(fra kommisjonsforordningen)

(1) Pursuant to Article 7(4) of Regulation (EU) 2021/2282, the Commission, after seeking a recommendation from the Member State Coordination Group on Health Technology Assessment established under Article 3 of that Regulation (‘the Coordination Group’), is to adopt a decision, by means of an implementing act and at least every two years selecting for joint clinical assessment medical devices and in vitro diagnostic medical devices (‘medical devices’). The Commission is to select those devices from the medical devices for which the relevant expert panels designated in accordance with Article 106(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (‘the expert panels’) provided a scientific opinion or their views. 

(2) Pursuant to Commission Implementing Regulation (EU) 2024/2699, the European Medicines Agency is to provide the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) with information on all medical devices for which the expert panels provided a scientific opinion or their views no later than 15 days after the end of each quarter, pertaining to that quarter. 

(3) Due to confidentiality related to the medical devices’ certification process, the adoption of the Commission decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selecting medical devices for joint clinical assessment can only be launched after the certification process of the medical device is completed.

(4) At the same time, in order to prevent the duplication of assessments on the same medical device by the Coordination Group and by Member States’ health technology assessment authorities and bodies, it is crucial that joint clinical assessment of those devices starts as soon as the device is certified under Regulation (EU) 2017/745 or Regulation (EU) 2017/746 of the European Parliament and of the Council, as applicable. Therefore, first, upon the adoption of the recommendation of the Coordination Group, the HTA secretariat should inform the health technology developers of medical devices recommended by the Coordination Group to be selected for joint clinical assessment of that recommendation, and the reasons thereof. This will also allow for adequate preparation for health technology developers for the upcoming joint clinical assessment. Second, the notified bodies designated in accordance with Regulation (EU) 2017/745 or Regulation (EU) 2017/746 (‘the notified bodies’) should be required to inform the HTA secretariat of the results of the certification process of the medical devices covered in the recommendation of the Coordination Group. Finally, upon the granting of the certificate of conformity by the notified body, the health technology developers should be invited to submit to the HTA secretariat the information necessary for the development of the assessment scope provided for in Article 8(6) of Regulation (EU) 2021/2282 (‘the assessment scope’). 

(5) In order to prevent the duplication of information submission and to reduce the administrative burden, the notified bodies should not be required to provide to the HTA secretariat the information that is already duly and fully available in the European database on medical devices referred to in Article 33 of Regulation (EU) 2017/745 and Article 30 of Regulation (EU) 2017/746. The health technology developers may provide to the HTA secretariat the requested information by referring to its registration in that database. 

(6) Where in specific warranted instances the Commission in its decision referred to in Article 7(4) of Regulation (EU) 2021/2282 and adopted in accordance with the examination procedure referred to in Article 33(2) thereof selects for joint clinical assessment medical devices which were not recommended to be selected for joint clinical assessment by the Coordination Group, the health technology developers of those devices should provide information necessary for the development of the assessment scope. 

(7) Due to the specificities of medical devices, some of the required evidence, such as the evidence to address some research questions of the assessment scope, may only become available after the medical device has been placed on the market. In such instances, where the joint clinical assessment of the medical device has been initiated soon after its certification under Regulation (EU) 2017/745 or Regulation (EU) 2017/746, it should be possible for the Coordination Group to assess the additional evidence by way of initiating the relevant updates of the joint clinical assessment. Joint scientific consultations can also facilitate the process of preparing relevant updates of joint clinical assessment of medical devices when the requests for joint scientific consultation meet the eligibility and selection criteria. 

(8) It is necessary to ensure legal certainty for health technology developers of medical devices which the Coordination Group or its relevant subgroup considered in the preparation of its recommendation, but which it did not recommend to be selected for joint clinical assessment. Therefore, the HTA secretariat should also inform the health technology developers of such medical devices that the Coordination Group did not recommend selecting those devices for joint clinical assessment. Those medical devices may however still be selected for joint clinical assessment at a later point in time, for example when new information relating to their compliance with the selection criteria set out in Article 7(4) of Regulation (EU) 2021/2282 becomes available after their placing on the market. 

(9) In order to ensure the cooperation, in particular by exchange of information, of the Coordination Group with the expert panels on the preparation and update of joint clinical assessments of medical devices, in particular as regards the application of the selection criteria listed in Article 7(4) of Regulation (EU) 2021/2282, the HTA secretariat should inform the expert panels of the recommendation of the Coordination Group. Pursuant to Article 30 of Regulation (EU) 2022/123 of the European Parliament and of the Council, the European Medicines Agency is acting as secretariat for those expert panels. Therefore, the exchange of information between the Coordination Group and the expert panels should be conducted via the HTA secretariat and the European Medicines Agency. 

