#32026D1231Updated EU Harmonised Standards for Medical Devices
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Updates the EU list of harmonised standards that medical device manufacturers can use to show compliance with EU medical device rules. The changes cover technical standards for biological evaluation, manufacturer information symbols, medical electrical equipment, transfusion equipment, ophthalmic optics, surgical implants, washer-disinfectors, prosthetics, and sharps injury protection. Manufacturers, notified bodies, and compliance teams should check whether their conformity files, labels, symbols, test reports, and technical documentation rely on the affected standards. Products may need documentation updates where the amended standards replace or modify earlier references.
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Key Changes
- Adds updated references for amended harmonised standards used under the EU Medical Device Regulation
- Covers revised standards for biological evaluation, medical device symbols, and medical electrical equipment
- Extends the update to several device and equipment areas, including transfusion equipment, ophthalmic optics, surgical implants, washer-disinfectors, prosthetics, and sharps injury protection
Obligations
What this law requires
Medical device manufacturers that rely on harmonised standards to claim presumption of conformity under Regulation (EU) 2017/745 should verify whether their technical documentation, test reports, labelling symbols, and conformity files reference the amended standards listed by Implementing Decision (EU) 2026/1231.
Manufacturers should update conformity documentation where affected earlier harmonised standard references have been replaced or amended for biological evaluation of medical devices, manufacturer-supplied information symbols, medical electrical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prosthetics, or sharps injury protection.
Notified bodies assessing medical devices should check whether conformity assessments rely on standards amended by Implementing Decision (EU) 2026/1231 and assess the impact on evidence used to demonstrate compliance with Regulation (EU) 2017/745.