On 16 April 2021, the Medical Device Coordination Group (MDCG) published “Guidance on Standardisation for Medical Devices” (MDCG 2021-5). This document aims to provide guidance on varying aspects for medical device standards for both the existing directives (MDD, AIMD, IVD) and the new EU regulations, MDR and IVDR.
The guidance is split into four sections with section one providing a generic background to the use of harmonized standards and the concept of presumption to conformity. It also includes the process of documenting the harmonized standards in the Official Journal [OJ] of the European Union.
The second section explains the general framework for harmonised standards in the principles of the “New Approach” and the “New Legislative Framework,” implemented through Regulation (EU) No 1025/2012 on European standardisation. This section also makes the point that adherence to standards, whether harmonised or not, is a voluntary process under the discretion of the manufacturer and cannot be mandated by either Notified Bodies or Competent Authorities (even the use of technical solutions developed by the manufacturer are acceptable). Important Note: The guidance does highlight an important exception to this voluntary principle in relation to symbols and identification colours where both the directives and the new regulations for medical devices require conformance with the harmonised standard.
The second section also explains the process of Annex Z in the harmonised standards, and how they clearly identify the contents of the standard that are appropriate to cover, or partially cover, the Essential Requirements (ERs) defined in MDD Annex I, and to confer the presumption of conformity with them. It should be noted that presently, there are no harmonised standards to the MDR, hence no presence of Annex Z’s relating to the MDR. This remains a fundamental concern for the practical application of standards under the MDR and IVDR.
Section three addresses the concept of State of the Art (SOTA) and how this concept relates to harmonized standards. Highlighted is the very topical issue for many manufactures: the potential conflict between the use of the latest version of a standard and use of the harmonised version of that standard. While the latest version may represent the state of the art, if the standard is not harmonized, it does not automatically imply compliance with the requirements of the medical device legislation. The new MDCG guidance does not resolve this issue, but does reiterate that the use of standards remains voluntary for manufacturers and that compliance must be assessed against legal requirements rather than a particular standard. A useful collation of European and International definitions for state of the art is also provided in this section.
The third section also gives further background on harmonised standards in the EU system and the role of the European Committee for Standardisation (CEN), for most types of medical devices, and the European Committee for Electrotechnical Standardisation (Cenelec) for medical electrical devices.
The fourth and final section covers the governance structure for medical device standards and the role of MDCG, and more specifically, the work of the MDCG Subgroup on Standards (Working Group 2). There is also information on the CEN-Cenelec Advisory Board on Healthcare Standards (ABHS).
Overall, the MDCG guidance is a useful document in explaining the history, background and processes of standard harmonisation in the European system from both a generic and medical device perspective. It raises the important standards issue: state of the art standard versus harmonised, which has become critical for both manufacturers and Notified Bodies given the complete absence of harmonisation under the MDR and IVDR, and limited updates to harmonisation under the directives. Information regarding specific timelines and priorities for the formal publication in the OJ of harmonised standards in relation to the new MDR regulation is lacking—as is practical advice for manufacturers. Unfortunately, manufacturers are left to decide which standards and versions they should apply. However, one proven strategy for success is to conduct a documented gap assessment, taking into account the latest standard and harmonized versions, as well as the relevant requirements in the legislation.
How Can NAMSA Help?
NAMSA is the industry leader in driving successful regulatory outcomes through effective interactions with the EU Commission and Notified Bodies. Our internal teams of medical device development experts communicate with EU entities nearly every day and are the most experienced in industry at accelerating regulatory submissions and approvals for device manufacturers.
Additionally, NAMSA provides support to market authorization holders, including implementation of MDR requirements, MDR/IVDR conformity strategies, gap assessments and compilation of appropriate technical documentation for submission to Notified Bodies.
Learn more about NAMSA’s MDR and IVDR resources here.
Jane Arnold-Round has 30 years’ experience in the medical device industry working with a broad range of medical device technologies and organisations from start-ups to multinationals. She was a Notified Body reviewer for over 15 years having worked for BSI as a medical device product specialist with particular responsibility for the wound care sector, device-drug combinations medical device utilising animal tissues. A regulatory consultant for 17 years, she joined the medical device consulting team at NAMSA in 2018 and currently serves as a Senior Principal Regulatory Consultant.
Kevin Butcher is an experienced Senior Manager with extensive knowledge of medical device regulatory requirements, including Product Technical Files and QMS 3rd Party auditing. Mr. Butcher possesses 18 years of Notified Body experience, latterly as Certification Manager for SGS United Kingdom. Kevin joined the medical device consulting team at NAMSA in January 2021 and currently serves as a Principal Regulatory Consultant.