Medical Devices Regulation (MDR)
The European Union has strict regulations for medical devices, to protect the health and safety of its citizens. The European requirements are different than those in application elsewhere, notably to those of FDA in the USA. Manufacturers of medical devices need to comply with these obligations, if they wish to access the huge European market.
Until 2021, the regulations in place were covered by the Medical Devices Directive (MDD). Some medical devices accredited before 2021 are still under MDD, but for limited time, they will need to evolve to the new regulations. Since May 2021, MDD has been replaced by the Medical Devices Regulation (MDR), harmonising the rules for the placing on the European Union market of medical devices. MDR also applies to clinical investigations concerning medical devices.
MDR defines among other important items :
• what is a medical device or accessory (a medical software can be, or not, a medical device) ;
• the obligations and procedure of registration of the manufacturer ;
• the necessity for non-European manufacturers to mandate their European representative, like Medicina Legatis ;
• the obligations of importers, distributors and notified bodies ;
• the rule to appoint a Person Responsible for Regulatory Compliance (PRRC - for non-European manufacturers, your European representative like Medicina Legatis will provide you this competence) ;
• the obligations of declaration of conformity, of CE-marking, of Unique Device Identification (UDI) and the organization of the European database on medical devices (Eudamed) ;
• the organization of clinical investigations ;
• the post-market surveillance, vigilance and market surveillance ;
• the confidentiality and data protection obligations.
The complete MDR is accessible on the official website of the European Union : https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745