IVDR
Several devices not covered by the previous Medical Device Directive (MDD) requirements now fall under the MDR requirements, and in many cases, the devices need to be re-classified.
MDR will replace the existing Medical Device Directive (92/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The main reason for MDR is to ensure high standards of quality and safety for medical devices being produced in or supplied into Europe.
The regulation holds several new requirements that must be adhered to:
- Implementation of a Quality Management System, with a Conformity Assessment
- New classification system supported by the Conformity Assessment
- Requirements for CE marking on the device supported by technical documentation
- Compliance with reporting of clinical investigations and post-market surveillance requirements
- Appointing an Authorized Representative that is responsible for regulatory compliance
Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to May 26, 2022 to meet the requirements of the IVDR.
Reliant can offer a scalable turn-key solution and services that will enable small and medium-sized medical device companies to comply with the new regulations listed above.
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