Eight Mistakes in Essential Requirements Checklists

Eight Mistakes in Essential Requirements Checklists

The Essential Requirements Checklist is an important and crucial tool for manufacturers in the Medical Device Industry to show compliance with the essential requirements of the European Medical Devices Directives (93/42/EC, 90/385/EEC and 98/79/EC) as outlined in Annex I of all the directives.

Auditors and assessors from notified bodies or competent authorities need to review your product against every applicable requirement. A good way of showing compliance is the so-called Essential Requirements Checklist (ERCL).

Eight mistakes you can do with your Essential Requirements Checklist:

  1. No ERCL at all. Even there is no requirement to compile such a list, it worth having one. It gives you and your assessor a quick overview over the compliance of your product. Regulators and auditors believe, that without such a list it is impossible to comply with all essential requirements.
  2. The Essential Requirements Checklist is not a controlled document. Most manufacturers of medical devices have installed a Quality Management System according to EN ISO 13485. A requirement of EN ISO 13485 is that quality documents must be controlled to some extent. The Essential Requirements Checklist is seen as such a document by regulators and, therefore, must be controlled.
  3. Referring only to numbering system of Annex I. Citing the actual requirement in the list, keeps you from looking them up all the time. The essential requirements do not change so often. Therefore it is worth the hassle.
  4. It's only for the auditor. Unfortunately, this opinion exists. But it is only one side of the coin. The auditor or assessor would like to have a quick overview. Auditors and assessors treat technical documentation differently. They dive into the section that suits them most and work their way through the documentation. It's a strong believe, if the ERCL is up-to-date und detailed, the rest of the technical documentation will be as good. But you compile for your own as well. It will give the person who is responsible for the technical documentation a tool to find out what is done, what needs to be updated and maybe what is missing.
  5. Not citing the publication date of standards. A essential requirement is usually fulfilled by applying one or more standards, regardless if they are harmonized or not. There are not explicit rules for a ERCL. However, citing the publication date of standards that were referred to, can be considered as state-of-the-art. For example: EN ISO 10993-1:2009 is better as EN ISO 10993-1. If you decide not to use the dates, they will ask for a list of applicable standards anyway. And there you are supposed to make a reference to the respective publication date of the standard.
  6. Vage references to evidence. All the essential requirements are usually proven by test reports or equivalent. It is expected that proper references are used, like "Biocompatibility Test accord. to EN ISO 10993-5, Version 2.1, 2013-10-03."
  7. Not using the the Z-Annexes of harmonized standards. Harmonized standards under the Medical Devices Directives provide Annexes that start with Z. Those annexes contain tables which show the connection between the requirement of the standard and the respective requirement of Annex I of the directives. Applying the harmonized standards assumes compliance with essential requirements.
  8. Just saying n/a, if a requirement is not applicable. Unfortunately, it is common practice just to declare a requirement as not applicable without further comment. A short comment, why certain requirements are not applicable, is a nice tweak that will be appreciated by reviewers.

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