Medical Device Conformity Assessment Before its Placing on the EU Market
Before placing a medical device on the EU market, manufacturers are required to carry out a conformity assessment in accordance with Regulation (EU) No 2017/745 of the European Parliament and of the Council on medical devices, as amended (the "MDR") and subsequently issue a declaration of conformity. Manufacturers have the primary responsibility for ensuring that the product placed on the EU market demonstrates all the requirements under the MDR and other relevant legislation and technical regulations.
In addition, the MDR requires the involvement of a notified body for classes Is, Im, Ir, IIa, IIb and III medical devices conformity assessment. The task of the notified body is to verify and declare, in accordance with the relevant conformity assessment procedures set out in Annexes IX, X and XI of the MDR, that the manufacturer’s quality management system, the product technical documentation and parameters and manufacturing procedures conform with the MDR and other required legislative and technical provisions, where applicable.
In case of a positive result of the assessment the notified body shall issue the relevant certificate. After that, the manufacturer may draw up the EU declaration of conformity and place the CE marking of conformity as a declaration of compliance with all the requirements set out in the MDR and other relevant harmonised regulations.
New Regulation MDR and Old Directive MDD Relation
The Medical Device Regulation (MDR) replaces the previous Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). It is important for manufacturers to familiarise themselves with the requirements of the new Regulation as soon as possible and to make early plans for a successful transition and its implementation into their QMS.
Changes in the MDR are often considered as a mere revision of the original requirements, but this is not accurate. Although the conformity assessment methodology is based on the same foundations as it was for the MDD, and many of its requirements generally remain part of the new legislation, the MDR is, in fact, a new regulation with many new requirements and a new required structure, and must be treated as such.
In comparison to the MDD, the MDR puts greater emphasis on the safety of the medical devices throughout their lifecycle, which must be supported by robust clinical data. It also provides greater transparency by publishing more information on certified medical devices, conducted studies and clinical trials or post-market surveillance using the new European database on medical devices (Eudamed).
All newly introduced MDR requirements must be implemented by manufacturers before lodging a request for medical device conformity assessment under the MDR to a notified body. The notified body will then assess the established quality management system, review the technical documentation and attend the certification audit.
New Requirements of MDR for Medical Device Manufacturers
As mentioned above, many requirements from the MDD are also carried over to the MDR. Nevertheless, we encounter many new requirements. Among the most important of these we can include, for example, the following:
- Extension of the scope of the Regulation (Article 1 of the MDR), which now covers a wider range of products than was the case with the MDD. A specific example of newly covered medical devices is the group of products without an intended medical purpose (Annex XVI of the MDR) or devices designed to prevent or predict a disease or health condition.
- Tightening of certain classification rules (Annex VIII of the MDR). A medical device must be assigned to one of the risk classes according to the level of risk, duration and degree of invasiveness. Some medical devices are now assigned to a higher risk class and thus require a more demanding conformity assessment process. You can determine the risk class of your devices by using our Classification Rules for Medical Devices guidance HERE.
- The technical file has a new more detailed structure and content (Annex II and III of the MDR).
- The manufacturer must demonstrate compliance with the General Safety and Performance Requirements (Annex I of the MDR).
- The manufacturer must have a person responsible for regulatory compliance (Article 15 of the MDR). Manufacturers are required to designate this person within their organization, and the employee so designated, who must meet the specified qualification criteria, is ultimately responsible for compliance with the requirements of the MDR. The requirements in this respect are more lenient for micro and small enterprises, which can outsource this person.
- Mandatory registration of manufacturers and their devices in the European Database on Medical Devices Eudamed (once fully operational).
- Implementation of the Unique Device Identification system UDI, which will allow manufacturers and authorities to trace a specific medical device in the supply chain. The manufacturer shall assign to each of its medical devices a UDI (Article 27 MDR, Annex VI MDR).
- Broader involvement of notified bodies in the class I medical devices conformity assessment, specifically for devices placed on the market in sterile condition, devices with a measuring function or reusable surgical instruments. In these cases, the notified body always assesses the context of the device as it relates to these named aspects (Article 52, point 7 of the MDR).
- Tightening of requirements in the areas of clinical evaluation, post-market clinical follow-up (PMCF) and clinical trials (Article 61 MDR, Annex XIV MDR).
- Requiring more comprehensive clinical evidence, in particular for Class III medical devices and implantable medical devices, and the related tightening of the conditions for demonstrating equivalence (Article 61 of the MDR). If the manufacturers do not have sufficient clinical evidence to demonstrate the safety and performance of the medical device, they must usually conduct a full-scale clinical trial (Annex XV of the MDR).
- Implementation of a tighter and more comprehensive monitoring of the medical device after it is placed on the market (PMS) with the aim of minimizing the risks associated with dangerous devices (Article 83 MDR). Obligation to collect and maintain post-market clinical data as part of an ongoing assessment of potential risks. In many cases, the periodic safety update report (PSUR) is also required (Article 86 MDR).
- Obligation to regularly draw up a Summary of Safety and Clinical Performance (SSCP) for implantable devices and for class III devices (Article 32 MDR).
- The notified body conformity assessment procedure is more comprehensive and detailed than before (Annex VII, point 4.5 of the MDR, Annexes IX - XI of the MDR).
How to Implement Requirements of the MDR into Your QMS Step by Step
Are you planning to implement MDR requirements into your quality management system? Below are the most important steps to help you to prepare for what lies ahead.
1. Baseline evaluation
- Inform the management about the importance of MDR and the related impacts on your company
- Consider the current state of the company: employees and their qualifications, financial resources, state of internal regulations, current quality of documentation, etc.
2. Initial analysis
- Assess the impact of MDR implementation on your company, products, internal procedures and budget
- Check the new definition of a medical device to see if your product falls under it
- Review the new classification rules according to Annex VIII of the MDR and classify your medical device
- Study the conformity assessment procedures and identify the one to use for your medical device
- Identify necessary changes in existing technical documentation
- Check the adequacy of risk management and identify any deficiencies
- Check the correct labelling of products and implement the UDI
- Identify the necessary modifications to your quality management system to meet the new MDR requirements
- Contact the selected notified body, send them a non-binding inquiry and find out their capacity to assess your device
3. Clinical area
- Check the adequacy of the clinical evidence and, if necessary, consider addition to the required extent (clinical trial, etc.)
- Ensure compliance with device traceability obligations and prepare for new vigilance requirements
- Prepare a procedure for post-market clinical follow-up
4. Legal aspects
- Identify the person responsible for regulatory compliance and ensure that this person is properly qualified and trained
- Register your company as a manufacturer and obtain the Single Registration Number (SRN)
- Ensure that your product liability insurance is sufficient
5. Product portfolio
- Analyse your product portfolio. Keep in mind the costs of possible changes in medical device classification and new conformity assessment processes, as well as the costs of the elimination of insufficiency of technical documentation, etc.
- Verify the readiness of your suppliers and distributors and their ability to fulfil the specified requirements
6. Implementation plan
- Create a detailed implementation plan defining the sub-steps you will need to take to implement all MDR requirements
- Pay particular attention to the transition period, the associated requirements for its use as well as the availability of your notified body
7. Implementation of requirements
- Execute the individual sub-steps according to the implementation plan
- Ensure that a project team is available to carry out all parts of the implementation and that responsibilities for sub-steps are clearly defined
- Establish regular review days to assess progress against the implementation plan and identify potential risks
8. Certification
- Apply for medical device conformity assessment and sign a contract with a notified body
- Start the conformity assessment process with the notified body in order to obtain the certificate
- Obtain the certificate, draw up a declaration of conformity and place your medical device on the market