Technical documentation for medical devices within the scope of the MDR
Compliance with the Medical Device Regulation (MDR) is essential for medical device manufacturers who want to market their products in the EU or EEA. An important part of this is the creation of comprehensive technical documentation, which manufacturers use to prove the conformity of their products with these specifications.
Why technical documentation is essential for you
The MDR explicitly requires the preparation of technical documentation in its Annex II and also specifies the contents there. Technical documentation is thus a central component of the MDR and must contain all relevant information about a medical device. It includes, among other things, documents on technical specifications, design and manufacture, instructions for use and intended use. It also includes a comprehensive risk analysis and clinical evaluation to document the safety and efficacy of the product. In this respect, the technical documentation serves as proof of compliance with the essential safety and performance requirements of the MDR and is of central importance.
How your technical documentation is structured
The structure of the technical documentation is crucial for its comprehensibility and usability. The MDR requires that the documentation be clearly structured and contains all required sections of Annex II. This includes, among other things, a summary of the product and it’s intended purpose, target group and characteristics, a description of the areas of application and design, as well as a risk analysis, a clinical evaluation and information on conformity with relevant norms and standards.
Regular revision to ensure up-to-dateness
The Technical Documentation must be regularly reviewed and updated to ensure that it remains up-to-date and complies with the requirements of the MDR. Revision and updating may be required due to changes in the design or use of the device, new findings from clinical studies, or new requirements of the MDR. Companies should ensure that they have a clear process for revising and updating technical documentation to ensure that it is always up to date.
Ensure long-term success
Technical documentation is an important component of MDR compliance and a critical factor in the long-term success of medical devices. Companies that fail to comply with MDR requirements risk not only the safety and efficacy of their products, but also serious legal consequences.
How Medicoforum supports you
Because we maintain certification ourselves and manage several technical documentations in-house, we have over 20 years of first-hand experience. As an experienced consultant or service provider, we can help you set up and maintain MDR-compliant technical documentation and support you with our expertise.
