Medical Device Technical File – EU MDR Annex II

Under EU Regulation 2017/745 (Annex II), the Medical Device Technical File is a structured, comprehensive document prepared by the manufacturer to demonstrate the safety, performance, and regulatory compliance of a device. It must be clear, well-organized, searchable, and free of ambiguity, tailored according to the device’s design, risk class, and intended use.

Key Requirements:

Must be submitted to a Notified Body or Competent Authority for assessment.
Should be prepared preferably in English or an official language of an EU Member State.
Must be maintained and readily available:
- 5 years for Class I (low-risk) devices
- 16 years for Class III and implantable (high-risk) devices

For Non-EU Manufacturers:

The technical file must be held by your European Authorized Representative and made available on request.

Regardless of device class or history of safe use, manufacturers must maintain an up-to-date technical file to demonstrate continuous compliance with the General Safety and Performance Requirements (GSPR) of Annex I.

EU MDR outlines specific documentation requirements for your technical file—ensuring alignment with these standards is essential for CE marking.

Medical Device Technical File – Selection Criteria

Choosing the correct technical file structure is essential for demonstrating compliance with EU MDR and ensuring a smooth path to CE Marking. Yet, many Quality Assurance and Regulatory professionals struggle to determine how many technical files are needed for a product portfolio.

Key Selection Criteria:

When preparing technical files, remember: each file must fully represent one specific device or device family with a common design and intended use. You cannot combine devices with differing characteristics. Consider the following factors:

Intended Use & Indications for Use
Clearly define the medical purpose and scope of each device.
Site of Application
Different anatomical targets may require separate technical files.
Design & Construction Differences
Major variations in design, materials, or construction warrant separate documentation.
State of the Art
Align each file with current industry standards, technology, and safety benchmarks.
EMDN / GMDN Codes
Ensure proper classification and consistency with European databases and nomenclature systems.

Medical Device Technical File Consultants – RAPS

With the introduction of EU MDR 2017/745, the requirements for medical device technical documentation have become significantly more detailed and demanding than those under the former MDD. Partnering with knowledgeable and experienced consultants can be the key to ensuring a smooth, compliant, and efficient submission process.

Why Work with RAPS Consultants?

Our expert consulting team understands the nuances of EU MDR and provides end-to-end support for preparing a fully compliant technical file. Here’s how we add value:

Accelerated Documentation Process
We use proven templates, tools, and checklists to streamline your file preparation, reduce turnaround time, and avoid common pitfalls—ensuring faster Notified Body approval.
Robust Risk Management Alignment
Our specialists ensure your risk management files meet both ISO 14971 and EU MDR requirements, leaving no gaps in your documentation.
PMS Integration
We help you establish and align Post-Market Surveillance (PMS) systems and reports with your technical file—essential for lifecycle compliance.
Clinical Evaluation Expertise
Our trained clinical writers produce comprehensive, MDR-compliant Clinical Evaluation Reports (CERs) aligned with Article 61 and MEDDEV 2.7/1 Rev. 4 standards.

Key Benefit:

Outsourcing your technical documentation to RAPS allows you to focus internal resources on what matters most—product development and innovation—while we ensure every regulatory detail is handled with precision.

Medical Device Technical File – EU MDR Annex II

Key Requirements:

Key Selection Criteria:

Why Work with RAPS Consultants?

Key Benefit:

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