(fra kommisjonsbeslutningen)

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

(2) Pursuant to Article 3(2) of Commission Implementing Regulation (EU) 2024/2699, the European Medicines Agency is to provide, no later than 15 days after the end of the quarter concerned, the Commission acting as secretariat of the Coordination Group (‘the HTA secretariat’) with information on all medical devices and in vitro diagnostic medical devices for which the expert panels provided a scientific opinion or their views in the framework of the clinical evaluation consultation procedure (‘CECP’) pursuant to Article 54 of Regulation (EU) 2017/745 or the performance evaluation consultation procedure pursuant to Article 48(6) of Regulation (EU) 2017/746 of the European Parliament and of the Council. For the first reporting period, the European Medicines Agency was to provide that information covering the period from 1 January 2024. 

(3) Pursuant to Article 4(2) of Implementing Regulation (EU) 2024/2699, the HTA secretariat is to make that information available to the Coordination Group’s subgroup on joint clinical assessments (‘the JCA Subgroup’) for further analysis in the preparation of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282.

(4) On 15 April 2025, 15 July 2025, 15 October 2025, 15 January 2026 and 17 April 2026, the European Medicines Agency provided the HTA secretariat with information on all medical devices and in vitro diagnostic medical devices for which the expert panels provided a scientific opinion or their views during the period from 1 January 2024 to 31 March 2026. The HTA secretariat made that information available to the JCA Subgroup for further analysis in the preparation of the recommendation referred to in Article 7(4) of Regulation (EU) 2021/2282. 

(5) Based on the analysis of the JCA Subgroup, on 22 June 2026, the Coordination Group recommended that the Commission select for joint clinical assessment the medical devices under the names SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM with CECP dossier No EMA/EX/0000242967 and HIGHLIFE TRANS-SEPTAL MITRAL VALVE REPLACEMENT SYSTEM with CECP dossier No EMA/EX/0000309556. 

(6) The medical devices and in vitro diagnostic medical devices are to be selected for joint clinical assessment based on one or more of the criteria listed in points (a) to (f) of Article 7(4) of Regulation (EU) 2021/2282, namely, unmet medical needs, first in class, potential impact on patients, public health or healthcare systems, incorporation of software using artificial intelligence, machine learning technologies or algorithms, significant cross-border dimension and major Union-wide added value. 

(7) Both medical devices recommended by the Coordination Group comply with the criteria listed in Article 7(4), points (a), (b), (c), (e) and (f), of Regulation (EU) 2021/2282. 

(8) In particular, the medical device under the name SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM addresses an unmet medical need for the treatment of symptomatic moderate-to-severe or severe mitral regurgitation in patients who are deemed by a heart team unsuitable for surgery or transcatheter edgeto-edge therapy. The medical device is first in class, as currently there is no equivalent medical device with the same mechanism of action or technological approach available on the market for the same medical indication. That medical device is designed to lead to improvements in patients’ survival, morbidity, and quality of life. Therefore, it could have a potential impact on patients, public health and healthcare systems. Furthermore, the medical device is within the remit of the decision-making bodies for health technology assessment of several Member States that confirmed that a joint clinical assessment of that medical device carried out at Union level would add value and achieve its objectives better than a clinical assessment carried out at Member State level. 

(9) On the day that the Coordination Group adopted its recommendation, all certificates of conformity had already been issued for the placing on the market of the medical device under the name SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM. There is therefore a risk of potential duplication of clinical assessments taking place both at Union and Member State levels. However, the Coordination Group explained that that risk was mitigated in the case of that medical device, as only one Member State had declared an ongoing assessment at national level of that device, while several other Member States had confirmed that a joint clinical assessment carried out at Union level would add value and achieve its objectives better than the work carried out at the level of that Member State. 

(10) The medical device under the name HIGHLIFE TRANS-SEPTAL MITRAL VALVE REPLACEMENT SYSTEM addresses an unmet medical need for the treatment of moderate-to-severe or severe mitral valve regurgitation due to primary (i.e. degenerative), secondary (i.e. functional) or both primary and secondary mitral valve regurgitation in patients with left ventricular ejection fraction ≥ 30 % and left ventricular end-diastolic dimension ≤ 70 mm who do not have severe mitral annular calcification and are deemed by a multi-disciplinary heart team unsuitable for surgical repair/replacement or transcatheter edge-to-edge repair. The medical device is first in class as currently there is no equivalent medical device with the same mechanism of action or technological approach available on the market for the same medical indication. That medical device is designed to lead to improvements in patients’ survival, morbidity, and quality of life. Therefore, it could have a potential impact on patients, public health and healthcare systems. Furthermore, the medical device is within the remit of the decision-making bodies for health technology assessment of several Member States that confirmed that a joint clinical assessment of the medical device carried out at Union level would add value and achieve its objectives better than a clinical assessment carried out at Member State level. 

(11) On the day that the Coordination Group adopted its recommendation, all certificates of conformity had already been issued for the placing on the market of the medical device under the name HIGHLIFE TRANS-SEPTAL MITRAL VALVE REPLACEMENT SYSTEM. There is therefore a risk of potential duplication of clinical assessments taking place both at Union and Member State levels. However, the Coordination Group explained that that risk was mitigated in the case of that medical device, as only one Member State had declared an ongoing assessment at national level of the device, while several other Member States had confirmed that a joint clinical assessment carried out at Union level would add value and achieve its objectives better than the work carried out at the level of that Member State. 

(12) The recommendation of the Coordination Group aligns with the Commission’s response to cardiovascular health as the Union’s leading public health challenge. Specifically, joint clinical assessments of cardiovascular medical devices, including cardiac valves, are expected to help Member States make fast and informed decisions on the pricing and reimbursement of those medical devices. 

(13) It is therefore appropriate to follow the recommendation of the Coordination Group and to select the medical devices under the names SAPIEN M3 TRANSCATHETER MITRAL VALVE REPLACEMENT SYSTEM and HIGHLIFE TRANS-SEPTAL MITRAL VALVE REPLACEMENT SYSTEM for joint clinical assessment. 

(14) The measures provided for in this Decision are in accordance with the opinion of the Committee on Health Technology Assessment established by Article 33(1) of Regulation (EU) 2021/2282,