(10) In light of the tasks of the HTA secretariat set out in Regulation (EU) 2021/2282, the exchange of information with the health technology developers, notified bodies, patients, clinical experts and other relevant experts (‘individual experts’) and Member States on the preparation and update of joint clinical assessments should take place through the HTA secretariat. The HTA secretariat should ensure that all the information it receives is communicated to the Coordination Group, the subgroup of the Coordination Group on joint clinical assessments (‘the JCA Subgroup’) and assessor and co-assessor for joint clinical assessment appointed pursuant to Article 8(4) of Regulation (EU) 2021/2282 (‘the assessor and co-assessor’), as appropriate, upon receipt of that information.

(11) To ensure the right to good administration, the health technology developer should be informed of the start of the scoping process, of the steps of the joint clinical assessment, of its update, as well as of its re-initiation under Article 10(7) of Regulation (EU) 2021/2282. The health technology developer should also be informed of the decision of the Coordination Group to include the update of the joint clinical assessment in its annual work programme, pursuant to Article 14 of Regulation (EU) 2021/2282. 

(12) To ensure the effective involvement of individual experts in joint clinical assessment of medical devices, the JCA Subgroup should specify the information necessary for their identification as early as possible, whenever the Coordination Group recommends selecting a medical device for joint clinical assessment. The HTA secretariat should identify individual experts on the basis of that information. 

(13) To identify individual experts with relevant in-depth specialised expertise, the HTA secretariat should be able to consult the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282, the European reference networks for rare and complex diseases and other relevant sources, agencies, and organisations. In order to ensure the highest scientific quality of the joint clinical assessment, in making the final selection, the JCA Subgroup should give priority to individual experts who have expertise, across several Member States, in the medical condition to be treated, therapeutic area, the type of health technology that is the subject of the joint clinical assessment or other specific expertise. These experts should be consulted during the joint clinical assessment. 

(14) To ensure that individual experts take part in joint clinical assessments in an independent and transparent manner, free from conflict of interest, they should only be selected and involved in joint clinical assessments after the Commission has assessed their declared interests, in accordance with Article 5(5) of Regulation (EU) 2021/2282 and with Article 4 of Commission Implementing Regulation (EU) 2024/2745. 

(15) In order to ensure the transparency and appropriate involvement of stakeholder organisations in its work, the JCA Subgroup may give the opportunity to patient organisations, healthcare professional organisations and clinical and learned societies to provide their input on joint clinical assessments. 

(16) To achieve the objective that, during the development of the assessment scope, Member States’ needs are translated in the lowest possible number of sets of parameters for the joint clinical assessment in terms of patient population, intervention, comparators and health outcomes, the assessor, with the assistance of the co-assessor, should prepare an assessment scope proposal that will serve as a basis for Member States to express their needs. 

(17) To ensure that the assessment scope is inclusive and reflects Member States’ needs, the assessment scope proposal prepared by the assessor, with the assistance of the coassessor, should be shared with the members of the JCA Subgroup. 

(18) It should be ensured that the assessment scope is developed respecting the right to good administration and taking into account information provided by the health technology developer and input received from individual experts. 

(19) Deadlines should be set for the finalisation of the assessment scope and of the draft joint clinical assessment reports by the JCA Subgroup with the aim of ensuring the timely availability of joint clinical assessment reports of medical devices. In order to maximise available resources, the assessment scope should only be finalised by the JCA Subgroup after the adoption of the Commission decision referred to in Article 7(4) of Regulation (EU) 2021/2282 selecting the medical device for joint clinical assessment. 

(20) To contribute to the completeness and high quality of the dossier and the smooth conduct of the joint clinical assessment, the health technology developer should be able to request an assessment scope explanation meeting with the JCA Subgroup. 

(21) In order to ensure high quality of the dossier for the joint clinical assessment and of the joint clinical assessment report, as well as to ensure the protection of confidential data for commercial reasons, deadlines should be set giving sufficient time to the health technology developer to prepare and submit that dossier and to take the following actions: (a) provide missing information, data, analysis and other evidence as indicated in the Commission’s second request referred to in Article 10(5) of Regulation (EU) 2021/2282; (b) provide further specifications or additional information, data, analyses, or other evidence as provided for in Article 11(2) of Regulation (EU) 2021/2282; (c) provide updates to previously provided information referred to in Articles 10(8) of Regulation (EU) 2021/2282; (d) signal technical or factual inaccuracies in the draft joint clinical assessment and summary reports and any information considered as confidential. 

(22) In order to ensure good administration and timely availability of joint clinical assessment reports of medical devices, deadlines should be set for the Commission’s assessment on whether the dossier submitted by the health technology developer for joint clinical assessment of the medical device meets the requirements laid down in Article 9(2), (3) and (4), of Regulation (EU) 2021/2282. In order to ensure the smooth conduct of joint clinical assessment, the Commission should consult, as appropriate, the assessor and co-assessor when carrying out the assessment. 

