High-risk medical devices in Europe: new methods of evaluation through CORE-MD project
CORE-MD (Coordinating Research and Evidence for Medical Devices) is a Horizon 2020, EU-funded project with the aim of enriching the EU regulatory guidance documents with expert knowledge on medical devices and building expertise in the field of regulatory science.
The project is led by the European Society of Cardiology (ESC), in collaboration with the European Federation of National Associations of Orthopedics and Traumatology (EFFORT), and involves 35 specialist medical associations, which are members of the Biomedical Alliance in Europe.
With the entry into force of the MDR on May 26, 2021, the requirements for clinical evidence on high-risk medical devices have increased, raising concerns among the medical device developers on possible market access delays and on the stalling of innovation.
It is estimated that more than 50% of high-risk implantable medical devices in Europe, including heart valves and hip replacements, are used in cardiology and orthopedics. These areas will be the focus point of the CORE-MD project. Particularly, the latter involves:
- The systematic review of methodologies for the clinical investigation and evaluation of high-risk medical devices;
- Recommendations on new trial designs;
- Advice on how to extract maximum value from real-word data evidence, including medical device registries and clinical practice;
- Multidisciplinary workshops with a focus on evidence from clinical investigations;
- Educational and training objectives for all stakeholders to gain expertise in the field of regulatory science in Europe;
- An ethics charter for medical device innovation.
The recommendations from the CORE-MD consortium will be evaluated by the European Commission Working Group on Clinical Investigation and Evaluation, which may be used as a basis for the development of new EU guidance documents and common specifications.
The CORE-MD will guarantee an increased transparency of medical standards based on scientific and clinical evidence. Furthermore, a new balance between innovation, safety, efficacy and cost-effectiveness of high-risk medical devices is expected to be achieved, improving the benefit/risk ratio for patients.
Giorgia de Stefano
Regulatory Affairs Department
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- European Society of Cardiology (2021). Coordinating Research and Evidence for Medical Devices (CORE-MD). Retrieved on 15.06.2021 from: https://www.escardio.org/The-ESC/Advocacy/coordinating-research-and-evidence-for-medical-devices
- ESC Press Office & EFFORT (2021). EU assessment of high-risk medical devices faces in-depth review. Retrieved on 15.06.2021 from https://www.team-nb.org/wp-content/uploads/2021/04/CORE-MD_press_release_-13April-2021_FINAL.pdf