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IVDR Corrigendum – Changes & Impact

IVDR Corrigendum – Changes & Impact

On March 13, 2019, the Council of the European Union published two draft corrigenda to fix the errors, inconsistencies, and rectify grammatical errors in EU’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The regulations were effective from May 2017.

The IVDR corrigendum lists 17 corrections that will have some impact on the way Class B devices are assessed and also suggests minor changes which are analyzed in detail below. Check the analysis to see if the changes have an impact on your device(s):

EU Publishes First Corrigenda for IVDR – Changes and Impact
S.No Section Original IVDR Regulation IVDR Corrigendum Changes Made Impact Analysis
1 Page 183, Recital (66) “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, so as to make it easier for the results of performance studies…” “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…” Standard ISO 14155:2011 is changed to ISO 20916.
IVD device specific/ relevant standard is listed, to perform clinical performance studies.
The standard ISO 20916 is under development. Manufacturers have to wait to check their compliance or design their performance studies until the standard is released.
2 Page 198, Article 10 (14) “Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 27(1). “Where manufacturers have their devices designed or manufactured by another legal or natural person the information on the identity of that person shall be part of the information to be submitted in accordance with Article 26 (3).” Reference to Article 27(1) is changed to Article 26(3). Appropriate article and clause is referred. No impact, since Article 26 (3), which is referring to Section 2 of Annex VI, is applicable to all devices. The change is made to refer the relevant article.
3 Page 207, Article 28 (1) “…in Article 30 the information…” “…in Article 27 the information…” Reference to Article 30 is changed to Article 27 No impact, since Article 27 is applicable to all devices.
The change is made to refer the relevant article.
4 Page 220, Article 48 (7), first sub-paragraph “…of Annex IX, including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex of at least one…” “…of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one…” For Class C Devices, assessment of technical documentation has to be performed as per section 4.0. The scope of entire section is included, whereas previously the scope was restricted to 4.4 to 4.8. This is a Significant Change, as sections 4.1 to 4.2 describes the procedure of applying to notified body for assessment of technical file and requirements for it. Section 4.3, and 4.8 to 4.10 describe requirements for notified body to handle the application and report. Section 4.11 lists requirements to handle changes to approved devices. Section 4.12 lists requirements for Class D devices and finally Section 4.13 lists requirements for manufacturer regarding timeframe to place the device in market.
5 Page 221, Article 48 (9), first sub-paragraph “…of Annex IX, and including an assessment of the technical documentation as specified in Sections 4.4 to 4.8 of that Annex for at least one representative…” “…of Annex IX, and, in addition, to an assessment of the technical documentation as specified in Section 4 of that Annex for at least one representative…” For Class B Devices, assessment of technical documentation has to be performed as per section 4.0. The scope of entire section is included, whereas previously the scope was restricted to 4.4 to 4.8. This is a Significant Change, as the sections 4.1 to 4.2 describe the procedure of applying to notified body for assessment of technical file and requirements for it. Section 4.3, and 4.8 to 4.10 describe requirements for notified body to handle the application and report. Section 4.11 lists requirements to handle changes to approved devices. Section 4.12 lists requirements for Class D devices and finally Section 4.13 lists requirements for manufacturer regarding timeframe to place the device in market.
6 Page 234, Article 70 (1) “…of Article 58(5), and Articles 71, 72 and 73 Article 76(5) and the relevant provisions…” “…of Article 58(5), Articles 71, 72 and 73, and Article 76(5) and (6), and the relevant provisions…” Reference to Article 76 (6) included. No impact, as is not a significant change. Included additional reference to give more clarity. However, intent of the clause and article remains unchanged.
7 Page 238, Article 74 (14) The procedure set out in this Article shall, until 27 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. After 27 May 2029, all Member States shall be required to apply that procedure.” The procedure set out in this Article shall, until 25 May 2029, be applied only by those of the Member States in which the performance studies are to be conducted which have agreed to apply it. From 26 May 2029, all Member States shall be required to apply that procedure.” Date to apply the coordinated assessment procedure for performance studies is changed from “After 27 May 2029” to “From 26 May 2029” No impact as is not a significant change. The application date is changed to a day earlier to align with other application date and to give more clarity. The intent of the clause and article remains same.
