The Medical Device Coordination Group (MDCG), the advisory body of the European Commission, is composed of the representatives of all EU Member states and is entitled to provide clarification regarding the implementation of the EU medical device legislation. They announced the issuance of new guidance dedicated to specific aspects of Class I medical device regulation.
The Scope Of The Guidance
The new guidance issued by the MDCG is intended to assist medical device manufacturers in maintaining compliance with the requirements set forth by the Regulation 2017/745 (MDR). At the same time, the document also partially covers the obligations of other parties involved, such as authorized representatives, importers and distributors. First of all, the document describes the main principles introduced by the new Regulation:
- A life-cycle approach to safety aspects – according to the MDR, compliance with the safety requirements should be maintained during the whole lifecycle of the devices. This includes all steps, from design and manufacturing to distributing and utilization by patients, users or healthcare professionals.
- Data-backed approach – all claims and statements regarding the safety, effectiveness, and performance of the device when used for the intended purpose should be confirmed with the clinical data collected properly in accordance with all of the applicable requirements of clinical trials,
- Transparency and traceability – the utilization of a unique device identifier, a special security element, that allows the tracking of the particular medical device at all steps from manufacturing to providing the product to the end-user to counteract the distribution of the counterfeit medical devices.
Obligations Of The Manufacturer
To be able to place the device on the EU market, the manufacturer must confirm compliance with safety and performance requirements set forth by the applicable regulations, submit the declaration of conformity, and place a CE mark on the device and its packaging. The guidance also provides an extended list of responsibilities of the manufacturer related to placing the device on the market. These responsibilities include the following:
- Implement both quality and risk management systems on all steps of the manufacturing process,
- Perform clinical investigations,
- Perform the conformity assessment procedure (it is important to mention that in some cases it would be necessary to engage a designated notified body – for example, in the case of medical devices with measuring functions, sterile or reusable medical devices),
- Prepare technical documentation and the declaration of conformity,
- Upload all the information related to the medical device to Eudamed – the EU database containing information on all devices available on the EU market,
- Obtain the unique device identifier (UDI) ID and the Single Registration Number (SRN) and place the UDI on the device or its packaging,
- Provide the information necessary to use the device in a safe and effective manner (such information should be provided in one of the EU official languages together with the device),
- Develop and implement the post-marketing surveillance system including adverse events reporting and field safety corrective actions, which are special measures taken by the manufacturer in response to the safety issues identified during the use of the device,
- Ensure that the financial coverage provided is sufficient to cover all potential expenses that could arise due to the liability of the manufacturer.
It is also important to mention that medium and large medical device manufacturers are required to appoint a special person responsible for all compliance issues. Foreign manufacturers based outside the EU should also designate an authorized representative responsible for all communications with regulating authorities during the whole life-cycle of the device, including the obligation to provide all information related to the device upon the request. Such a representative would be also responsible for transmitting inquiries submitted by users to the manufacturer.
Requirements In Detail
The guidance provides detailed information on all of the steps medical device manufacturers should take in order to be allowed to place the device on the market. These steps, among others, include:
- To implement the requirements set forth by the MDR into the existing quality management system to ensure compliance with applicable regulations.
- To check whether the device meets the definition of a medical device, which depends on its intended purpose. If the manufacturer claims several intended purposes, all appropriate frameworks would be applicable.
- To check whether the device should be classified as a Class I medical device depending on the intended purpose and the risk associated with the use of the device. It is important to mention that if several risk categories are applicable, the highest one should be applied.
- To implement the risk management system to identify potential hazards and risks associated with the device, and to control and manage such risk.
- To perform a clinical evaluation to obtain clinical evidence to confirm compliance with the applicable requirements related to safety and performance. Clinical evaluation should be held and documented strictly in accordance with the requirements set forth by the MDR to ensure that results are accurate and suitable for assessment purposes.
- To provide technical documentation for the device, which contains information regarding classification, detailed descriptions of the device including its variations and accessories, the information accompanying the device (such as labeling or user instructions) and manufacturing information. Technical documentation should also include the results of pre-clinical and clinical evaluation. All the aforementioned information should be provided in a clear and structured manner in one of the EU official languages.
- To engage the notified body if required due to the specific features of the device. In some cases, the manufacturer should communicate with the appropriate notified body chosen from the list of designated notified bodies depending on its codes indicating the scope of designation. For example, if the device subject to review should be manufactured in sterile conditions, the manufacturer should address the inquiry to the notified body specially designated to manage the specific issues in question.
- To draw the Declaration of Conformity to gain compliance with all applicable safety and performance requirements. The manufacturer would have to keep the declaration up-to-date and amend it if any changes are made to the device or the manufacturing process.
- To place the CE mark on the device itself or on its packaging as well as on the instructions for use. CE marking should be clearly visible so that any person would be able to easily identify it. In the case of the notified body involvement in the assessment process, the code of such notified body should be placed nearby.
- To register the device in the Eudamed, the EU database storing the information on all medical devices.
- To develop and follow post-marketing surveillance procedures necessary to compile user experience and implement the necessary corrective actions.
According to the guidance, if the particular device is already on the market under the Medical Device Directive (the current EU medical device regulation that will be replaced by the MDR), the manufacturer should perform the gap analysis to check the compliance with the latest requirements provided by the MDR.
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