The technical documentation for your medical device is far more than a regulatory requirement – it is the primary evidence of your product's safety and performance. Your technical documentation serves as the basis for conformity assessment under Medical Device Regulation (EU) 2017/745 (MDR), ensures CE marking, and secures both your market access and long-term market presence.With your technical documentation, you – as the manufacturer of a medical device – demonstrate its compliance with the applicable regulations for each target market. Moreover, it provides proof of meeting the General Safety and Performance Requirements (GSPR) necessary to obtain the European CE marking, which is essential for product approval in your target markets.Throughout the product's entire lifecycle, but at least for ten years after the last product is placed on the market (fifteen years for implants), the technical documentation must be available for review by the regulatory authorities. It not only serves as proof of product compliance but also as a valuable tool for ensuring the quality and safety of the medical device.
In a non-binding initial consultation, we’ll help you assess where you are on your regulatory journey. Contact us today!
In a non-binding initial consultation, we’ll help you assess where you are on your regulatory journey. Contact us today!
Our services for your technical documentation
- Creation and Maintenance: We can handle the complete creation of your documentation or support you in updating your existing files.
- Regulatory Compliance: Implementation of the requirements from MDR, EN 60601-1, EN ISO 10993-1, EN 62304, EN 62366, and other relevant standards.
- Risk Management & Usability: Integration of risk management (ISO 14971) and usability engineering (IEC 62366-1) into your documentation.
- Efficient Structure: Optimization of content for clear traceability – from product descriptions to verification plans and lifespan analyses.
- Market Access & International Requirements: Support with the approval process for medical devices in the EU and worldwide.
Do you want to ensure your technical documentation meets current regulatory requirements?
Contact us! We offer tailored advice and help you implement the requirements successfully.
What should be included in technical documentation?
The regulatory requirements for technical documentation are detailed and comprehensive. The documentation must contain all essential information about the medical device, including:
technical product information,
all development details,
manufacturing information,
verification data,
validation data, and
information on the product's application.A word of warning: Incomplete or incorrect technical documentation can delay the conformity assessment and approval process – and may also lead to legal risks for you as the manufacturer!Meet regulatory requirements and stay on the safe side: A conversation with us can provide clarity – contact us!
technical product information,
all development details,
manufacturing information,
verification data,
validation data, and
information on the product's application.A word of warning: Incomplete or incorrect technical documentation can delay the conformity assessment and approval process – and may also lead to legal risks for you as the manufacturer!Meet regulatory requirements and stay on the safe side: A conversation with us can provide clarity – contact us!
Medical engineers, computer scientists, physicists, and biologists: We are experts and all-rounders – and for sure exactly what you need.
Secure the future of your medical devices: transition to MDR-compliant technical documentation
Have you already transitioned your technical documentation to comply with (EU) 2017/745 (MDR)? The MDR came into force in 2017, and soon the last transition periods for your medical devices will expire. It is crucial that you act promptly to continue ensuring high quality and safety of your products. Our whitepaper series provides you with valuable best practices for transitioning your existing products. Use these as a conceptual framework for your detailed work and ensure that your products meet the new requirements. Act now and stay successful in the market!
(Available only in German Language)Download our whitepaper for free now.
(Available only in German Language)Download our whitepaper for free now.
Global regulatory requirements and market access for your medical device
Regulatory requirements differ significantly depending on the target market. While the MDR is crucial for CE marking in the European Union, other markets have additional requirements:
- USA – FDA approval under 21 CFR Part 820,
- United Kingdom – UKCA marking as a replacement for CE,
- China – CFDA approval with specific testing requirements,
- Japan – PMDA regulations for market access,
- Australia – TGA conformity for MedTech products.
Metecon: Your partner for compliant technical documentation
As an experienced partner, we support you in creating, maintaining, and optimizing your technical documentation – from development to post-market surveillance:
- Tailored advice on the optimal documentation strategy,
- Efficient document creation in line with all regulatory requirements,
- Gap analysis for existing documentation with actionable recommendations,
- Support during audits and communication with notified bodies.
Get to know us in a non-binding initial consultation!
