The Medical Device Regulation (MDR) of the European Union (EU) sets stringent safety and performance requirements that manufacturers must meet to place their medical devices on the market. The evidence of conformity is presented in technical documentation.
In this blog, we explore some challenges manufacturers face when preparing technical documentation based on the recommendations of The European Association of Medical Devices Notified Bodies (Team NB).
The key requirements for technical documentation under the MDR are stated in Annex II and Annex III, with Annex III specifically addressing post-market surveillance (PMS). The manufacturer’s technical documentation should be structured to comprehensively address these requirements and include or reference the Declaration of Conformity (Annex IV).
The MDR emphasizes the importance of a clear and well-structured technical documentation, as stated in the first paragraph of Annex II:
"The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable, and unambiguous manner and shall include, in particular, the elements listed in this Annex."
A well-structured technical documentation summary, with links or references to the main submission, not only streamlines the review process, it also leads to quicker approval by notified bodies. This approach facilitates efficient document management, making future updates more efficient.
Team NB’s 2023 guidance document outlines expectations for technical documentation submissions, in alignment with MDR Annexes II and III. The document highlights the most common reasons for delays in technical documentation reviews, including:
• Information – Insufficient, inconsistent or missing information necessary for complete conformity assessment activities. This includes an incomplete or inconsistent description(s) of device(s) covered in the application, as well as associated technical documentation (e.g., variants, accessories, combined devices covered by the Basic UDI-DI to be assessed).
• Lack of a Cohesive Structure – While the information is present, it is difficult to locate within the technical documentation.
• Excessive Scope – The submission scope is too broad for a single conformity assessment, extending beyond a common intended purpose, design or system of devices intended to be used together.
To improve submission quality and prevent delays, Team NB recommends the following these eight key points:
1. Language Requirements
„Manufacturers should contact their notified body to clarify the language requirements for the technical documentation submission of the individual notified body as mentioned in MDR Article 52 (12)“
While some notified bodies may accept multiple languages, submitting documents in English aligns with international standards and can facilitate the review process and reimbursement across multiple territories. For example, DQS accepts submissions in English and German for CE conformity assessment, yet only English language documents can be accepted for MDSAP and UKCA.
2. Labelling and Submission Methods
„Manufacturers should also contact their notified body to clarify the requirements related to documentation labelling and methods for submission to the notified body.“
Knowing the correct method ensures proper documentation and avoids delays. At DQS, each client is assigned a Regulatory Affairs Manager who will support them with the requirements for documentation labelling relevant to their submission.
3. Comprehensive and Up-to-Date Reports
“Where appropriate the most recently updated comprehensive reports and data should be included. Abbreviated or partial test reports are not considered acceptable.”
It would be also important to remark, if external laboratory conducted testing, for credibility and traceability manufacturers should ensure that the test reports include the accreditation details of the laboratory and the full methodologies used .
4. Complete Verification Reports
“Verification reports provided should be complete, i.e. not a report with subsequent amendments or revisions as the device was changed.”
If modifications have been made, provide explanations, justifications and links to previous versions of technical documentation for clarity.
5. Compliance with MDR Annex I GSPR (General Safety and Performance Requirements)
„The technical documentation should document how the manufacturer ensures compliance to every applicable MDR Annex I GSPR. Note that, per section, a simple collection of test/verification reports does not fulfil this requirement.“
To meet this requirement, manufacturers should include risk assessments (aligned with the latest version of ISO 14971) to justify the level of testing performed.
6. Consistency in Duplicated Information
There are many areas of the technical documentation that will require the duplication of information for multiple documents such as device description. Please ensure that the information is correct throughout all areas where this information is duplicated and consider the risk of potential errors/inconsistencies when updating (e.g. Basic UDI-DI, UDI-DI, intended use, indications for use, contraindications, warnings, etc.).
Where feasible, consider using an electronic document management systems to synchronize updates across all documentation.
7. Consistency With Application Forms
“Ensure the data in the technical documentation is consistent with the data provided in the respective application forms. “
Manufacturers should check for common inconsistencies, such as mismatched device names, incorrect UDI information, or outdated clinical data.
8. Valid Justifications for Data Deficiencies
“Valid justifications should always be provided or accompanied where there are deficiencies in the requested data. “
Any missing data should be explained with a scientifically sound justification, supported by risk assessments, clinical evidence, or literature searches. Reference applicable MDR articles or harmonized standards to substantiate the claims.
Do you have questions about obtaining CE Marking in Europe for your medical device under Regulation MDR? Reach out to us for more information and assistance.
For a detailed outline of the requirements, readers are encouraged to download the following document: Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 of Team-NB Position Paper (April 2023, Version 2)
