All the manufacturers of medical devices have set up a quality system in order to be in compliance with the regulatory requirements of the EC Directive 93/42. With the entry in force of the Regulation 745/2017 the quality systems should be updated to include the new regulatory requirements.
It will not be necessary to completely change the quality system (the reference technical standard will still be the ISO 13485) but the quality system must be updated to include, at least:
- The role of the “Person Responsible for Regulatory Compliance”
- The new definition of “incident” and the new reporting time
- The new requirements as concerns post marketing surveillance that include PSUR, PMS plan and PMCF plan
- The EUDAMED registration requirements
- The UDI requirements
To implement all the above, new SOPs may be required, existing SOPs could be updated, quality manual should be revised and personnel involved in the medical device workflow should be adequately trained.
The quality system update is strongly recommended as all the manufacturers, regardless of the regulatory status of their medical devices, starting from 26th May 2020, must follow the new regulation and comply with its requirements at least as regards the aspects of vigilance, surveillance, traceability and registration.
Updating a quality system is never a simple thing and it requires great efforts and great attention given the direct impact on workflows; companies should start planning the changes to be made as soon as possible.
Don’t get caught unprepared!
Regulatory Pharma Net is at your disposal to offer you support to better manage the transition from the current directive to the new regulation.