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

MDR Quick Guide - FAQs

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


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


  1. EU In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746
  2. European Commission Factsheet for Manufacturers of Medical Devices
  3. Update on Notified Body Designated Under MDR/IVDR
  4. MEDDEV 2.7/1 Rev. 4. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies. June 2016
  5. MDCG 2020-13: Clinical evaluation assessment report template en.pdf
  6. MDCG 2019-9: Summary of safety and clinical performance. A guide for manufacturers and notified bodies
  7. MDCG 2020-7: Post-market clinical follow-up plan template. A guide for manufacturers and notified bodies plan_template_en.pdf
  8. MDCG 2020-8: Post-market clinical follow-up evaluation report template. A guide for manufacturers and notified bodies evaluation_report_en.pdf
  9. MDCG 2020-6 Regulation 2017/745: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies
  10. MEDDEV 2.12-1 Rev. B. Guidelines on a Medical Devices Vigilance System