Technical Documentation to Comply with the MDR and IVDR
Before placing a medical device on the European market, manufacturers need to produce technical documentation providing evidence of conformity with the relevant legislation.
From the 26 May 2020, technical documentation needs to comply with the Medical Device Regulation (MDR) (EU) Regulation 2017/745. Manufacturers’ who already have products on the market under the MDD (Medical Device Directive) or AIMDD (Active Implantable Medical Device Directive) who wish to obtain or renew a CE certificate or issue a Declaration of Conformity (DoC), will eventually have to revise their technical documentation to comply with the MDR at the latest by 27 May 2024.
Furthermore, manufacturers of In-Vitro Diagnostic Devices will also need to revise their technical documentation to comply with the In-Vitro Diagnostic Regulation (IVDR) (EU) Regulation 2017/746 by the 26 May 2022.
The new MDR and IVDR impacts manufacturers, stakeholders, Competent Authorities (CAs) and Notified Bodies (NBs) on how the technical documentation should be developed and maintained. The requirements have been raised and will be subject to more scrutiny by the CA and NB.
This seminar will provide essential guidance on the content of the technical documentation file, the changes required and the practicalities of compiling and maintaining the technical file to comply with the MDR and IVDR. Our expert trainers will guide you through the requirements and give you practical advice on how to manage the life cycle of the technical file.