Wellspect is in the process of converting its product documentation - the Technical files - to meet the new EU Regulation for Medical Devices. This regulation replaces the earlier directive, leaving no room for ambiguous interpretation.
Ann-Charlotte Ryrman is head of Technical Product Management, the department that manages Wellspect’s Technical files, and is leading the regional initiative to ensure compliance with the new regulation.
The regulation is compulsory for all medical products sold in the EU, and the standard is the same for each European country. This will ensure an overall higher safety standard that places the user at the heart of the new regulation.
It all results in requirements and higher standards of clinical studies. For instance - it is no longer acceptable to use results from other companies as a basis for documentation.
Instructions For Use documents are also subject to increased scrutiny - for instance, there is now a demand to encompass the entire user cycle to include warnings and potential differences between product models. This will support correct and independent use, ensuring the safety and health of the user when healthcare professionals are not present. Improved legibility for symbols that indicate the sterile barriers support the user in the correct handling of the product without jeopardising sterility.
The regulation also demands:
- Strict adaptation of REACH
- A risk-based approach
- Increased level of biocompatibility tests
- Requirements on used hazardous substances
- Post Market Surveillance plans
All of these requirements support and enhance user safety.
Ann-Charlotte also sees some benefits for the environment; with standardised documentation, the Notified Bodies can perform intensive audits remotely, leading to less travel. Higher efficiency means reduced cost, which is another important objective for the health sector in general.
There has been a great effort by a cross-functional team to meet the requirements of the new regulation.
We are confident that the new standard has been enacted and that our documentation adheres to the new requirements, with the benefit of increased efficiency in our collaborations.
Head of Technical Product Management at R&D
We are proud that we’ve been able to swiftly reflect this standardisation within the industry and ultimately benefit the users of medical products.