8 Page 256, Article 110 (4) Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.” Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022 and devices placed on the market from 26 May 2022 by virtue of a certificate as referred to in paragraph 2 of this Article, may continue to be made available on the market or put into service until 27 May 2025.” No significant change. Edited for clarity. No impact. The clause is edited to give clarity. Intent of the clause remains the same.
9 Page 258, point (g) of Article 113(3) The procedure set out in Article 74 shall, apply from 26 May 2027 without prejudice to Article 74(14).” the procedure set out in Article 74 shall apply from 26 May 2029 without prejudice to Article 74(14);” Date of application of Article 74 changed from May 26, 2027, to May 26, 2029 No impact. The date has been changed in alignment with Article 74 (14) to correct the typo error.
10 Page 296, Annex VII, Section 4.5.2, Point (a), fourth indent “That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate,” “That plan shall ensure that the entire range of devices covered by the certificate is sampled over the period of validity of the certificate, and, The term “all devices” is changed to “entire range of devices” Significant Change. Sampling of “all devices” over a period of five years may not be required anymore. The notified body sampling plan shall cover the entire range of devices covered by that certificate but not every single device.
It is similar to the existing process of IVDD Certification where sampling is done based on the risks associated with the intended use of the device, the complexity of the manufacturing technologies, the range and classes of devices produced and any available post-market surveillance information.
11 Page 306, Annex IX, Section 2.1, sixth indent “…procedures in place to fulfil the obligations arising from by the quality management system…” “…procedures in place to fulfil the obligations arising from the quality management system…” Edited the grammatical error. No impact. Edited to correct the grammatical error.
12 Page 308, Annex IX, Section 2.3, first sub-paragraph “…unless it duly substantiate not doing so.” “…unless it duly substantiates not doing so.” Edited the grammatical error. No impact. Edited to correct the grammatical error.
13 Page 308, Annex IX, Section 2.3, third sub-paragraph “Moreover, in the case of class C devices, the quality management system assessment shall be accompanied by the assessment of the technical documentation for devices selected on a representative basis in accordance with provisions in Sections 4.4 to 4.8. In choosing…” “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. In choosing…” Inclusion of Class B for QMS assessment per Annex IX and inclusion of Section 4 for technical documentation assessment to align with the changes made in #4 and #5. No impact. Edited to align with “Article 48 (9), Page 221, first sub-paragraph” and to align with the changes made in #5.
14 Page 308, Annex IX, Section 2.3, fourth sub-paragraph, second sentence “The notified body shall notify the manufacturer of tits decision to issue the certificate.” “The notified body shall notify the manufacturer of its decision to issue the certificate.” Edited the typo error. No impact. Edited to correct the grammatical error.
15 Page 308, Annex IX, Section 3 Surveillance assessment applicable to class C and class D devices Surveillance assessment” The term “applicable to class C and class D device” is removed This is a Significant Change. Surveillance assessment is now applicable to Class B devices too.
16 Page 309, Annex IX, Section 3.5 “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…” “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…” Inclusion of Class B for surveillance assessment to align with changes made in #15 and inclusion of Section 4 for technical documentation assessment to align with the changes made in #4 and #5. This is a significant change. Surveillance assessment is now applicable to Class B devices and technical documentation assessment is as per Section 4.
17 Page 310, Annex IX, Section 4.3 “The notified body shall examine the application by using staff, employed by it, with proven knowledge…” “The notified body shall assess the technical documentation using staff with proven knowledge…” The word “employed by it” is removed. This gives flexibility to Notified Body, to use third party technical consultants/ subject matter experts for technical documentation review without employing them.
Summary
1. Rules on performance studies should be in line with well-established international guidance in this field, such as “ISO 20916 on clinical performance studies using specimens from human subjects, currently under development.”
2. The technical documentation assessment of Class B and Class C is broadened to include all the requirements in Section 4 of Annex IX. Surveillance assessment scope is broadened to include Class B devices.
3. Sampling of “all devices” over a period of five years may not be required anymore. The notified body sampling plan shall cover the entire range of devices covered by that certificate but not every single device.
4. Notified body can use third party technical consultants/ subject matter experts for technical documentation assessment without employing them.

DISCLAIMER – This article contains a summarised information of a regulation and is for general understanding only. For more detailed analysis or making professional judgements readers are directed towards IVDR regulations (EU) 2017/746 of the European parliament or contact us


By Mohammed Adil | May 20th, 2019

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