Preparing for Europe’s New In Vitro Diagnostic Medical Device Regulation

The Essential Guide to EU IVDR Compliance

Section 7: Appendix – FAQ, IVDR Quick Guide, and References

Frequently Asked Questions

Does the EU IVDR supersede all other EU in vitro diagnostics medical device regulations?

Yes, the IVDR supersedes the In Vitro Diagnostic Medical Device Directive (IVDD).

Are any legacy devices grandfathered under the IVDR?

No. Manufacturers with grandfathered devices under previous regulations no longer maintain their grandfather status under the IVDR.

What happens to In Vitro Diagnostic Medical Device Directive (IVDD)-certified medical devices that are lawfully placed on the market prior to, or after May 26, 2022?

Manufacturers can continue to distribute medical devices certified under the IVDD; however, the following will apply:

Devices cannot undergo significant design changes, including changes to labeling/ packaging, changes to the manufacturing process, or the addition of new features or functionality
Manufacturers must develop and implement a quality management system (QMS) and procedures for risk management, performance evaluation, and post-market surveillance (PMS)/post-market performance follow-up (PMPF) that are in line with the new regulation
IVDR registration requirements for all economic operators must be completed
Agreements between the manufacturer, authorized representative, importer, and distributor must be in place

IVDR Quick Guide

Below are key sections of IVDR 2017/746 that will most likely impact your quality management processes and documentation. Familiarize yourself with these sections to determine how your business will be impacted.

IVDR Section	Topic
Chapter II	Making available on the market, and putting into service of devices, obligations of economic operators, CE marking, free movement
Article 10	General obligations of manufacturers
Article 11	Authorized representative
Article 12	Change of authorized representative
Article 13	General obligations of importers
Article 14	General obligations of distributors
Article 15	Person responsible for regulatory compliance
Article 17	EU declaration of conformity
Chapter III	Identification and traceability of devices, registration of devices and economic operators, summary of safety and clinical performance, European database on medical devices
Article 24	Unique device identification system
Article 26	Registration of devices
Article 27	Electronic system for registration of economic operators
Article 28	Registration of manufacturers, authorized representatives, and importers
Article 30	European database for medical devices
Chapter IV	Notified bodies
Chapter V	Classification and conformity assessment
Article 47	Classification of devices
Article 48	Conformity assessment procedure
Article 49	Involvement of notified bodies in conformity assessment procedures
Chapter VI	Clinical evidence, performance evaluation, and performance studies
Article 56	Performance evaluation and clinical evidence
Article 57	General requirements regarding performance studies
Chapter VII	Post-market surveillance, vigilance, and market surveillance
Article 78	Post-market surveillance system of the manufacturer
Article 79	Post-market surveillance plan
Article 80	Post-market surveillance report
Article 81	Periodic safety update report
Article 82	Reporting of serious incidents and field corrective actions
Article 83	Trend reporting
Article 84	Analysis of serious incidents and field corrective actions
Article 87	Electronic system on vigilance and on post-market surveillance
Chapter VIII	Cooperation between member states, medical device coordination group, EU reference laboratories, and device registers
Annex I	General safety and performance requirements
Annex II	Technical documentation
Annex III	Technical documentation on post-market surveillance
Annex IV	EC declaration of conformity
Annex V	CE marking of conformity
Annex VI	Information to be submitted upon the registration of devices and economic operators in accordance with articles 26(3) and 28, core data elements to be included in the UDI database together with UDI-DI in accordance with articles 25 and 26 of the UDI system
Annex VII	Requirements to be met by notified bodies
Annex VIII	Classification rules
Annex IX	Conformity assessment, based on a quality management system and on assessment of technical documentation
Annex X	Conformity assessment based on type examination
Annex XI	Conformity assessment based on production quality assurance
Annex XII	Certificates issued by a notified body
Annex XIII	Performance evaluation, performance studies, and post-market performance follow-up
Annex XIV	Interventional clinical studies and certain other performance studies