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IMPORTANCE OF THE TECHNICAL DOCUMENTATION

Technical Documentation Requirements of the new MDR (EU 2017/745)

With the entrance in force of the new MDR (EU 2017/745), manufacturers of medical devices shall update their technical documentation till May 2020, to comply with the new requirements. There is no grandfathering for the devices on the market. This means, that medical devices requiring a CE certificate will need to have recertified against the MDR by a NB, otherwise they will loose their CE marking at latest in 2024.

The requirements for technical documentation are given mainly in Annexes II and III of the MDR.

  • Annex II: Technical Documentation
  • Annex III: Technical Documentation on Post Market Surveillance

Within the medical device directives (MDD 93/42/EEC, AIMD 90/385/EEC) the content of technical file was not very clearly defined, and manufacturers often relied on NB-MED recommendation NB-MED/2.5.1Rec5. But MDR now provides, in Annexes II and III, detailed requirements for the minimum content of technical documentation, together with a specific structure. Therefore, medical device manufacturers should use these annexes during their transition planning to ensure compliance with the new legislation.

According to Article 10 of the MDR ‘technical documentation shall be such as to allow the conformity of the device with the requirements of this regulation to be assessed’. It is always the manufacturer’s responsibility to keep the technical documentation in an auditable form. Furthermore, technical documentation must be updated as applicable during the lifetime of the device, to reflect the current status of the device and provide objective evidence for product safety.

As per Annex II of the MDR, the content of the technical documentation shall include;

  • Device description and specification, including variants and accessories
    • Device description and specification
    • Reference to previous and similar generations of the device
  • Information to be supplied by the manufacturer
  • Design and manufacturing information
  • General safety and performance requirements
  • Benefit–risk analysis and risk management
  • Product verification and validation
    • Pre-clinical and clinical data
    • Additional information required in specific cases

Don’t forget; in all conformity assessment procedures involving a NB, a review of the technical documentation is mandatory and Article 10 requires “technical documentation shall be such as to allow the conformity of the device with the requirements of this regulation to be assessed”

On the other hand, Article 52 of the MDR gives details on the conformity assessment procedures, which are further set out in Annexes IX–XI, depending on the device risk classification. The sampling rate for the technical documentation assessment will be dependent on the risk classification, of your device.

A gap analysis against the requirements of Annex II and II of the MDR could be a good starting point for the planning of transition.

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