By May 2020 medical devices companies will have to comply with the new EU Medical Device Regulation (MDR). For Vitro Medical Devices (IVMD) the date is May 2022.
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
In cooperation with MyBlueLabel, Pharma IT can now offer a turn-key solution and services that will enable small and medium size medical device companies to comply with new regulations listed above.
Larger or more complex medical devices companies, pharmaceutical companies and biotech companies might benefit from other solutions, as such Pharma IT work as an agnostic system advisor.
The Pharma IT turn-key solution and services can be delivered individually or as a package deal. In this article we have listed the minimum required effort to implement our solution assuming companies will do more work on their own, but additional services can be provided by Pharma IT on an ad-hoc basis, see figure below.