Essentials of European Medical Device Regulatory Affairs

• Regulation rather than a directive - to improve consistency in interpretation • Introduction of a risk based classification system for IVD’s. • Inclusion of some new classes of MDs - e.g. like products utilizing non-viable cells of human origin • Clarify: • Regulatory status of some borderline products • Basic concepts related to clinical investigation and evaluation • Requirement for Increased testing of marketed devices • Strengthening oversight of NBs - improve consistency • Improvements in monitoring performance in the market of MDs e.g. like central reporting of incidents by manufacturers • Improved coordination of CAs in the areas of vigilance and market surveillance • more audits of manufacturing sites with unannounced inspections • Improved traceability - throughout the supply chain • EC will chair and provide logistical and technical support for the new MD Coordination group (MDCG). • Rolling introduction of implanting acts. NB requirements, Eudamed, UDI. Main changes (not all)

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Current products need to comply to MDR

2014 Device No.1 Certified under  current MD  Directive

2019  Device No.1 Re‐certified  under current  MD Directive

2023 Device No.1 Certified under  new MD  Regulation

2016  Device No.2 Certified under  current MD  Directive

2021  Device No.2 Certified under  new MD  Regulation

2014

2015

2017

2019

2021

2023

2025

Early 2017 Regulations formally adopted and enter into force

Q1 2019 NBs 1 st wave re-

Late 2023 Devices placed on EU market must be certified under new MDR

Q1 2017 NB to start assessing

Late 2019 MDR fully applied

designation, can only issue MDR certs – NB here

against MDR requirements but no new cert to be issued

Q1 2017 to Q1 2019 2 years of pre-assessment to manage

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