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Location:Home > News > Industry newsIndustry news

MDR eudamed practices and alternative technical solutions before full operation

浏览次数:1006次     发表时间:2021-03-31

Article 33 of the Medical Device MDR Regulation (EU) 2017/745 requires the Commission to establish a European Medical Device Database (EUDAMED). EUDAMED has a total of six modules. The functions involved include Actor Registration, unique device identification and device registration, notified bodies and certificates, and clinical Test and performance research module (clinical investigations and performance studies) and vigilance and market surveillance module (vigilance and market surveillance)

On October 30, 2019, the European Commission issued a notice that the full functionality of EUDAMED requires the availability and complete operation of all six modules. The notice expects that EUDAMED will be launched in May 2022, which is related to the applicable date of the In Vitro Diagnostic Medical Device (IVDR) Regulation (EU) 2017/746. In this regard, it should be noted that the official launch of EUDAMED in May 2022 does not affect the implementation date of the MDR on May 26, 2021.

Article 123(3)(d) of the MDR Regulation explains the possibility that EUDAMED will not fully function on the date of implementation of the MDR (May 26, 2021). Therefore, the obligations and requirements related to EUDAMED in the MDR shall take effect 6 months after the announcement of EUDAMED's complete functions.

Until EUDAMED is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC4 and 93/42/EEC5 shall continue to apply to fulfill the obligations stipulated in Article 123(3)(d) on the exchange of information.


On February 26, 2021, the European Union Medical Equipment Coordination Group MDCG issued the coordination guidance document "MDCG 2021-1 EUDAMED Practices and Alternative Technology Solutions Before Full Operation", which will be implemented by EU member states and other relevant parties during the absence of EUDAMED Guidance is provided in relation to EUDAMED's MDR clauses. The specific alternatives are as follows.

If the following clarifies the functions that should be implemented on EUDAMED, other alternatives are available before these functions are released:

1. Device registration

Once the relevant functions in Eudamed are available, they can be used for device registration before Eudamed's full functions are released. Prior to this, manufacturers should refer to the domestic regulations of member states when establishing a device registration plan. In addition, manufacturers also need to pay attention to the allocation of UDI (Basic UDI and UDI-DI) to the device from May 26, 2021, and the UDI requirement on the device label will gradually take effect over time;

2. Registration of manufacturers, authorized representatives and importers (Article 31 of the MDR)

Once the relevant functions in Eudamed are available, they can be used for the registration of manufacturers, authorized representatives and importers before the release of Eudamed's complete functions. However, before that, manufacturers, authorized representatives and importers should refer to the domestic regulations of the member states. Please refer to MDCG's position paper on the use of EUDAMED registration modules and single registration numbers (SRN) in member states.

3. Safety and clinical performance summary SSCP (MDR Article 32)

SSCP should be provided to the public in a timely manner, or the manufacturer should explain how to provide it to the public. Once the relevant functions in Eudamed are available, they can be used to upload SSCP before Eudamed's full functions are released.

4. European Medical Device Database (MDR Article 33)

From the date when the committee provides each EUDAMED module, relevant information can be submitted on a voluntary basis.

5. Nomination of experts for joint assessment by notifying agencies (Article 40 of the MDR)

The European Commission provides this list to member states through a dedicated security catalog in the Administrative, Business and Citizen Communication and Information Resource Center (CircaBC).

6. Appointment and announcement process (MDR Article 42)

The final assessment report of the competent authority, the final opinion of the joint assessment team, and the recommendations, opinions and objections of the MDCG can be inquired through CircaBC's dedicated security catalog. The issuance of the notice continues through NANDO.

7. Identification number and list of notified bodies (Article 43 of the MDR)

This information will continue to be provided through NANDO.

8. Supervision and re-evaluation of the notified body (Article 44 of the MDR)

Member states should upload the report to CircaBC. The European Commission should provide the public with a summary of the report.

9. Designation and announcement changes (MDR Article 46)

Requests for suspension or revocation of certificates should be managed at the national level. Use appropriate communication channels (for example, CircaBC) to notify the medical device competent authority of the Member State where the manufacturer is registered.

10. Notifying agencies participate in the conformity assessment process (MDR Article 53)

The notified body should upload the required information to CircaBC's dedicated security catalog and use a pre-defined template. The required information can also be provided through the national system, provided that the notification requirements of all other agencies are complied with.

11. The consultation process for clinical evaluation of specific class III devices and class IIb devices (MDR Article 54)

The notified body should use a predefined template to upload the required information to CircaBC's dedicated security catalog to notify relevant parties. The European Commission will provide and manage a technical platform related to the operation of the expert group.

12. The review mechanism for the conformity assessment of specific Class III devices and Class IIb devices (MDR Article 55)

The notified body shall upload the necessary certificates and other mandatory information cited in this clause to the CircaBC catalog.

13. Certificate of Conformity (Article 56 of the MDR)

The notified body shall provide the certificate upon request, or upload it to the national system when needed. Note: Once this function is available in Eudamed, even before Eudamed's full function is released, you can also use this function to upload certificates.

