14 Questions To Self-Check Medical Device Regulation (MDR) Compliance

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EU Medical Device Regulation (MDR) 2017/745 expands the scope of regulation and imposes strict requirements on medical device companies in terms of quality management systems, clinical evidence, market supervision, etc. Proregulations summarizes 14 questions related to key points in the MDR pathway to help companies systematically assess their compliance.

1. Does your product meet the definition of a medical device or accessory under MDR?

First, it is necessary to confirm whether your product complies with the definition of medical devices or accessories as stipulated in the MDR. The MDR is more stringent and detailed in the product definition than the previous MDD. Some products that were not considered medical devices before, such as certain beauty or hair transplant tools, have now been included in the regulatory scope.

In addition, special attention should be paid to the products listed in Appendix XVI of the MDR. Even if these products have no clear medical purpose, they are still subject to the regulations of the MDR. An incorrect judgment may result in a wrong compliance path and significant compliance risks.

2. If your device is in the Class I self-declaration category, does your quality management system (QMS) cover all the elements of section 10 of the MDR?

Although Class I self-declaration devices are not subject to notified body audits, manufacturers must establish and maintain a complete QMS to comply with the requirements of MDR section 10, which should include risk management, clinical evaluation, Post-Market Surveillance (PMS), and Declaration of Conformity (DoC) processes. Basic ISO 13485 certification alone is usually not sufficient to fully cover the MDR requirements and must be implemented on a clause-by-clause basis for the MDR.

3. If your device is up-categorized from a Class I self-declaration category and you are taking advantage of the 4-year transition period allowed in Amendment 2, do you still have plans to meet the remaining MDR compliance requirements?

For devices that have been up-categorized and are taking advantage of the transition period exemption based on Amendment 2, there is still a plan to move forward with MDR full compliance preparation. This includes contracting with a new Notified Body, completing technical documentation rebuilds, developing an MDR-compliant PMS plan, and implementing Person Responsible for Regulatory Compliance (PRRC) appointments to ensure a seamless switchover before the end of the transition period to avoid compliance breakpoints.

4. Are you still using a CE certificate issued by the MDD? Are there any plans to make significant changes to the device before the certificate expires?

Currently the MDD CE certificate is still valid during the transition period, but any major changes may trigger re-compliance with the MDR requirements and loss of the protection of the MDD certificate. Therefore, it is important that you conduct a risk assessment of planned product changes and, if necessary, initiate the MDR compliance transition in advance to avoid a certificate interruption that would render the product unmarketable.

5. Have you conducted a gap analysis to identify potential gaps between MDD and MDR?

MDR imposes higher compliance requirements in many aspects compared to MDD, such as more comprehensive clinical data support, a more stringent PMS system, and clearer delineation of responsibilities for economic operators. A systematic gap analysis can help companies identify gaps in their existing compliance systems and develop a targeted transition plan to avoid major non-conformities when formally transitioning to MDR.

6. Have you audited the device for compliance with the relevant General Safety and Performance Requirements (GSPRs) in MDR Appendix I?

MDR Appendix I lists the GSPRs that must be met by the device, covering risk control, clinical performance validation, biocompatibility, electromagnetic compatibility, and labeling information. Each applicable requirement requires adequate documentation of compliance (e.g., test reports, validation records, scientific evidence, etc.), and omission or inadequacy of any of these may result in nonconformity during the certification audit.

7. Does your Clinical Evaluation Report (CER) meet at least the requirements of MEDDEV 2.7.1 Revision 4?

MDR requires that clinical data be adequate, factual, and systematic. Even if existing literature or equivalent device data are used, the evaluation methodology of MEDDEV 2.7.1 rev.4 must be met. If direct clinical data are missing, a rational explanation needs to be provided and a Post-Market Clinical Follow-up (PMCF) program needs to be developed. Ignoring this part of the requirement will seriously affect the technical documentation review pass rate.

8. Have you updated the technical documentation to meet the requirements of MDR Appendix II?

MDR Appendix II specifies that the technical documentation includes device description and specifications, information provided by the manufacturer, design and manufacturing information, basic safety performance requirements, benefit-risk analysis and risk management, and product verification and validation sections. You should update the technical documentation in a timely manner to ensure compliance with all the requirements of the six core elements of MDR Appendix II.

9. Have you revised the agreement with Economic Operators (EOs) to comply with the requirements of section 11-14 of the MDR?

Economic Operators (authorized representatives, importers, and distributors) have greater responsibilities under the MDR and must undertake obligations such as product conformity, complaint handling, and cooperation in recalls. Therefore, contracts signed with various EO types need to clearly define the specific responsibilities of each party in terms of regulatory compliance, information transmission, traceability, and recall procedures, and adjust liability insurance arrangements based on the risk level of the medical device.

10. Have you developed a PMS program that complies with MDR Appendix III?

MDR requires manufacturers to establish a systematic and proactive PMS mechanism that not only passively collects adverse events, but also proactively collects information such as clinical utilization data, user feedback, and literature reports, etc. The PMS plan should include data collection methodology, trend analysis, and corrective action procedures, etc., and be incorporated into an annually updated PMS report or PSUR.

11. Have you assigned a PRRC that meets the qualification criteria set forth in section 15 of the MDR?

The MDR requires that a statutorily-qualified PRRC be assigned to each manufacturer to be directly responsible for product compliance assurance. The PRRC needs to have a relevant academic background (e.g., legal, medical, engineering) and years of experience in regulatory affairs, and is an important player in ensuring that the organization remains in compliance and responds to authorities' requests in a timely manner.

12. Have you confirmed that an existing Notified Body will be designated under the MDR and will cover your device's scope?

Notified Bodies (NBs) need to be re-qualified for designation under the MDR and must cover the corresponding scopes. Companies must confirm that the NB they are currently working with meets the requirements, and if not, they should look for a new NB as soon as possible to avoid delays in audits and certifications.

13. Do you have a written plan that meets the requirements of MDR sections 120 and 123?

Sections 120 and 123 of the MDR specify the transition period and effective date arrangements. Enterprises need to develop a detailed written plan that identifies tasks, timelines, responsible parties and key milestones to ensure that they are fully migrated to the MDR system within the statutory timeframe and avoid compliance risks due to improper time planning.

14. Has your QA/RA/audit team received MDR training? Have you conducted internal audits to validate compliance?

MDR introduces a large number of new concepts and requirements, and QA, RA and internal audit teams must undergo special training to ensure that they understand and can correctly apply the relevant provisions. At the same time, internal audits should be organized regularly to check the compliance of each department and process against the MDR provisions, and identify problems and take corrective actions timely.

Our Services

Proregulations specializes in medical device regulatory affairs and product compliance management, and is committed to helping companies make the transition from MDD to MDR. Whether it is a new device entering the EU market or a mature product in transition, we can customize the most appropriate compliance pathway for you to reduce compliance risk and improve your competitiveness in the marketplace.

Our MDR-related services include:

MDR compliance path assessment and strategy development
MDR regulations training
Product classification and applicability analysis
MDR technical documentation preparation and review
CER writing and pre-audit
PMS and PMCF program design
MDR GAP analysis and rectify recommendations
PRRC outsourcing services

Proregulations not only conducts in-depth research on regulations, but also excels at translating regulations into actionable solutions, helping your products enter the EU market in a compliant, safe and efficient manner. If you are interested in our services, please contact us.

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