In about one year the new European regulation on medical devices, European Regulation 745/2017, will be reality and the new requirements will become mandatory and applicable to all medical devices and to all companies operating in the medical device field.
Although 1 year may sound like a very long time, the truth is that the time is short, and you need to know what are the main changes and what impact they may have on products and company activities.
A brief list of the main news of the European Regulation 745/2017 is reported below:
- New obligations for manufacturers, importers, distributors
- New rules and requirements for clinical evaluation
- Additional information to be provided on substance-based devices in the technical file
- New classification rules for
- devices containing substances
- softwares
- nano-materials
- active medical devices
- New definitions of “incidents” with medical device
- Introduction of the “Person responsible for regulatory compliance”
- New requirements on traceability (i.e. UDI system)
- New vigilance and post-marketing surveillance activities and duties, such as:
- Preparation of PSURs for class II and class III MDs
- Implementation of a Post-Marketing Clinical Follow Up Plan (PMCF Plan)
- Implementation of a Post-Marketing Surveillance Plan (PMS Plan)
- New Essential Requirements List
- New requirements for clinical investigations with Medical Devices
- New traceability requirements
On the basis of these points, each company should make an internal evaluation of its quality system and the technical files of its medical devices, to check if, how, when and where apply changes in order to be ready for the entry into force of the new regulation, avoiding any unpleasant surprises.
Don’t get caught unprepared!
Regulatory Pharma Net is available to offer support to better manage the transition from the current directive to the new regulation.