MDR Technical documentation requirements will be one of the main challenges for the medical device manufacturers during transition from 93/42/EEC (MDD) to EU 2017/745 (MDR). As explained on “How to CE Mark your medical device” article, preparation of the technical file is a critical milestone. Since there is no grandfathering for the devices on the market, medical devices requiring a CE certificate will need an initial certification audit by a notified body (NB). Although the transitional period can be used for current MDD certificates for Class III, Class IIb and Class IIa until 2024 and for Class I medical devices until 2021, the European Commission submitted a proposal on 6 January 2023, which was negotiated by the European Parliament and the Council in an urgency procedure regarding the extension of the legacy medical devices not yet certified under the MDR to remain on the European market for set periods of time. Following this adoption by the Council, the proposed amendment to the Medical Devices Regulation has been formally adopted by both the European Parliament and the Council on 15 March 2023.On 20 March 2023 it has been published in the Official Journal and entered into force. According to this amendment, the deadline is for Class III and Class IIb implantable 31 December 2027 and for Class IIb, Class IIa and Class I 31 December 2028, for Class III custom-made implantable 26 May 2026 medical device manufacturers and companies planning to put new medical devices on the market. In each case an early planning and revision of the technical documentation would bring many advantages.
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/2.5.1 Rec5). MDR now provides, in Annex II detailed requirements for the minimum content of technical documentation, together with a specific structure. Therefore, medical device manufacturers shall use this annex to ensure compliance with the new regulation.
The requirements for technical documentation are mainly given in Annexes II and III of the MDR. As summarized below Annex II lists the technical documentation chapters and Annex III includes requirements for technical documentation on Post Market Surveillance (PMS).
MDR Technical Documentation Content
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
For detailed requirements for technical documentation on Post Market Surveillance (Annex III), you can read our PMS article.
MDR Technical Documentation Format
In all conformity assessment procedures involving a NB, a review of the technical documentation is mandatory. Standalone Class I devices which do not require NB certificate are subject to random competent authority inspections. Therefore, as defined on Article 10 the technical documentation shall be prepared in an auditable format. 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.
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 format, which consist of chapters covering Annex II requirements (in the same order) would be an easy choice. You can start with a gap analysis against the requirements of Annex II and detail your structure according to the findings. Feel free to contact us for a sample template which would be suitable to your device type and risk classification. Our experts will be more than happy to assist you.