MDR Technical Documentation also known as the technical file or technical dossier is a comprehensive set of documents required under EU MDR 2017/745 to demonstrate that a medical device complies with all applicable General Safety and Performance Requirements (GSPRs). It serves as proof of conformity and is essential for CE Marking.

This documentation must be maintained throughout the lifecycle of the device and made available for inspection by Notified Bodies and Competent Authorities when requested. The structure and content are defined in Annex II.

Properly prepared MDR Technical Documentation should include:

Whether you’re introducing a new device or transitioning from MDD to MDR, ensuring your technical documentation is complete, consistent, and aligned with current regulations is a critical step in achieving CE Marking.

The European Union’s Medical Device Regulation (EU MDR 2017/745) defines strict requirements for technical documentation in Annex II and Annex III, covering both pre-market compliance and post-market responsibilities. Proper Technical documentation is critical for NB approval and final onsite inspection and CE Certification.

Annex II: Technical Documentation

Annex II defines the structure for technical documentation needed for initial conformity assessment and CE Marking:

• Device Description and Specification – Detailed description of the device, variants, accessories, and intended use, including UDI info.

• Information on Design and Manufacturing – Clear documentation of the design stages, manufacturing processes, and quality control procedures.

• General Safety and Performance Requirements (GSPR) – A comprehensive checklist with evidence demonstrating compliance with all relevant GSPR items.

• Risk Management and Benefit-Risk Analysis – Conducted per ISO 14971, showing how risks are identified, mitigated, and justified.

• Clinical Evaluation Report (CER) –A critical component that evaluates clinical data (literature, studies, PMCF) to prove device safety and performance. It must be continuously updated and aligned with MDR Annex XIV Part A.

• Product Verification and Validation – Including software validation, biocompatibility testing, sterilization, usability, electrical safety, and performance testing.

• Labelling and Instructions for Use (IFU) – Samples of product labels and IFUs, translated appropriately, as part of regulatory review.

Annex III: Post-Market Surveillance (PMS)

Annex III outlines documentation for ongoing surveillance once the device is on the market:

• PMS Plan – A structured plan to collect and assess post-market data throughout the device lifecycle.

• Periodic Safety Update Report (PSUR) – Required for Class IIa and above, summarising post-market findings and actions taken.

• Post-Market Clinical Follow-up (PMCF) Plan and Report – An extension of clinical evaluation, gathering ongoing real-world evidence to confirm long-term performance and safety.

Having a compliant and well-organized MDR Technical Documentation, including a strong Clinical Evaluation, is essential to obtain and maintain CE Marking under EU MDR.

While doing a design and development Verification and the validation process is important. Design verification is carried out according to the planned and documented arrangements to ensure that the design and development outputs meet the design and development input requirements. Validation is performed in accordance with the planned & documented arrangements to ensure that the resulting product is capable of meeting the requirements for the intended use.

In this section of verification and validation covers all test done on device to prove its safety and performance, such as: Biocompatibility, safety regarding chemical components, electrical safety, stability, when stored under prescribed condition, sterility, any other test that prove performance of the device, clinical investigation etc. The protocols or plans, as well as the results of these tests, are the documentation for these pre-clinical data that must be attached. Clinical data, which can be obtained by clinical evaluation or clinical investigation, is important in addition to pre-clinical data. A clinical evaluation is used to evaluate and analyse clinical data relating to a medical device in order to provide evidence of the product’s clinical safety and performance.