Overview
HTA Regulation Implementing Regulation Concerning Joint Scientific Consultations on Medical Devices and IVDs
The European Commission has published an implementing regulation related to the Health Technology Assessment Regulation (HTA Regulation) that concerns joint scientific consultations on medical devices and in vitro diagnostic devices. The purpose of the Regulation is to provide detailed procedural rules for scientific advice in relation to a number of elements, including the submission of related requests from health technology developers and the selection and consultation of stakeholder organisations, patients, clinical, and other relevant experts. The purpose of the scientific advice is to permit health technology developers to exchange information with HTA bodies concerning their plans to develop medical devices or in vitro diagnostic medical devices, and the suitability of these plans for the assessment process for which the HTA Regulation provides. The Regulation also provides for cooperation with the European Medicines Agency (EMA) in joint scientific consultation, paralleled with an expert panel consultation. The purpose of joint scientific consultations is to ensure that both bodies share relevant information and maintain "synchronized timing". It also provides for close coordination between the HTA secretariat and the EMA to avoid procedural duplications and ensure that all required documents are uniformly accessible to both bodies. Lastly, the Regulation provides that each year, the Coordination Group should set dates of request periods for joint scientific consultations by November 30 – and there should be at least three request periods each year. As a derogation from this requirement for 2025, the Coordination Group should set at least one request period for joint scientific consultations on medical devices and in vitro diagnostic medical devices for the year by March 31.
Belgian Health Technology Assessment (HTA Body to Lead Consortium of EU Member State HTA Bodies Carrying Out Joint Clinical Assessments (JCA) under the HTA Regulation.
The Belgian health technology assessment (HTA body), INAMI-RIZIV, will lead the consortium of EU Member State HTA bodies that will carry out joint clinical assessments under the HTA Regulation. The consortium was formed under the guidance of the Heads of the HTA Agencies Group (HAG), which is an independent group of 32 European healthcare agencies working together to advance strategic collaboration on HTA. The consortium will receive a total of €35m under the EU4 Health Program, which is intended to contribute to long-term health challenges by building stronger, more resilient and more accessible health systems. Each agency will be receiving support from the European Commission to correctly perform the assessments.
Q&A Requirements Related to Notified Bodies
The Medical Device Coordination Group (MDCG) recently published an update to its Q&A related to notified bodies' requirements under MDR and IVDR, MDCG 2019-6 Rev5. The purpose of the Q&A is to provide guidance to notified bodies concerning, among other things, the obligations that relate to their designation and operation and how these obligations should be fulfilled. Revision 5 to the Q&A follows the approach of recent updates to other MDCG guidance by providing new and expanded definitions, including the difference between consultancy and regulatory guidance, a subject of debate. The revision includes the addition of questions and answers concerning the operational principles of notified bodies and amplified obligations concerning appropriate personnel qualifications. The section of the Q&A concerning transparency that must exist in relation to the activities of notified bodies has been amplified. New guidance is also provided concerning clinical evaluation and surveillance audits. The Q&A strengthens the procedures concerning verification that technical documentation submitted by legal manufacturers complies with requirements imposed by the Medical Devices Regulation and the in vitro diagnostic medical devices Regulation. It also strengthens post-market surveillance procedures. Changes have also been introduced in Technical Documentation Requirements including a preferred structure for Technical Documents.
Pilot System for Sponsors of Clinical Investigations of Medical Devices
Sponsors of clinical investigations in the EU have been invited to apply to participate in a pilot scheme, introducing a coordinated assessment of clinical investigations and performance studies as provided in Articles 78 of the Medical Device Regulation and Article 74 of the in vitro Diagnostic Medical Devices Regulation. The pilot will permit sponsors to submit a single application for a coordinated assessment and is hoped to lead to the establishment of a harmonized and predictable process across EU Member States, reducing administrative burden for sponsors and ensuring transparency and consistency in the coordinated assessment. Application is limited to medical devices falling within defined classes. These are; for medical investigational devices in Class III, invasive investigational devices in Class IIa, and invasive investigational devices in Class IIb, for IVDs where the conduct of the study involves additional invasive procedures or other risks for the subjects of the studies, or performance studies involving companion diagnostics. Applications for participation in the pilot scheme should be submitted before June 30, 2025.
Commission Publishes Guidelines on the Definition of an Artificial Intelligence System Established by the AI Act
The European Commission has published Guidelines on the definition of an artificial intelligence system established by Regulation (EU) 2024/1689 (AI Act). Article 3(I) of the AI Act defines an artificial intelligence system as having seven elements: a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments. Systems falling within this definition include medical devices considered to be high risk within the scope of the AI Act. The guidelines examine each of the elements from a lifecycle-based perspective, encompassing a pre-deployment phase and a post-deployment, or use, phase. They underline that all seven elements found in the definition of an AI system are not required to be present continuously throughout both phases of that lifecycle, and instead, the guidelines acknowledge that specific elements may appear at one phase, but may not persist across both phases. This approach is intended to define an AI system, to reflect the complexity and diversity of AI systems, and to ensure that the definition aligns with the AI Act's objectives by accommodating a wide range of AI systems.
Certain EU Medical Device Laws Will Not Be Sunsetted in Great Britain on May, 26 2025
The plan to sunset a number of EU medical device laws in Great Britain has been revised following related consultation. It had been expected that four pieces of EU legislation; European Commission Decision 2002/364 (on common technical specifications for in vitro diagnostic medical devices), Regulation 207/2012 (on electronic instructions for use of medical devices), Regulation 722/2012 (concerning particular requirements for medical devices manufactured utilizing tissue of animal origin), and Regulation 920/2013 (on the criteria for designation and supervision of approved bodies under the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Device Directive (90/385/EEC)), would be "sunsetted", i.e., cease to apply in Great Britain starting May 26, 2025. Following the results of a consultation process conducted by the UK Medicines and Healthcare Products Regulatory Agency, (MHRA), it was, however, concluded that these EU laws should now not be sunsetted. Instead, they will be retained “until such time as they are replaced."
All General Animal Safety Tests Abolished
As part of its ongoing process towards the elimination of animal testing from its scope, the European Pharmacopoeia has removed all references to the previous general chapters on pyrogens, histamine, and depressor substances. These chapters related to testing on rabbits, guinea pigs, and cats. These changes will appear in the 12th Edition of the European Pharmacopoeia, which will be published in July 2025, and enter into force in January 2026.
