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 Council of the European Union this week released two corrigenda.
Although the documents do not alter the transition deadlines for companies (some had hoped
there might be a break for struggling class I device companies), the corrigenda do offer a look into areas of the regulations where there may have been confusion or where slight tweaks were necessary.
On the MDR side, 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.
In Annex IX, which concerns conformity assessments based on a quality management system, the corrigendum corrects the text from “Surveillance assessment applicable to class IIa, class IIb and class III devices” to just “Surveillance assessment.”
Another correction broadens what device accessories will be classified, changing a line in Annex VII, Section 3.2 that reads: "… Accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right …", to: "… Accessories for a medical device shall be classified in their own right … ".
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.
For instance, in the first correction, 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.”
Another correction, number 16, to Annex IX broadens what devices will need technical documentation assessments.
The original line: "In the case of class C devices, the surveillance assessment shall also include an assessment of the technical documentation as referred to in Sections 4.4 to 4.8 of for the device or devices concerned on the basis of further representative …" now reads: “In the case of class B and
C devices, the surveillance assessment shall also include an assessment of the technical documentation as specified in Section 4
for the device or devices concerned on the basis of further representative …"