It is also important that there will be no copyrights on symbols, because their use is now requested in the requirement. New symbols must be developed for IVDs and medical devices. Emergo already suggested those symbols in May 2017 in its White Paper on the MDR; these symbols do not have a copy right and may be used freely by the European Commission.
Industry is given until 27 May 2024 to comply with these standards. First, CEN/CENELEC must harmonize these standards, and then manufacturers can start complying with them. Compliance with these standards is necessary for certificates that are newly issued, as well as for certificate renewals. It is not necessary to update a certificate because of an update in the standards.
It is not clear if these requests automatically concern the most recent version of a standard. For example, the harmonization request for the ISO 14971 risk management standard pertains to ISO 14971:2012 and not ISO 14971:2019.
A manufacturer may still rely on standards, even if they are no longer harmonized. Standards represent the state of the art in technology, and therefore should be used to demonstrate this. Their use remains voluntary. Regarding issues such as innovative technologies, product use in new clinical contexts, etc., it is possible to demonstrate safety and performance in other ways.
Below are a few examples of standards identified for harmonization under the MDR and IVDR (a full list of affected standards may be referenced in the Implementing Decision M/565 document):
EN 556-1:2001 for medical device sterilization: updated to EN 556-1:2001+AC:2006 for MDR
EN ISO 10993-1:2009 for biological evaluation of medical devices: updated to EN ISO 10993-1:2018 for MDR
EN ISO 11135-1:2007 for sterilization of medical devices using ethylene oxide: updated to EN ISO 11135:2014 for MDR
EN ISO 13485:2016 for medical device quality management: updated to EN ISO 13485:2016+AC:2018 for MDR
Additional European MDR and IVDR compliance resources from Emergo by UL:
EU MDR preparation and resource center
European CE Marking support for IVD device manufacturers
Whitepaper: Medical device labels, standards and symbols
Whitepaper: Understanding Europe’s IVDR