The Do's and Don'ts of writing standards for harmonization

CEN/CENELEC give advice to smooth the route for medical devices standards

A previous blog has discussed the delays in formal harmonization of European standards for the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD). Despite a lot of effort to keep up with the evolving requirements for citation in the Official Journal, changing formats for Annex Zs in harmonised standards and reworking of European Forewords and Annex Zs, there was a significant delay until the latest batch of standards was cited in November 2017. The latest information shows that there is still around 10% of potential harmonised standards in the queue to be cited.

In order to try and facilitate the harmonization process, CEN/CENELC and the European Commission have recently provided training for standards drafters highlighting ways to address the issues that have prevented harmonization. The slides used in the training have been made available.

The most common reasons that standards have been rejected for citation in the Official Journal are:

• Either no Annex Z was included in the standard or the wrong format was used for the Annex Z.
• Insufficient detail provided on any limitations of coverage of the regulatory requirements as comments or notes in the Annex Z.
• Concerns over the reference documents that were cited normatively – that is reference to other standards included as requirements in the standard under consideration.

A number of issues were raised in regards to using normative references. 

• Normative reference should not be made to informative documents or informative parts of standards.
• If coverage of a regulatory requirement is only provided in the normative reference, there should not be a claim of a presumption of conformity. The standard referenced normatively should have that presumption of conformity itself for that regulatory requirement. For example, if a standard for a sterile medical device normatively references a standard for validation of sterilization, the presumption of conformity in respect of sterility should be provided by the sterilization standard and not the medical device standard.
• Normative reference to a test method can only provide a presumption of conformity if criteria for acceptance are also provided.
• Chains of normative references, where one standard references another which, in turn, references further standards normatively, should be avoided.

In writing standards, it is common to cite an undated normative reference so that the latest version of the referenced standard applies. However, this presents a problem for the presumption of conformance as it is not known if a future edition of the standard will provide coverage of the regulatory requirement. Consequently, in European adoptions of international standards, the European Foreword provides dates for any undated normative references. These dated references apply in the European adoption of the standard.

It is important for standards writers to provide clear and precise references that compliment the standard that they are writing. The standard that is referenced must itself be in the scope of the standardization request agreed with the European Commission more quickly. The guidance provided in the training gives some much-needed clarity to the expectations for harmonization and should help smooth the route for future standards to be recognized more quickly.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development.