Corrigenda to the Regulations

The Council of the European Union released two corrigenda as part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).

The IVDR corrigendum includes 17 corrections which include some minor tweaks and grammatical corrections but also some others that may have more of an impact.
The most important corrections made are:

• 1. Amendment on page 183, recital (66): the line explaining how the “rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 14155:2011 on good clinical practice for clinical investigations of medical devices for human subjects” changes the international standard to “ISO 20916 on clinical performance studies using specimens from human subjects, currently under development.”
• 4. Amendment on page 220, Article 48 (7), first subparagraph: for class C devices the technical documentation is to be assessed as specified in section 4 of Annex IX, so no longer limited to sections 4.4 to 4.8.
• 5. Similarly, amendment on page 221, article 48(9) first subparagraph: for class B devices the technical documentation is to be assessed as specified in section 4 of Annex IX, so no longer limited to sections 4.4 to 4.8.
• 13. Amendment on page 308, Annex IX, Section 2.3, the third paragraph: class B devices have now been included and the technical documentation is to be assessed on a representative base as specified in Section 4 of the same Annex, not only Sections 4.4 to 4.8.
• 15. Amendment on page 308, Annex IX, Section 3: is now simply “Surveillance assessment”, the applicability limitation to class C and D devices alone has been removed.
• 16. Amendment on page 309 Annex IX Section 3.5: class B has been added and the technical documentation is to be assessed as specified in Section 4 of the same Annex, not only Sections 4.4 to 4.8.

The MDR corrigendum includes 14 corrections, with some as simple as changing the word “trademark” to “trade mark”, or grammatical changes.
The most important corrections made are:

• 7. Amendment on page 90 article 120 (10): the removal of the reference to Article 1 (6) (f) implies that devices manufactured utilising cells or tissues of animal origins legally placed on the market prior to 26 May 2020 are now excluded from the transition provision in article 120 (10) and thus will not be allowed to be placed on the market after the date of application in member states that previously allowed them.
• 9. Amendment on page 140 Annex VIII Section 3.2: accessories to Annex XVI non-medical devices are not classified in their own right anymore.
• 10. Amendment on page 148 Annex IX section 2.3 third paragraph, first sentence: … the assessment of technical documentation for devices selected on a representative basis as specified in Section 4 (of Annex IX). No longer limited to section 4.4 to 4.8.