Transitional Provisions for Medical Devices and IVDs in France under EU MDR/IVDR

Background and Purpose

Following the adoption of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), France applies transitional measures to allow a phased shift from the previous Directives (93/42/EEC MDD, 90/385/EEC AIMDD, 98/79/EC IVDD) while ensuring patient safety. These provisions extend certificate validity and permit continued placing on the market under certain conditions during defined transition periods. The ANSM provides this reference document to clarify application in France, incorporating EU amendments (e.g., Regulation (EU) 2023/607 for MDR extensions). Dispositions transitoires - ANSM

Transitional Provisions for Medical Devices (MDR)

Legacy Devices (MDD/AIMDD certified)

• Devices with valid MDD/AIMDD certificates issued before 26 May 2021 may continue to be placed on the market until the certificate expiry date, extended under specific conditions:
  • Class III implantable and Class IIb active devices intended to administer/remove medicines: valid until 31 December 2027 (or 31 December 2028 if certificate issued after 26 May 2021).
  • Other Class III and implantable Class IIb devices: valid until 31 December 2028.
  • Class IIb non-implantable, Class IIa, Class I sterile/measuring: valid until 31 December 2028.
• Devices must continue to comply with MDD/AIMDD requirements and not be significantly changed.
• Manufacturers must have a quality management system compliant with MDR Article 10(9) by the transition end and lodge a formal application with a notified body by deadlines (e.g., 26 May 2024 for higher-risk classes).

Class I Self-Certified Devices

• Devices self-certified under MDD that require notified body involvement under MDR may continue until 26 May 2024 if the manufacturer lodges an application by 26 May 2024.

Transitional Provisions for IVDs (IVDR)

Legacy IVDs (IVDD certified)

• IVDs with valid IVDD certificates or declarations of conformity issued before 26 May 2022 may continue to be placed on the market until:
  • Class D: 26 May 2025 (or certificate expiry if later).
  • Class C: 26 May 2026.
  • Class B and A sterile: 26 May 2027.
• Continued compliance with IVDD and no significant changes required.
• For Class D and certain Class C devices, specific conditions apply (e.g., performance study results or ongoing procedures).

Self-Certified IVDs

• Class A non-sterile IVDs transition directly to IVDR without legacy provisions.
• Other self-certified IVDs requiring notified body assessment under IVDR may continue under similar timelines as above if application lodged timely.

Common Requirements During Transition

• Continued vigilance and post-market surveillance obligations under legacy Directives.
• No significant changes to design or intended purpose allowed without full MDR/IVDR compliance.
• Manufacturers must implement MDR/IVDR-compliant QMS progressively.
• Notified bodies must prioritize legacy device assessments during transition.

Practical Implications in France

• ANSM monitors compliance and may request additional information or impose restrictions.
• For legacy devices, economic operators (importers, distributors) must verify continued conformity.
• Transition periods do not apply to new devices; full MDR/IVDR compliance required from 26 May 2021 (MDR) / 26 May 2022 (IVDR).
• Manufacturers encouraged to plan early migration to avoid supply disruptions.

These transitional measures balance innovation access with safety during the regulatory shift. Dispositions transitoires - ANSM