EUROPE
1. MDCG 2021-26 – Q&A on Repackaging and Relabelling under Article 16 of MDR and IVDR
This guidance provides clarification on the obligations outlined in Article 16(2)–(4) of the MDR (EU 2017/745) and IVDR (EU 2017/746). The Q&A addresses various scenarios involving importers, distributors, and other legal entities performing relabelling or repackaging activities. Topics covered include:
- Applicability of Article 16 to different economic operators
- Whether requirements apply to legacy devices
- Whether splitting bulk shipments constitutes repackaging
- Information required in notifications to manufacturers and competent authorities
- Conditions triggering notification requirements
- Notified body involvement
- Translation requirements for IFUs
- UDI and traceability obligations
2. MDCG 2021-25 – Application of MDR Requirements to Legacy Devices
The MDCG established a task force to interpret transitional provisions under Article 120(3) of the MDR. The related report outlines:
- The task force mandate
- MDR requirements that apply to legacy devices
- Requirements for devices placed on the market before 26 May 2021 under Directives 90/385/EEC and 93/42/EEC
The report was endorsed by MDCG in September 2021 and supports consistent implementation across Member States.
3. Joint Implementation Plan for IVDR
This document presents the joint implementation plan for the IVDR (application date: 26 May 2022). Developed through MDCG review and stakeholder consultation, it identifies priority actions needed to ensure the new regulatory framework functions effectively. The plan is intended as a living document and will be updated as implementation progresses.
UNITED KINGDOM (MHRA)
4. MHRA Public Consultation on Future UK Medical Device Regulation
Following the UK’s exit from the EU, MHRA has launched a comprehensive consultation on future regulatory reforms. Topics include:
- Clinical investigation requirements
- Pre-market assessment processes
- Importer and distributor responsibilities
- Post-market surveillance and vigilance
- Transparency and patient engagement
The goal is to create a modernized, innovation‑friendly regulatory system while ensuring patient safety.
5. Guiding Principles for AI/ML-Based Medical Devices (UK, USA, Canada)
Regulators from the UK, USA, and Canada jointly published ten guiding principles for Good Machine Learning Practice (GMLP). These principles aim to lay the groundwork for international collaboration on AI/ML device development, covering areas such as:
- Research and evaluation
- Education and training
- Harmonized standards
- Regulatory policy alignment
UNITED STATES (FDA)
6. FDA Reiterates Need for IRB Review of IVD Studies Using Human Specimens
FDA issued a reminder that clinical studies involving leftover, deidentified human specimens used for IVD evaluations still require Institutional Review Board (IRB) review. This applies to:
- Studies supporting investigational device exemptions
- Studies supporting marketing submissions
- Technical and analytical performance studies
7. FDA Strengthens Label Warnings for Breast Implants
New labeling requirements include mandatory patient decision checklists and restrictions on sales to providers who commit to informing patients of risks. Physicians and patients must sign the checklist to ensure informed decision‑making.
CANADA (Health Canada)
8. Good Machine Learning Practice for Medical Device Development – Guiding Principles
Health Canada, together with FDA and MHRA, contributed to the development of principles supporting safe, effective, and high‑quality AI/ML-enabled medical devices. These principles promote harmonized expectations across regulatory jurisdictions.
BRAZIL
9. Ministry of Health Guidance on Copper IUD Insertion in SUS
The Ministry of Health recommends that only trained physicians perform IUD insertion due to procedural risks such as bleeding, uterine perforation, bladder injury, and vagal reactions. This measure aims to ensure patient safety and improve quality of care across the public health system.
