On 7th November, the experts involved in CORE-MD took part in the workshop organised by the EU WG Clinical Investigation and Evaluation (CIE). The aim of the meeting was to present to the European regulators the initial results of CORE-MD and reflect on the current challenges derived from the implementation of the Medical Devices Regulation.
The workshop addressed three main issues that the CORE-MD partners were working on:
- Methods used to generate clinical evidence for high-risk medical devices
- Regulatory standards for the clinical evaluation of high-risk devices
- Clinical evaluation of artificial intelligence medical devices
Prof. Alan Fraser presented the rationale underpinning the CORE-MD, its objectives as well as the different partners involved in this EU-Funded project. He notably stressed that after 18 months of hard work, partners were able to share preliminary results.
- clinical evidence for high-risk medical devices
Prof. Anne Luebekke reported on the outcome of their systematic review on Clinical investigations to evaluate high-risk orthopaedic devices. While the preliminary manuscript of the systematic review had already been drafted, two other papers were being elaborated consisting in two meta-analysis of randomly selected hip and knee arthroplasty implants. The focus of WP 1 was on the revision rates in registry reports and published literature.
Dr Perla J. Marang-van de Mheen presented the work done on the quality of registries for post-market surveillance of orthopaedic devices. She referred to the paper presenting the systematic review of European cardiovascular and orthopaedic registries for the regulatory evaluation of medical device safety and performance across the implant lifecycle. In this regard, the preliminary results were that European orthopedic registries need better reporting on variables related to the design and methods used, and agreement on definitions and outcomes, to achieve their potential as a reliable data source for regulatory purposes.
She also presented the extent to which hip and knee implants with high Orthopaedic Data evaluation panel (ODEP)-ratings have better revision percentages than similar implants with lower ODEP-ratings. According to the study, Hip implants with higher and lower ODEP-ratings had similar revision risks. To improve benchmarking with ODEP-ratings, more consistent reporting of implants by registries and ODEP were needed.
- Regulatory standards for the clinical evaluation
Petra Schnell-Inderst referred to the strength, weaknesses and gaps in recommendations on methodology of design of confirmatory pivotal clinical trials for high-risk medical devices. The literature review included recommendations from Regulators, national and transnational (High income countries: EU, EFTA, UK, USA, Canada, AUS, Japan), International standardisation organisations, Health technology agencies, Medical professional associations and Academic research. She notably pointed to the difference and lack of homogeneity between the different regulatory standards for the clinical evaluation of high-risk medical devices.
- Clinical evaluation of artificial intelligence
Prof. Alan Fraser presented the different regulatory initiatives that have emerged to fill a perceived gap in guidance for evaluating AI robustly from a clinical perspective. Most recommendation proposed a staged approach to evaluating AI through several preclinical and clinical assessment steps.
Prof. Frank Rademaker presented the underlying principles for the clinical evaluation of AI and stand-alone software in medical device developed by CORE-MD partners.
Representatives from regulators welcomed the update on this project and its input to the current challenge that implementation of the Medical Device Regulation represents. They outlined the importance of expert views on the required level of evidence for various high risk medical devices for their regulatory role in assessing the safety and quality of medical devices.