Further harmonization of standards
Commission Implementing Decision (EU) 2022/6 of January 4, 2022, amending Implementing Decision (EU) 2021/1182 in relation to harmonized standards for medical devices in support of the MDR has currently been published in the Official Journal of the European Union.
Most medical device manufacturers use harmonized standards to demonstrate the conformity of their medical devices with the essential requirements. The harmonization process had not continued in the interim, but was resumed in July last year with initial harmonizations. These Implementing Decisions concerned almost exclusively the sterilization of devices and biocompatibility (cf. Implementing Decision on standards harmonized under the MDR and the Implementing Decision on standards harmonized under the IVDR).
Now, additional standards have been harmonized. These are ISO standards on testing and sterilization.
Why are harmonized standards relevant to medical device manufacturers and what follows from a lack of harmonization?
Without harmonized standards, neither manufacturers nor authorities and notified bodies have sufficiently clear guidance, and there is a risk of disputing the applicable state of the art in each case, which in turn can lead to difficulties in audits and approvals. MDR and IVDR, despite the uncertainty of the meaning of the term in the context of the regulations in the absence of a definition, use diverse requirements: the “state of the art,” the “newest state of the art,” the “generally accepted state of the art,” and the “current state of the art.”
Article 8 of the MDR incorporates the concept of harmonized standards with respect to documentary evidence.
“Devices which are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements of this Regulation covered by those standards or parts thereof.”
For more information related to the Medical Devices Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC), see our previous posts.