Since the establishment of the Vienna Agreement in the early 1990s, ISO and CEN have worked together to successfully create a body of standards that promote the safety and effectiveness of medical devices worldwide. These standards are adopted and utilized by regulatory authorities across the globe. ISO/TC 210 has been a key leader in these efforts toward global standardization.
In recent years, progress toward harmonization has been hindered for documents intended to support the European Medical Device Regulations for several reasons, leading to substantive delays in advancing documents and in gaining recognition of those documents by the EU.
Currently, the following standards from ISO/TC 210, developed under the Vienna Agreement with CEN-CLC JTC3, are impacted by CEN HAS assessments.
- ISO 13485:2016, Medical devices — Quality management systems -- Requirements for regulatory purposes, 3rd ed.
This document was decoupled from the Regulations and was published by ISO and CEN. The EN version is recognized by the EU Commission for the Directives. An amendment providing new Annex Z’s that harmonize the standard with the new EU Medical Device Regulations is currently undergoing Formal Approval ballot in CEN (Amendment A1:2021). The voting deadline is 2021-03-11.
No action is required on the part of ISO/TC 210. Current issues affect only recognition by the EU.
- ISO 14971:2019, Medical devices — Application of risk management to medical devices, 3rd ed.
This document was decoupled from the Regulations and was published by ISO and by CEN. A recent assessment by the HAS consultant found a ‘lack of compliance’ and demanded that the standard be redrafted. CEN-CLC/JTC 3 leadership is challenging this assessment.
No action is required on the part of ISO/TC 210. Current issues affect only recognition by the EU.
- ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements, 3rd ed.
This document was decoupled from the Regulations and was published by ISO and CEN. The EN version is recognized by the EU Commission for the Directives. An amendment providing new Annex Z’s that harmonize the standard with the new EU Medical Device Regulations is currently undergoing Formal Approval ballot in CEN (Amendment A1:2021). The voting deadline is 2021-02-18.
No action is required on the part of ISO/TC 210. Current issues affect only recognition by the EU.
- ISO/FDIS 15223-1:202X Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements, 4th ed.
ISO 15223-1 completed parallel ISO and CEN Enquiry ballots in May 2020. The document was approved unanimously in both CEN and ISO. A circulation date was set for early January 2021.
Before the Final Approval ballots were initiated, the document was placed under a pilot program where the CEN HAS consultant would assess the draft in advance. This would allow any potential assessment objections to be resolved prior to the ballot. This delayed the January 2021 initiation of the Final Approval Ballots.
A negative CEN HAS assessment was subsequently received in early February indicating a ‘lack of compliance’ and asking for a limited number of minor changes only in the European Foreword/Annexes. ISO TC ISO/TC 210 has worked with CEN-CLC/JTC 3 to resolve the situation and the parallel Final Approval ballots are expected to begin soon.
If, the document does not advance for parallel ISO and CEN Final Approval ballots within a short period, ISO/TC 210 will initiate a separate FDIS ballot, removing the document from the Vienna Agreement.
- ISO 20417, Medical devices — Information to be supplied by the manufacturer.
ISO 20417 underwent parallel ISO/CEN Enquiry ballots in 2019. A negative CEN HAS assessment was filed at the Enquiry stages. A revised document was advanced for parallel FDIS/Final Approval ballots in early 2020 and a CEN HAS assessment was requested. The document was approved by both ISO and CEN, but apparently no assessment was filed at that stage.
A negative assessment on the draft for final publication, however, was received in early January 2021. The effect of this negative assessment has been to halt the publication of the standard. As the document has already gone through Final Approval ballots and achieved consensus in CEN and ISO, the objections raised in this final assessment cannot be resolved.
CEN-CLC/JTC 3 has requested that CEN-CLC/BT decouple the standard from the EU Medical Device Regulations. Failing this decoupling, ISO/TC 210 will move forward to publication, removing the document from the Vienna Agreement.
Other ISO/TC 210 documents are currently listed under the Vienna Agreement, but have not yet reached Enquiry stage and have not yet been assessed by the CEN HAS consultant.
While there are paths forward to overcome current roadblocks to ISO 15223-1 and ISO 20417, it is not certain the problems with the implementation of the Vienna Agreement and corollary CEN HAS consultant processes will be fixed in the near future. The new EC Standardization Request may not be accepted by CEN/CLC or the revision/drafting demands may not be acceptable to the other members of ISO/TC 210. There is also no guarantee that the inconsistency in CEN HAS assessment criteria over the past several years will be resolved. Unless there are major changes in the implementation of the Vienna Agreement and CEN HAS consultant processes, substantial delays in ISO/TC 210 standards development are likely to continue to occur.
ISO/TC 210 will monitor the situation and be prepared to remove any unduly hindered work items from Vienna Agreement processing. It is premature to consider the more drastic solutions that other ISO technical committees are pursuing (e.g., decoupling all work items from the regulations or ceasing to utilize the Vienna Agreement entirely).