The quality and safety of medical devices ensured by a better control of the market and stricter rules in general convinced Swiss legislator will promptly follow the future EU regulatory framework on medical devices (MDR/IVDR). The alignment is also required by the signature of the agreement between the EU and Switzerland on the mutual recognition of conformity assessments.
Both Switzerland and the EU consider the following points crucial to improving patients’ safety and preventing scandals related to defective breast implants and hip prostheses that happened in the past:
· Change in risk classification system of devices
· Stricter requirements for higher risk class devices (clinical evaluation, clinical investigations)
· Full traceability of medical devices circulating on both markets
· Access of EU and Swiss competent authorities to the European medical devices databases
· Easier access of patients to relevant information related to the medical device
Switzerland expects to adapt and align its legislation by 2020 – the year the EU MDR becomes applicable!
Do not hesitate to contact us if you wish to know more about the new EU regulatory framework, or you intend to market your devices on the EU market! Obelis experts with more than 30 years of experience will gladly assist you!