Considerations on inclusion of standards in your technical documentation (acc. to MDR, Annex II) / your documentation for the notified body opinion (acc. to MDR, Article 117) – the importance of clarity.
Compliance with (harmonised) standards is an important element to demonstrate conformity with the general safety and performance requirements (Annex I) as defined in the Medical Device Regulation (MDR; Regulation (EU) 2017/745 on medical devices).
Conformity with the general safety and performance requirements is applicable to medical devices (as defined in Article 2(1), MDR) as well as to (medical) device parts of (single) integral products (as defined in Article 117 referring to the 2nd subparagraph of Article 1(8) and Article 1(9), MDR); see summary within the figure below.
What should you consider?
Inclusion of standards is more than providing a list of standards that you determined as applicable.
This list of applicable standards is the overview on the solutions applied – this means that you must have underlying evidence within your technical documentation that demonstrate your compliance to them.
The necessity of providing this documented objective evidence is part of the overall demonstration of conformity with the general safety and performance requirements (see Annex II, section 4, MDR as well as TEAM NB Position Paper on Documentation Requirements for Drug Device Combination Products ).
Why is clarity important?
Be clear and precise on the applicable standards –especially on clearly stating the full or partial applicability of the respective standard. When state the full standard being applicable, you must have “full” documented objective evidence; when you state partial applicability, the partiality must be justified (giving a written rationale) and the parts being applicable have to be covered by respective documented evidence. The key considerations are described in the figure below.
Missing clarity and/or missing objective evidence will lead to request from the notified body and thus potential delay and/or non-conformities within your assessment. Thus, ensure proactive clarity to enable a smooth assessment with a positive outcome.
Would you like to know more about standards or compliance with Annex I? Please reach out to us!
Unique Device Identification (UDI) systems are arising worldwide, and understanding similarities and differences between them is key to be able to meet the requirements for each specific country or region.