The complex reviewing process of European Regulation regarding medical devices lead to the EU Regulation 2017/745 on May 2017, with full application from 26 May 2020.
The new regulation sets very articulate dispositions, clearly defining roles and specific responsibilities of various participants in the production chain. There are numerous variations regarding classification rules (especially for medical devices based on substances – Rule 21), compliance evaluation procedures, post marketing surveillance instructions, requirements for clinical data evaluation, identification and traceability tools for medical devices.
The new regulation force companies to identify, within personnel, a person responsible for regulatory compliance who has to be competent in the medical device area. Micro and small enterprises shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
In such a complex frame of news, SAPORITI CONSULTING supports companies on marketing new medical devices, re-classifying procedures according to the new regulation and as person responsible for regulatory compliance, offering: