legacy Devices”, i.e. medical devices still covered by the European directives CE certificate and still placed on the market, the obligations of Distributor and Importer are limited[1]. Until 2028 we are still in transition between the previous directives and new regulations, and therefore it is key to understand if a medical device imported and/ or distributed by your company is already transitioned by the Manufacturer to the MDR 2017/745.

It is important to understand that the new obligations outlined in MDR 2017/745 have to be followed immediately. This regulation entered into force on May 25^th, 2017 and the date of application was May 26^th, 2021, which means that from that date onwards all Economic Operators must live up to their obligations.

What is the role of the ‘Blue Guide’?

The ‘Blue Guide’ (2) is a set of European Union product rules developed by the European Commission. Although it is not legally binding, it provides guidance on how to apply product rules and achieve compliance. The principles of the Blue Guide have been incorporated into the MDR 2017/745.

What to do?

If you have not already done yet, as a retailer of medical devices it is advised to take the following steps:

• Review your product portfolio. Review your product portfolio and identify all products that are classified as medical devices. Obtain information from the Manufacturers of these devices such as device classification, CE marking, Declaration of Conformity, CE certificates (if applicable), labeling, and country of origin of the Manufacturer. The name of the Manufacturer, country of origin, and CE mark is be listed on the medical device label and in other labeling.
• Identify your Economic Operator roles. Review your supply chain of medical devices and identify your Economic Operator role(s) under the MDR 2017/745. Identify other relevant Economic Operators in the supply chain such as Importers and Authorised Representatives for the medical devices supplied from a third country.
  

Figure 1: Simplified logical supply chain of medical devices showing the supply chain members and key Economic Operator roles.

• Implement processes and procedures. Implement processes and procedures for performing your obligations such as verification of devices, maintaining complaint records, ensuring storage and transport conditions, and reporting to Competent Authorities and other Economic operators. Although having a formal Quality Management System (QMS) is not a requirement from the regulations, doing without a QMS will make it complicated to consistently fulfill your obligations and obtain objective evidence that you are fulfilling your obligations. In addition, some EU Member States require that a formal QMS should be established. Therefore, we highly recommend looking into the regional regulations and laws in addition to MDR.  
• Execute and verify processes and procedures. Execute the processes and procedures and verify execution and records by, for instance, internal audits.

How can we help you?

Qserve can help you to identify the medical devices in your supply chain, identify your Economic Operator role(s) and associated obligations, and help you with the implementation of policies, processes, and procedures as part of a Quality Management System to comply with MDR 2017/745 obligations.

(2) 2022/C 247/01, The ‘Blue Guide’ on the implementation of EU product rules 2022