Section 7: APPENDIX

FREQUENTLY ASKED QUESTIONS

Does the EU MDR supersede all other EU medical device regulations?

Yes, the MDR supersedes both the Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD).

Are any legacy devices grandfathered under the MDR?

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

What is the difference between a clinical investigation and clinical evaluation?

A clinical investigation is a one-time study conducted on humans to demonstrate the safety and performance of the medical device, whereas a clinical evaluation is a continuous process of generating, collecting, analyzing, and evaluating clinical data throughout the medical device’s lifecycle to demonstrate conformance with general safety and performance requirements and its intended use¹⁰.

What is considered “sufficient clinical data” for legacy devices under the new regulation?

The Medical Device Coordination Group (MDCG), an expert committee required by the MDR, has developed a guidance document, MDCG 2020-6, on sufficient clinical evidence needed for medical devices previously CE marked under the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD)¹¹.

According to the MDCG 2020-6 guidance document: Post-market clinical data as well as clinical data generated for the MDD/AIMDD conformity assessment are the basis for the clinical evaluation under the new regulation. In addition, manufacturers will need to conduct a gap assessment with the General Safety and Performance Requirements of the MDR to determine if any additional data is needed.

What happens to Medical Device Directive (MDD)- and Active Implantable Medical Device Directive (AIMDD)-certified medical devices that are lawfully placed on the market prior to, or after May 26, 2021?

Manufacturers can continue to distribute medical devices certified under the MDD or AIMDD; 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, clinical evaluation, and post-market surveillance (PMS)/post-market clinical follow-up (PMCF) that are in line with the new regulation
• MDR registration requirements for all economic operators must be completed
• Agreements between the manufacturer, authorized representative, importer, and distributor must be in place

MDR Quick Guide

Below are key sections of MDR 2017/745 that will most likely impact your quality management processes and documentation. Familiarize yourself with these sections to determine how your business will be impacted.

MDR Sections & Topics

• Article 10 – General obligations of manufacturers
• Article 12 – Change of authorized representative
• Article 15 – Person for regulatory compliance
• Article 19 – EU declaration of conformity
• Article 27 – Unique device identification system
• Article 29 – Registration of devices
• Article 30 – Electronic system for registration of economic operators
• Article 31 – Registration of manufacturers, authorized representatives, and importers
• Article 32 – Summary of safety and clinical performance
• Article 51 – Classification of devices
• Article 52 – Conformity assessment procedure
• Article 53 – Involvement of notified bodies in conformity assessment procedures
• Article 54 – Clinical evaluation consultation procedure for certain class III and IIb devices
• Article 61 – Clinical evaluation
• Article 62 – General requirements regarding clinical investigations conducted to demonstrate conformity of devices
• Article 83 – Post-market surveillance system of the manufacturer
• Article 84 – Post-market surveillance plan
• Article 85 – Post-market surveillance report
• Article 86 – Periodic safety update report
• Article 87 – Reporting of serious incidents and field corrective actions
• Article 88 – Trend reporting
• Article 89 – Analysis of serious incidents and field corrective actions
• Article 92 – Electronic system on vigilance and on post-market surveillance
• Annex I – General safety and performance requirements
• Annex II – Technical documentation
• Annex III – Technical documentation on post-market surveillance
• Annex VIII – Classification rules
• Annex IX – Conformity assessment based on a QMS and on assessment of technical file
• Annex X – Conformity assessment based on type examination
• Annex XI – Conformity assessment based on product conformity verification
• Annex XIV – Clinical evaluation and post-market clinical follow-up
• Annex XV – Clinical investigations
• Annex XVI – List of groups of products without an intended medical purpose