The Medical Device Coordination Group (MDCG), an advisory body of the European Commission, has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to provide medical device manufacturers and other parties involved with recommendations regarding compliance with the applicable regulations in the context of MDR postponement.
Regulatory Background
The present MDCG guidance is addressed to manufacturers of Class I medical devices who intend to market their products within the European Union. The recommendations provided in the document could also be used by other parties involved in operations with medical devices including but not limited to importers, distributors, and authorized representatives of foreign medical device manufacturers intended to enter the EU market. The MDCG also emphasizes that the document does not constitute a definitive interpretation of the new Medical Devices Regulation 2017/745 (MDR) – the recommendations it contains are non-binding and not enforceable.
The MDCG states that the scope of the MDR is actually wider than it was before under the Medical Devices Directives superseded by the MDR since it covers medical device manufacturers and other entities participating in the supply chain. From the device-specific standpoint, the scope of the new regulation also covers products that are not medical devices but are intended to be used in the appropriate context (for example, for cleaning, disinfection, or sterilization of medical devices).
Medical Device Manufacturers` Obligations under the MDR
According to the MDR, in order to be allowed to market its medical device, the manufacturer shall:
- demonstrate conformity with the MDR and compliance with the applicable safety and performance requirements,
- affix the CE mark,
- submit the Declaration of Conformity.
To cover the aforementioned points, the manufacturer shall:
- Implement a quality management system and a risk management system,
- Perform a clinical evaluation,
- Perform a conformity assessment (in the case of sterile medical devices, ones with measuring functions or reusable surgical instruments a Notified Body should be involved),
- Prepare technical documentation to be provided upon request,
- Prepare an EU Declaration of Conformity,
- Register as an entity in the electronic system (Eudamed) and obtain a Single Registration Number (SRN) to be used in further communications,
- Register the device in question in the Eudamed system and assign the Basic UDI-DI.
- Assign the UDI to the device itself and its packaging so the UDI can be used to identify and track the device during its lifecycle.
- Supply the device together with the information allowing to identify the manufacturer. The information accompanying the device should also cover the most important safety and performance aspects and should be provided in the official languages of the European Union (depending on the particular Member State where the medical device in question would be marketed).
- Establish a proper post-market surveillance system corresponding to the class of medical device under the risk-based classification (as an integral part of the quality management system).
- Establish an efficient incident reporting system. In particular, the manufacturer shall keep records related to any adverse events occurred when using the device, and also to implement the safety and corrective actions aimed at mitigation of the negative consequences caused by the medical device and restore compliance with the applicable requirements.
- Maintain sufficient financial coverage related to the potential liability (depending on the class of the device and its type, and also on the size of the entity).
If medical devices are to be supplied sterile, medical devices with measuring functions, or reusable surgical instruments, the manufacturer shall also engage a Notified Body (NB) to perform a conformity assessment. It is important to mention that the particular medical device in question should fall within the scope of the designation of the Notified Body in order for the NB to be eligible to carry out such a conformity assessment.
Big and mid-size medical device manufacturers shall also duly appoint at least one person responsible for regulatory compliance, while for micro and small entities it would be sufficient to have such a person at their disposal.
If the manufacturer is registered outside the European Union, it is also necessary to appoint an authorized representative residing in the EU. In particular, a foreign manufacturer shall issue a mandate describing the powers and responsibilities of the representative. It is also important to mention that certain obligations related to the medical device could not be delegated.
The manufacturer shall duly keep all the documentation used to confirm compliance with the applicable requirements to provide it to the regulating authority upon request.
Placing Class I Medical Devices on the EU Market
The present MDCG guidance describes the procedure to be fulfilled by the medical device manufacturer when placing its device on the European market. The whole procedure includes a set of mandatory steps, namely:
- MDR integration in the Quality Management System (QMS). The requirements set forth under the MDR should be properly integrated into the QMS established by the manufacturer.
- Confirmation that the product in question is a medical device and thus should be regulated under the MDR. The determination should be made on the basis of intended medicinal purposes indicated by the manufacturer. It is important to mention that the accessories to the medical devices are also covered by the scope of the MDR despite not being medical devices themselves.
- Confirmation that the medical device subject to review is a Class I medical device. The initial classification should be performed by the medical device manufacturer. However, if there are any doubts, the final determination should be made by the regulating authority. If due to its features the device in question falls under the scope of several classification rules, the one with the highest class should be applied.
- Procedures to be performed before marketing the device (implementation of the risk management system, clinical evaluation, preparation of technical documentation, instructions for use and labeling, and requesting the Notified Body involvement – if applicable).
- Checking compliance with the general obligations for manufactures (including the strategy for regulatory compliance).
- Drawing-up the EU Declaration of Conformity. The Declaration shall contain all the information on the medical device in question as required under the MDR and shall be available to the competent authority.
- Affixing the CE marking which indicates that the medical device complies with the applicable safety and performance requirements and is allowed to be marketed in the EU. For the devices requiring the involvement of a Notified Body, the CE marking should be accompanied by the number of the Notified Body that performed the conformity assessment.
- Registering the medical device itself and its manufacturer in Eudamed.
For medical devices already placed on the market under the Directives, a simplified approach could be applied, providing that the manufacturer will analyze the gap and ensure that all requirements set forth under the Regulations are duly fulfilled.
Summarizing the information provided hereinabove, the MDCG guidance describes the way Class I medical devices should be placed on the EU market. The scope of the guidance also covers sterile medical devices (Class Is), devices with measuring functions (Class Im), and also reusable surgical instruments (Class Ir) – the types of medical devices requiring a Notified Body to be involved in pre-marketing procedures.
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