(23) To ensure the highest scientific quality of the joint clinical assessment, individual experts should be involved in the joint clinical assessment process by being given the opportunity to provide input on the draft joint clinical assessment and summary reports. 

(24) Article 11(2) of Regulation (EU) 2021/2282 requires the health technology developer to proactively inform the Coordination Group where new clinical data becomes available during the joint clinical assessment process. In order to ensure, on the one hand, the smooth conduct of the joint clinical assessment and the compliance with the deadlines for the finalisation of the joint clinical assessment report and, on the other hand, legal certainty for the health technology developer, the deadline should be set at a date in which the JCA Subgroup is to ensure that the new clinical data received by that date are considered in the draft joint clinical assessment and summary reports. 

(25) In order to ensure the delivery of joint clinical assessment reports in a timely manner, deadlines should be set for finalising the revised draft joint clinical assessment and summary reports by the JCA Subgroup and for endorsing the revised draft joint clinical assessment and summary reports by the Coordination Group. 

(26) Article 10(7) and Article 14 of Regulation (EU) 2021/2282 provide respectively for the re-initation and update of a joint clinical assessment. In order to ensure the effective application of these provisions, it is necessary to adopt certain detailed procedural rules and deadlines that should apply in those instances. 

(27) In order to ensure transparency, traceability and professional secrecy, as well as to contribute to the procedural compliance of joint clinical assessment reports, any documentation referred to in Regulation (EU) 2021/2282 and this Regulation should be sent in a digital format and should be exchanged during joint clinical assessments of medical devices with and between the Coordination Group, the JCA Subgroup, the HTA secretariat, the health technology developer and individual experts through the IT platform referred to in Article 30 of Regulation (EU) 2021/2282 (‘the HTA IT platform’). 

(28) In order to ensure transparency, on the one hand, and the protection of confidential data for commercial reasons, on the other hand, the joint clinical assessment and the summary reports, together with the documentation referred to in Article 30(3), points (d) and (i), of Regulation (EU) 2021/2282, should be published, after having considered the views of the JCA Subgroup as to the commercially sensitive nature of the information contained in that documentation, which the health technology developer has requested to be treated as confidential. 

(29) This Regulation lays down, in accordance with Article 5(1), point (a), of Regulation (EU) 2018/1725 of the European Parliament and of the Council, the rules for processing of personal data for the purposes of conducting joint clinical assessments of medical devices and their updates. In particular, it specifies the personal data that may be processed, namely certain personal data relating to the individual experts involved in joint clinical assessments and their updates and certain personal data relating to the representatives appointed to the Coordination Group and the JCA Subgroup, the representatives of health technology developers and the representatives of the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282. 

(30) To ensure the processing of personal data for the purposes of conducting joint clinical assessments of medical devices and their updates, the Commission should be considered the controller of that processing within the meaning of Article 3, point (8), of Regulation (EU) 2018/1725. Any processing of personal data by the members of the Coordination Group and the JCA Subgroup and their representatives outside of the HTA IT platform is to take place in accordance with Regulation (EU) 2016/679 of the European Parliament and of the Council. 

(31) The identity of the patient may reveal the patient’s health status in relation to the subject matter of the joint clinical assessment and should therefore be considered a special category of personal data under Article 10 of Regulation (EU) 2018/1725. Such data should only be processed where the criteria set out in Article 10(2), point (i), of that Regulation are met. It is necessary to provide for suitable and specific measures to safeguard the rights and freedoms of the patient. In particular, no personal data of patients should be made publicly available. Moreover, under Article 5(6) of Regulation (EU) 2021/2282, the representatives appointed to the Coordination Group and the JCA Subgroup, as well as individual experts involved in joint clinical assessments and their updates, are subject to a requirement of professional secrecy, even after their duties have ceased. To ensure protection of personal data and of confidential information, it is necessary to provide that only individual experts who have signed confidentiality agreements may be involved in joint clinical assessments and their updates. 

(32) To ensure the possibility to verify whether the joint clinical assessments were conducted in the procedurally compliant manner, notably in the event of complaints or litigation, it is appropriate to provide for a retention period of personal data and for its review at regular intervals. To ensure the relevant in-depth specialised expertise in joint clinical assessment, for example, in the event where the selected individual experts step down from their roles and responsibilities, it is appropriate to provide for a retention period of personal data of individual experts not selected to take part in a joint clinical assessment.

(33) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 15 July 2025. 

(34) The measures provided for in this Regulation are in accordance with the opinion of the committee referred to in Article 33(1) of Regulation (EU) 2021/2282,