The eagerly-awaited corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) have now been released by the European Commission.
To many in the industry, the revisions to the regulations will be disappointing, as they correct only typographic or other obvious errors in the original documents, without addressing any of the dozens of ambiguous requirements, which are already leading to different interpretations by manufacturers, notified bodies and competent authorities.
This result is despite the fact that the French competent authority ANSM published a report from a meeting with industry in which it went on the record saying that In addition to simple editorial corrections, it had been proposed to extend the transitional measures to Class I devices that newly require the use of a notified body or Class I devices that change class under the MDR, in order to avoid overloading NBs.
In the MDR corrigendum, there are 14 corrections, with some as simple as changing the word “trademark” to “trade mark” in Articles 2 and 7, or grammatical changes, while others, such as correction number 7, will mean that products of animal origins legally placed on the market prior to 26 May 2020 will not be allowed on the market after that transition date in such member states that previously allowed them.
The IVDR corrigendum, meanwhile, includes 17 corrections, with some minor tweaks that match the MDR changes, corrections of grammatical errors and others that may have more of an impact.