the REG-INTEL APP

This summary encapsulates the key elements of the MDR and IVDR, focusing on compliance timelines, regulatory requirements, and the implications for manufacturers and authorities outside the EU.  It provides regulatory authorities in non-EU/EEA countries with essential information on the EU's Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Regulatory Framework Overview

• The MDR (EU 2017/745) and IVDR (EU 2017/746) were adopted in April 2017 to enhance clinical safety and ensure fair market access for manufacturers.
• The MDR replaced the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD), becoming applicable on May 26, 2021.
• The IVDR replaced the In Vitro Diagnostic Medical Devices Directive (IVDD), becoming applicable on May 26, 2022.
• Both regulations are directly applicable across EU Member States, creating a uniform regulatory environment.

Transition Periods and Compliance

• Manufacturers in third countries must understand the timelines and obligations under the MDR and IVDR to avoid market disruptions.
• During transition periods, devices compliant with previous directives (MDD/AIMDD/IVDD) can coexist with those compliant with the new regulations.
• Health institutions and importers should be informed about these requirements to ensure smooth market operations.

Conformity Assessment and CE Marking

• The conformity assessment process varies by device risk class. Class IIa, IIb, and III medical devices, along with certain Class I devices, require notified body involvement.
• A new clinical evaluation consultation procedure for Class III implantable devices and some Class IIb devices involves an independent expert panel.
• Most Class A IVDs can be self-declared, while Classes B, C, and D require notified body involvement for conformity assessment.

Timelines for MDR Compliance

• Class I devices and custom-made devices must comply with the MDR since May 26, 2021.
• Devices that previously did not require notified body involvement under MDD but do under MDR can be marketed until December 31, 2028.
• Legacy devices with valid certificates issued between May 25, 2017, and May 26, 2021, can be marketed until December 31, 2027, or 2028, depending on their risk class.
• Conditions for extended transition periods include applying to a notified body by May 26, 2024, and signing an agreement by September 26, 2024.

Timelines for IVDR Compliance

• Class A non-sterile IVDs must comply with the IVDR since May 26, 2022.
• IVDs that did not require notified body involvement under IVDD but do under IVDR can be marketed until December 31, 2029.
• IVDs with certificates issued under IVDD can be marketed until December 31, 2027, subject to conditions.
• Manufacturers must establish an IVDR quality management system by May 26, 2025, and apply to a notified body by specified deadlines.

Post-Market Surveillance and Clinical Evaluation

• The new regulations enhance post-market surveillance requirements, including periodic safety update reports (PSURs) for all medical devices and IVDs, except Class I and low-risk IVDs.
• Trend reporting is mandated for all devices to monitor significant increases in non-serious incidents or undesirable effects.
• Clinical evaluations must collect clinical data and may involve clinical investigations or performance studies, with stricter rules on equivalence.

Unique Device Identifiers (UDIs)

• The regulations introduce a UDI system to improve device traceability. Manufacturers must assign UDIs and affix UDI carriers to devices and packaging.
• The timeline for affixing UDIs varies by device class, with specific deadlines for different classes of medical devices and IVDs.

EUDAMED Database

• EUDAMED will contain UDI information, device details, economic operators, and post-market surveillance data.
• Access to EUDAMED will be rolled out gradually, with mandatory use expected for some modules in 2026.

Certificates of Free Sale

• EU Member States can issue certificates of free sale for devices with CE marking, based on valid certificates under both the old and new regulations.
• Certificates issued under the MDD/AIMDD and IVDD remain valid until their expiration, even after the new regulations come into effect.