14. Application for clinical research (MDR Article 70)

The application for clinical research shall be conducted through the procedures of the Member State where the clinical research is conducted. Non-substantive changes to clinical research protocols should be reported through the procedures of the Member States before implementation, unless the Member States provide otherwise.

15. Electronic clinical research system (Article 73 of the MDR)

After Eudamed2 submits the required information to the system, it will generate a unique unique identification number ("CIV-ID") within the EU for clinical research (continuing the current MDD practice). The submission of clinical research applications or notifications, and in this case all other data submissions or data processing shall be carried out through the corresponding national procedures of the Member State where the clinical research is carried out. The member states as well as the member states and the European Commission should adopt temporary communication methods, such as regular teleconferences or collaborative platforms (such as CircaBC or other online platforms), to exchange information about clinical research. The information provided by the sponsor in accordance with the provisions of Article 77, including the clinical research reports and their abstracts as prescribed in paragraph 5 of this Article, shall be conducted through the corresponding national procedures of the Member State where the clinical research is carried out. Use a special public directory to publish CI reports and corresponding summary reports. The release process should be coordinated by the MDCG coordination group to avoid duplication. Serious adverse events and device defects and related updates should be carried out through the corresponding national procedures of the member country where the clinical research is carried out, and in accordance with MDCG's guidelines on clinical research safety reports.

16. Clinical research of CE marked devices (Article 74 of the MDR)

Through the relevant national procedures of the member country where the clinical research is carried out.

17. Substantial revision of clinical research (Article 75 of the MDR)

Through the relevant national procedures of the member country where the clinical research is carried out.

18. Corrective actions by member states and information exchange between member states (MDR Article 76)

Use the pre-defined template to upload the required information to the security dedicated directory within CircaBC.

19. Information provided by the sponsor at the end of the clinical study, suspension or early termination (MDR Article 77)

It is carried out through the relevant national procedures of the member states where clinical research is carried out, and the CI report and summary report are shared and released through the use of a special public catalog.

20. Coordinated evaluation process for clinical research (Article 78 of the MDR)

This procedure is mandatory from May 27, 2027. Prior to this, the application of the program was voluntary. MDCG will provide further guidance documents on voluntary procedures when necessary.

21. Record and report adverse events during clinical research (MDR Article 80)

It is carried out through the relevant national procedures of the member states where the clinical research is carried out, and is carried out in accordance with the MDCG guidelines on medical device clinical research safety reports under Regulation (EU) 2017/745.

22. Regular security update report PSUR (MDR Article 86)

For Class III devices and Class IIa and IIb implantable devices, the manufacturer shall deliver the PSUR to the relevant notified body through an appropriate method. The notified body shall provide the PSUR and the corresponding assessment to the manufacturer, and provide it to the competent authority upon request.

23. Report serious incidents and corrective measures for on-site safety (MDR Article 87)

Manufacturers should report serious accidents and on-site safety corrective actions to their/relevant national alert systems. When reporting, the new MIR form should be used. When using the FSCA form and the periodic summary report form, other information required by the MDR can be added to the general comment section of the form and submitted through the national alert system.

24. Trend report (Article 88 of the MDR)

Manufacturers must submit trend reports to their/relevant national alert systems.

25. Severe incident analysis and on-site safety corrective measures (MDR Article 89)

The manufacturer shall submit the final report to the relevant national alert system. Communications with other competent authorities should be conducted through a dedicated security catalog in CircaBC. The manufacturer shall submit the on-site safety notice to the corresponding/relevant national alert system. The relevant competent authority shall make these on-site safety notices public/open to the public in accordance with their national regulations.

26. Vigilance data analysis (MDR Article 90)

Data monitoring can be carried out from the date when the EUDAMED alert module is provided.

27. Market supervision activities (Article 93 of the MDR)

The competent authority should notify other relevant authorities by uploading the summary document to the dedicated security catalog in CircaBC. Before this date, the competent authorities of the Member States can provide a summary of the results to the public on their website.

28. Procedures for handling devices that pose unacceptable risks to health and safety (MDR Article 95)

The competent authority shall notify the other interested parties via e-mail or using other appropriate communication channels, using a predetermined template (once it becomes available). Information shared electronically should be encrypted when possible and necessary.

29. Other non-compliance items (Article 97 of the MDR)

Member States should notify the Committee and other Member States via email using a predetermined template (as soon as it becomes available). Information shared electronically should be encrypted as much as possible.

30. Preventive health protection measures (MDR Article 98)

Member States should notify the Committee and other Member States via email using a predetermined template (as soon as it becomes available). Information shared electronically should be encrypted as much as possible.

31. Good administrative regulations and practices (MDR Article 99)

The competent authority shall notify the relevant designated agencies and responsible departments by e-mail. Information shared electronically should be encrypted as much as possible.

32. Transitional provisions (Article 120 of the MDR)

Considering the availability of each EUDAMED module, the alternative technical solutions proposed in this document should also be applied to legacy equipment as appropriate. The registration of certificates issued under the directive should be carried out in Eudamed2.

Note: Part of the content comes from the Internet


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