Developments in the standardization request for harmonized standards

European request for standards to support the regulations of medical devices rejected by the European Standards Organizations 

The medical devices Directives  (Medical Devices Directives (MDD), Active Implantable Medical Devices Directive (AIMDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC) have specific roles for harmonized European standards in demonstrating conformity. The European Regulations  for medical devices (MDR), 2017/745, and in vitro diagnostic medical devices (IVDR), 2017/746, also have these specific roles for harmonized European standards. Article 8 in each Regulation indicates that harmonized standards are those referenced in the Official Journal of the European Union. Devices in conformity with relevant harmonized standards, or applicable parts of standards, are presumed to be in conformity with the requirements of the Regulation covered by those standards. Additionally, the presumption of conformity also applies to system or process requirements, including those requirements relating to quality management systems and risk management.

European standards that are intended to be harmonized include a European Foreword and Annex Zs that describe the relationship between the requirements of the standard and the regulatory requirements in the European Directives or Regulations that are applicable to the scope of that standard.  

The harmonized standards listed under the Directives cannot be used to provide a presumption of conformity with the requirements of the MDR or IVDR. A Standardization Request from the European Commission to the European Standards Organizations, CEN and CENELEC, provides the legal basis to start publishing references to harmonized standards that provide a presumption of conformity under the MDR and IVDR. A Standardization Request to support the MDR was prepared by the European Commission but was not accepted by CEN and CENELEC in June 2020.

There were several issues with the Standardization Request that led to this rejection. In particular requirements in the Standardization Request that:

• the scope of harmonized European standards should be restricted only to legal requirements of the MDR and IVDR;
• definitions in harmonized European standards should not differ from those in the European legislation.

The majority of standardization work in the field of medical devices is driven internationally and most European standards in this field are adoptions of International standards. Internationally, the precise scope of regulatory requirements for medical devices differ from nation to nation and region to region, as can the definitions used in different jurisdictions.  International standards generally finesse these differences in specifying the scope of the standard and adopting definitions that encompass these regulatory differences. Some European standards committees had been successful in introducing wording into the European Foreword to indicate that, for the purposes of supporting European regulatory requirements, the standard provided a presumption of conformity only to the extent of the scope and definitions of the European regulations for medical devices. Despite this apparent flexibility, CEN and CENELEC were concerned that the wording of the Standardization Request could disrupt the alignment of European and International standards and reduce the benefits of widely accepted global standards in removing barriers to trade.

The European Commission and the European Standards Bodies are in discussion on the next steps. The Commission have asked CEN and CENELEC for a proposal. Although there is a desire to find a solution as soon as possible, it is unlikely that there would be a new Standards Request until 2021 at the earliest.

Given the current situation, it seems unlikely that there will be any harmonized European standards to support the MDR before its date of application on 26 May 2021. Nonetheless, manufacturers have a responsibility under the MDR and IVDR to make sure that their devices reflect the state of the art. It has been indicated by the Commission that the most recent editions of standards should be considered as reflecting state-of-the-art, even if earlier versions of that standard remain listed in the Official Journal. Manufacturers should engage with their notified bodies because not all notified bodies are following this approach. Manufacturers need to understand the differences between editions of the standards that they use to support compliance with regulatory requirements and be able to justify the choice of the edition of the standard to which they demonstrate conformity.

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