On March 13th, 2019 the Council of the European Union released two corrigenda documents, pertaining to the Regulation (EU) 2017/745 on Medical Devices and the (EU) 2017/746 on In Vitro Diagnostics Medical Devices. In an effort to rectify mistakes and discrepancies within the new European Regulatory framework, Member States were allowed to send comments and suggestions up until March 20th of this year. Then, on May 5th,2019 the official documents for the (EU) MDR 2017/745 and IVDR 2017/746 corrigenda were released by the Official Journal of the European Union.
The MDR corrigendum has 14 corrections listed. The most important corrections noted are:
- Annex IX, Section 2.3, third paragraph, with the inclusion in the first sentence of “by the assessment of technical documentation of devices selected on a representative basis as specified in Section 4,” instead of “basis in accordance with Sections 4.4 to 4.8.”
- Annex VII, Section 4.5.2, Point (a), fourth indent , with the following change “that the entire range of devices covered by the certificate is sampled over ” replacing "...That plan shall ensure that all devices covered by the certificate are sampled over ...",
- Finally, Annex IX, Section4.3, first paragraph, it is now “the notified body shall assess the technical documentation using staff with proven knowledge ...” with deletion of “employed by it.”
- Some other note worthy changes also include: Annex VIII which was rectified to state “accessories for a medical device shall be classified in their own right,” – rather than, “accessories for a medical device and for a product listed in Annex XVI shall be classified in their own right.”
The IVDR corrigendum unlike the MDR has 17 corrections. Most of these focus on grammatical errors, while some focus on improved clarifications for specific Annexes. Some important corrections to note are:
- Annex IX, Section 2.3, third sub paragraph which states, “Moreover, in the case of class B and C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis as specified in Section 4.”
- The other change made within Annex IX, is in Section 3.5 with “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.”
- The original statements for both of these corrections initially had a focus on just class C devices and section 4.4 and 4.8. However, the corrections now include class B and C devices with a focus on all of section 4 rather than just 4.4 and 4.8.
It is also important to note the correction of Recital (66) at the beginning of the IVDR corrigendum, which reads:
“The rules on performance studies should be in line with well-established international guidance in this field, such as the international standard ISO 20916 on clinical performance studies using specimens from human subjects, currently under development, so as to make it easier for the results of performance studies.”
The initial statement referenced the ISO 14155:2011 instead of ISO 20196.