3 May 2021
Clinical research with medical devices
With the entry into force of the revised Swiss medical device law on 26 May 26 2021, important changes for the development and bringing to market of medical devices will result.
Overview of most important changes:
- The definition of medical devices is significantly broader, so that, for example, software applications used in everyday medical practice can also be considered medical devices.
- Products without a medical purpose are now also considered medical devices if they are used in the same way as medical devices or pose comparable risks. This applies, for example, to colored contact lenses without vision correction (eyeglasses). Likewise, products which consist of a combination of a medicinal product and a medical device, such as a disposable syringe.
- The entire life cycle of a medical device is now regulated. This means, among other things, that manufacturers not only have to provide scientifically sound evidence of the safety and quality of their products prior to marketing authorization. Data must also be collected after the product has been placed on the market.
- The approval and monitoring of clinical trials and performance tests have been tightened. Manufacturers must conduct more detailed clinical evaluations, often with their own clinical trials, for all products than before.
- More products must be tested by a conformity assessment body to enter the market.
- The intended purpose of a medical device is becoming more important. It is decisive for the classification of the product.
- Many medical devices are being reclassified, which in turn has an impact on the requirements for technical documentation.
- During the clinical evaluation, extensive technical documentation is prepared.
- This includes a clinical evaluation for the risk-benefit ratio assessment.
- Post-market surveillance is also an essential part of the clinical evaluation.
- There are two types of clinical trials. The term intervention has been replaced with:
- (Non-Compliant) clinical trial: "Systematic investigation of a device involving human subjects and conducted for the purpose of evaluating the safety or performance of the device" - does not serve the purpose of marketing authorization, usually Investigator-Initiated Clinical Trials.
- Conformity-related clinical trial: "Clinical trial conducted to demonstrate the conformity of the product under investigation" - does not serve the purpose of market authorization / CE certificate.
- The submission procedure to Swissmedic and swissethics, on the other hand, has changed in that new deadlines and stricter requirements apply to the quality of the documents and dossiers to be submitted. BASEC, the portal for submission to ethics committees has been adapted for submission. A new protocol template for medical devices is also now available on the swissethics homepage.
- For the benefit of traceability and transparency, all medical devices will receive a unique identifier, a so-called Unique Device Identification (UDI).
- This number, as well as data on the performance and safety of the products, will be recorded in a central European database called EUDAMED. The majority of the data is expected to be publicly available in 2022.
Backgound information in expert videos
recorded at the DKF Clinical Research Update Seminar on 10 March 2021
(in German only)
Hintergründe zur europäischen Medical Device Regulation (MDR)
Prof. Roger Abächerli, PhD, Institut für Medizintechnik, Hochschule Luzern, Referent und Trainer TüV Süd Akademie
Die MDR und ihre Implikationen für die klinische Forschung in der Schweiz
Claudia Becherer, DAS, Teamleiterin Regulatorik, Departement Klinische Forschung (DKF), Universität Basel
Die Umsetzung der MDR im klinischen Forschungsalltag
Daniela Penn, Clinical Research Manager, Regulatory Affairs Manager, Quality Manager, medXteam GmbH Neustadt an der Weinstrasse
Entwicklung von Medical Device Software in der Praxis
Prof. Phillippe C. Cattin, Leiter Departement Biomedical Engeneering (DBE), Universität Basel
Services des DKF für Forschungsprojekte mit Medical Devices
Roland John, Teamleiter Quality Affairs, Departement Klinische Forschung (DKF), Universität Basel