Manufacturers' guide to IVDR Update related to EUDAMED
MDCG 2022-12 Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
Article 33 of Regulation (EU) 2017/745 on medical devices1 (MDR) and Article 30 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)2 requires the Commission to set up a European database on medical devices (‘Eudamed’).
The guidance 2022-12 recalls various factors related to the requirement of all 6 modules to be functional and quotes Article 113(3)(f) from the EU IVD Regulation [IVDR] which addresses the possibility that Eudamed is not fully functional on the date of application of the IVDR (26 May 2022).
Accordingly, the obligations and requirements in the IVDR that relate to Eudamed shall apply from the date corresponding to six months after the date of publication of the notice referred to in Article 34(3) MDR – notice of full functionality of Eudamed. Until Eudamed is fully functional, the IVDR stipulates that the corresponding provisions of Directive 98/79/EC4 shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 113(3)(f) IVDR regarding the exchange of information. In addition, Article 113(3)(a) IVDR clarifies that Article 26(3) IVDR on the registration of devices, and Article 51(5) IVDR on the registration of certificates, start to apply 24 months after the date of publication of the notice referred to in Article 34(3) MDR.
This document provides guidance to Member States and other relevant parties on the application of certain IVDR provisions during the absence of Eudamed. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.
The proposed practices and solutions aim to enable Member States and other relevant parties to meet their obligations under the IVDR effectively while minimising any potential additional burden on the parties concerned. This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directive 98/79/EC.
The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR. Whenever this guidance makes reference to CircaBC as alternative solution, the Commission and other relevant parties should endeavour to make use of already existing CircaBC directories to the extent that this is possible and appropriate.
Parties should also take note of the MDCG Position Paper on the use of the Eudamed actor registration module and of the Single Registration Number (SRN) in the Member States.
From all the updates mentioned in the guidance document, our experts have tried compiling text relevant to Manufacturers of In-Vitro Diagnostic Devices [IVDs]. For complete understanding, we strongly recommend the use of the guidance document which is accessible from here.
The Article 26 of IVDR talks about Registration of devices –
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR) states that
- Before placing a device, on the market, the manufacturer shall, in accordance with the rules of the issuing entity referred to in Article 24(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and shall provide it to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
- For devices that are the subject of a conformity assessment as referred to in Article 48(3) and (4), in the second subparagraph of Article 48(7), Article 48(8) and the second subparagraph of Article 48(9), the assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done before the manufacturer applies to a notified body for that assessment. For the devices referred to in the first subparagraph, the notified body shall include a reference to the Basic UDI-DI on the certificate issued in accordance with point (a) of Section 4 of Annex XII and confirm in Eudamed that the information referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the relevant certificate and before placing the device on the market, the manufacturer shall provide the Basic UDI-DI to the UDI database together with the other core data elements referred to in Part B of Annex VI related to that device.
- Before placing a device on the market, the manufacturer shall enter or, if already provided, verify in Eudamed the information referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2 thereof, and thereafter shall keep the information updated.
According to the guidance document - Alternative solutions to submit and/or exchange information (as required under the IVDR) states
Paragraphs 1-3: Note: The functionality is available in Eudamed. The system may be used (on voluntary basis) for registration of devices even before the notice of full functionality of Eudamed has been published.
Nevertheless, manufacturers should refer to the national provisions in Member States establishing product registration schemes.
Manufacturers should note that the obligation of UDI assignment (Basic UDI and UDI-DI) to a device applies from 26 May 2022 (Art. 24(3) IVDR). Labelling requirements apply gradually, starting from 26 May 2023, according to the timelines set out in Art. 113(3)(e) IVDR.
The guidance document clearly specifies - The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.
The Article 29 of IVDR talks about Summary of safety and performance
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR) states that
- For class C and D devices, other than devices for performance studies, the manufacturer shall draw up a summary of safety and performance. The summary of safety and performance shall be written in a way that is clear to the intended user and, if relevant, to the patient and shall be made available to the public via Eudamed. The draft of the summary of safety and performance shall be part of the documentation to be submitted to the notified body involved in the conformity assessment pursuant to Article 48 and shall be validated by that body. After its validation, the notified body shall upload the summary to Eudamed. The manufacturer shall mention on the label or instructions for use where the summary is available.
According to the guidance document - Alternative solutions to submit and/or exchange information (as required under the IVDR) states
The SSP shall be made available to the public upon request without undue delay, or the manufacturer shall specify where it is made available to the public.
The Article 81 of IVDR talks about Periodic safety update report (PSUR)
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR) states that
[…]
- Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system 3. For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.
According to the guidance document - Alternative solutions to submit and/or exchange information (as required under the IVDR) states
For class D devices, manufacturers should deliver the PSURs to the relevant notified bodies by appropriate means, such as secure email.
And then the, Notified bodies should provide the PSURs and corresponding evaluations to the manufacturers and make them available upon request to the competent authority.
Not to forget - The guidance document clearly specifies - The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.
This news update by Med-Di-Dia Ltd. is only to help Manufacturers to have a quick glance to the text marked as – Manufacturer - under the Responsible actor(s) section of the guidance. For complete understanding, we strongly recommend the use of the guidance document which is accessible from here.
