Jun 16, 2020

On May 15th, 2020, the European Commission published their Implementing Decision M/565 on harmonization of standards under the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR). Overseeing harmonization of standards falls to the European Commission.

In 2014, the European Court of Justice ruled that harmonized standard should be understood as the law, which in a way would make the European Commission into a lawmaker. This goes against the normal structures of legislating in the EU, so it was necessary to make significant changes in how harmonized standards are developed. Implementing decision M/565 reflects these concerns by being technology-neutral and performance-based.

Changes to the EU list of harmonized standards

When comparing the current harmonized standards with the new list for the MDR and IVDR, it immediately becomes clear much has changed:

  • The total number of standards harmonized under the Medical Devices Directive 93/42/EC (MDD) is 264, while the total number of standards for the MDR is 63;
  • Standards relating to products are not to be harmonized under the MDR or IVDR;
  • Most standards relating to processes are harmonized under the MDR/IVDR.

The harmonized standards appear to be focusing on how rather than what to do. For example, the standard for steam sterilizers (EN 285) will not be harmonized under the MDR, but the standard for devices that are terminally sterilized (EN 556-1) will remain a harmonized standard. Likewise the number of harmonized standards for IVDs will also decrease, with only 41 remaining.

New standards needed for medical devices, IVDs

For medical devices, six additional standards need to be developed and then harmonized; for IVDs, four standards need to be developed. Interestingly, the European Commission wants several specific aspects to be addressed in a few standards:

  • EN ISO 10993-7:2008; the method of calculating residue limits should also take into account body weights substantially below 70 kg;
  • EN ISO 10993-17:2009; biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances; body weights lower than 3.5 kg (neonates) must be taken into account;
  • ISO 23908; Sharps injury protection – Requirements and test methods – Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling; MDR Annex I, sections 11.1 (reduction of risk of infection to patients and users) and 22.2 (devices for lay use) must be addressed by the harmonized version of ISO 23908.

 

Learn more about European MDR compliance and timelines

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

Author

  • Ronald Boumans

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