Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the industry need. European regulations accept European specific versions of ISO standards when assessing conformance of the product and the organization’s quality management system.
The European Commission published a list of ISO/IEC standards that are harmonized with the current medical device IVD directives in March 2020. Some of the standards listed herein have been revised/updated by the ISO technical committee since the list was published, however, the list itself was never updated to include the revision.
The question then arises for the industry trying to implement these harmonized standards; which version to follow? The harmonized version or the latest version? While it is understood that the manufacturer may prefer to use the latest version of the standard to demonstrate compliance to the highest level of requirements and minimize the risk of having to initiate a transition when the latest version becomes harmonized, the notified body, however, may question the manufacturer for not utilizing the harmonized version.
The industry standard practice is to follow the ‘state of the art’ rule, which means to adopt the latest versions of the standards that apply to your product. However, this may not always be accepted by your notified body and hence you should consult your notified body before trying to adopt and implement a specific version of the standard.
Additionally, compliance with the harmonized standard is not a European legislative requirement and is considered to be voluntary best practice. Thus, safety and efficacy assurance for your product can be achieved without claiming conformance to any standards for the EU.1
The process of creating new harmonized standards needs to be revamped by the CEN. It will be interesting to see how this process unfolds for the new EU MDR and IVDR in the coming months. EMMA International can assist you in your transition to the EU MDR! Call us today at +1 248-987-4497 or email us at firstname.lastname@example.org
1European Commission- Harmonised Standards retrieved on 02/07/2021 from https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards_en