The Article 82 of IVDR talks about Reporting of serious incidents and field safety corrective actions
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR) states that
- Manufacturers of devices made available on the Union market, other than devices for performance studies, shall report, to the relevant competent authorities, in accordance with Articles 87(5) and (7), the following:
- any serious incident involving devices made available on the Union market, except expected erroneous results which are clearly documented and quantified in the product information and in the technical documentation and are subject to trend reporting pursuant to Article 83;
- any field safety corrective action in respect of devices made available on the Union market, including any field safety corrective action undertaken in a third country in relation to a device which is also legally made available on the Union market, if the reason for the field safety corrective action is not limited to the device made available in the third country.
The reports referred to in the first subparagraph shall be submitted through the electronic system referred to in Article 87. […]
- 9. For similar serious incidents that occur with the same device or device type and for which the root cause has been identified or a field safety corrective action implemented or where the incidents are common and well documented, the manufacturer may provide periodic summary reports instead of individual serious incident reports, on condition that the coordinating competent authority referred to in Article 84(9), in consultation with the competent authorities referred to in point (a) and (b) of Article 87(8), has agreed with the manufacturer on the format, content and frequency of the periodic summary reporting. Where a single competent authority is referred to in points (a) and (b) of Article 87(8), the manufacturer may provide periodic summary reports following agreement with that competent authority.
(In accordance with Article 87 (1) and (8), the periodic summary reports are to be submitted via the electronic system referred to in Article 87). […]
According to the guidance document - Alternative solutions to submit and/or exchange information (as required under the IVDR) states
Manufacturers should report serious incidents and field safety corrective actions to the respective/relevant national vigilance systems.
The new MIR form has already been adapted to IVDR requirements and should be used accordingly. The current FSCA form should be used (any additional information required under the IVDR may be added to the general comments section of the form).
The current PSR Form should be used (the additional information required under the IVDR may be added to the general comments section of the form). It should be transmitted by the manufacturers via the national vigilance systems.
The Article 83 talks about Trend reporting
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR)
Manufacturers shall report, by means of the electronic system referred to in Article 87, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable side- effects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to unacceptable risks to the health or safety of patients, users or other persons or of any significant increase in expected erroneous results established in comparison to the stated performance of the device as referred to in points (a) and (b) of Section 9.1 of Annex I and specified in the technical documentation and product information. […]
Alternative solutions to submit and/or exchange information (as required under the IVDR)
Paragraph 1: Manufacturers must submit trend reports to the respective / relevant national vigilance systems. The current Trend report form should be used until its updating for IVDR compliance.
Along with the Manufacturers, the Members states (national vigilance system) shall be responsible for this provision.
The Article 84 talks about Analysis of serious incidents and field safety corrective actions
Provisions related to the use of Eudamed (as referred to in Art. 113 (3) (f) IVDR)
[…]
- The manufacturer shall provide a final report to the competent authority setting out its findings from the investigation by means of the electronic system referred to in Article 87. The report shall set out conclusions and where relevant indicate corrective actions to be taken.
7. After carrying out the evaluation in accordance with paragraph 3 of this Article, the evaluating competent authority shall, through the electronic system referred to in Article 87, inform, without delay, the other competent authorities of the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident, including information on the underlying events and the outcome of its assessment.
8. […] The manufacturer shall enter the field safety notice in the electronic system referred to in Article 87 through which that notice shall be accessible to the public. […]
9. […] The coordinating competent authority shall, through the electronic system referred to in Article 87, inform the manufacturer, the other competent authorities and the Commission that it has assumed the role of coordinating competent authority.
According to the guidance document - Alternative solutions to submit and/or exchange information (as required under the IVDR) states
Paragraph 5: Manufacturers should submit the final report to the respective / relevant national vigilance system.
Paragraph 7: Communication with other competent authorities should take place through a dedicated secure directory in CircaBC (organised by the Commission) for IVDR devices. For Legacy and older devices, the existing Eudamed2 system for NCAR should continue to apply.
Paragraph 8 (third sub-paragraph): Manufacturers should submit the field safety notices to the respective/relevant national vigilance systems. The respective/relevant competent authorities should make these field safety notices publicly available/accessible to the public in accordance with their national legislation.
Paragraph 9: The coordinating competent authority shall inform by email or other suitable communication channels, the other competent authorities, the manufacturer and the Commission that it has assumed the role of coordinating competent authority.
Along with the Manufacturers, Member States (national vigilance system) Commission, Member States (CircaBC), Member States (Eudamed2) shall be responsible for this provision.
Not to forget - The guidance document clearly specifies - The proposed practices and solutions set out in this document do not affect the general obligations of the parties to comply with the applicable requirements under the IVDR.
This update by Med-Di-Dia Ltd. is only to help Manufacturers to have a quick glance to the text marked as – Manufacturer - under the Responsible actor(s) section of the guidance. For complete understanding, we strongly recommend the use of the guidance document which is accessible from here.
The update can be overwhelming to read and challenging to follow!
Manufacturers should use the services provided by our experts to navigate the regulatory requirements.
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