Kiri

Dear,

Thank you for initiating this inquiry.

Please find our replies below in green.

Will you please share the outcome of the survey? Do you plan to discuss the results on EU level (MDCG?, EDQM?) in order to streamline the procedure ?

Kind regards,

Rafael

Dear colleagues,

I am the Chief Specialist of the Medical Devices Department of the Estonian Health Board.

I have now worked for a year in the Health Board and one of my responsibilities is SER.

I have some thoughts/questions regarding the evaluation of SERs.

Based on the feedback we have received, we have noticed that only a maximum of 6 countries are responding and we are only seeing comments in a few cases. We understand that countries send their comments directly to the coordinating competent authority, but it would also be good to see feedback from other countries on SERs.

Also we see from our data that the number of SERs is increasing.

2019 – 14 SER

2020 – 23 SER

2021 – 12 SER

2020 – 20 SER

2023 – 40 SER

2024 – 26 (from the beginning of the year until 01.08.2024).

We would therefore like to ask you for some information.

Please answer the questions below, we would very much appreciate your input.

1. Do you respond to SERs (make comments, remarks, suggestions, etc)? YES, if an EDQM certificate is not available.

2. If not, what is the reason?

3. Do you think it is important to evaluate SERs? YES

4. If you deal with SERs, how many people review/verify SERs? 1

5. Do you send the evaluations of SER directly to the coordinating competent authority or to all EU competent authorities? Directly to the coordinating competent authority

6. Do you see a growing trend in the market for the use/manufacture of medical devices containing animal tissues? YES

To summarise, I would like to add some information on competent authorities in the assessment of SER reports.

Considering (EU) 2017/745 Annex IX Chapter II section 5. 5.   Specific additional procedures

5.3.1.   Tissues or cells of human origin or their derivatives

(d) Before any change is made with respect to non-viable tissues or cells of human origin or their derivatives incorporated in a device, in particular relating to their donation, testing or procurement, the manufacturer shall inform the notified body of the intended changes. The notified body shall consult the authority that was involved in the initial consultation, in order to confirm that the quality and safety of the tissues or cells of human origin or their derivatives incorporated in the device are maintained. The human tissues and cells competent authority concerned shall take into account the data relating to the usefulness of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues or cells of human origin or their derivatives in the device. It shall provide its opinion within 60 days of receipt of all the necessary documentation regarding the intended changes. The notified body shall not deliver a supplement to the EU technical documentation assessment certificate if the scientific opinion is unfavourable and shall convey its final decision to the human tissues and cells competent authority concerned.

5.3.2.   Tissues or cells of animal origin or their derivatives

In the case of devices manufactured utilising animal tissue which is rendered non-viable or utilising non-viable products derived from animal tissue, as referred to in Regulation (EU) No 722/2012, the notified body shall apply the relevant requirements laid down in that Regulation.

According Commission Regulation (EU) No 722/2012  (8) The Member States should verify that the notified bodies designated to assess the conformity of medical devices manufactured utilising animal tissues have the necessary expertise and up-to-date knowledge to perform this task.

According (EU) No 722/2012 Article 4

1.   Member States shall verify that bodies notified under Article 11 of Directive 90/385/EEC or Article 16 of Directive 93/42/EEC have up-to-date knowledge of the medical devices referred to in Article 1(1), in order to assess the conformity of those devices with the provisions of Directive 90/385/EEC or Directive 93/42/EEC, respectively, and with the particular requirements laid down in Annex I to this Regulation. Member States shall regularly verify that those bodies maintain the required up-to-date knowledge and expertise.

4.   Before issuing an EC design-examination certificate or an EC type-examination certificate, the notified bodies shall, through their competent authority, hereinafter ‘coordinating competent authority’, inform the competent authorities of the other Member States and the Commission of their assessment carried out pursuant to paragraph 2 by means of a summary evaluation report in accordance with Annex II to this Regulation.

Yours sincerely,

Maarika Ojala

Chief Specialist

Department of Medical Devices

+372 5400 4028

[email protected]

Republic of Estonia

Health Board

+372 794 3500

[email protected]

www.terviseamet.ee

Paldiski mnt 81, 10614 Tallinn

Estonia

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