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.