EUROPE

Commission Implementing Regulation (EU) 2021/2226 on Electronic Instructions for Use (eIFU)

The European Commission has established rules defining when medical device instructions for use (IFU) may be provided electronically instead of on paper. Manufacturers may supply eIFUs for:

• Implantable and active implantable devices and their accessories
• Fixed installed devices and their accessories
• Accessories with built‑in systems that visually display IFUs
• Software, where the IFU may be delivered through the software itself

Updated IVDR Transition Timeline

The phased implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR) is now confirmed following an amendment approved by the European Parliament and Council. Transition periods have been extended as follows:

• Class D (highest risk): until May 2025
• Class C: until May 2026
• Class B and Class A sterile devices: until May 2027

This extension aims to prevent shortages, allow manufacturers additional preparation time, and support the availability of notified bodies.

MDCG 2021‑27 – Q&A on Articles 13 and 14 (Importers and Distributors)

This guidance clarifies the responsibilities of importers and distributors under the MDR and IVDR. It distinguishes the two roles based on whether the economic operator places a device on the EU market directly from a non‑EU manufacturer. EU distributors become importers if they obtain devices directly from outside the EU. Practical examples are provided to illustrate common scenarios.

MDCG 2021‑28 – Substantial Modification of Clinical Investigations

Under the MDR, sponsors must notify Member States within one week if they intend to modify a clinical investigation in a way that may significantly impact subject safety, health, rights, or data reliability. The MDCG provides a template for such notifications, although national requirements may vary. The template will be withdrawn once the EUDAMED clinical investigations module is fully functional.

UNITED KINGDOM (MHRA)

Guidance on Use of Real‑World Data (RWD) in Regulatory Decision‑Making

MHRA has issued guidance on the use of RWD—including electronic health records, patient registries, and digital health technologies such as wearables and implantables—to support regulatory assessments. When analysed, RWD forms real‑world evidence (RWE), which can provide valuable insights outside traditional clinical trials.

USA (FDA)

Guidance on Devices for Treating Benign Prostatic Hyperplasia (BPH)

The FDA has issued recommendations for non‑clinical and clinical investigation of devices intended for treating BPH. The guidance aims to ensure consistency and support efficient review of premarket submissions for these devices.

CANADA (HC)

Non‑Payment of 2021 Annual Licence Review Fees – Cancellation of MDELs

Health Canada will cancel medical device establishment licences (MDELs) for companies that have not paid their 2021 annual licence review fees. Once cancelled, the establishment is no longer authorized to manufacture, import, or distribute medical devices and must cease these activities immediately upon receiving the cancellation notice.

ARGENTINA (ANMAT)

Strengthening International Regulatory Engagement

ANMAT participated in the Virtual Forum of the Medical Device Single Audit Program (MDSAP), part of the International Medical Device Regulators Forum (IMDRF), where it holds observer status alongside the UK MHRA and WHO.

ANMAT has also joined three new IMDRF working groups: 

• Artificial Intelligence (led by Korea)
• Good Regulatory Practices (led by the U.S.)
• Cybersecurity (led by the U.S.)

This expanded involvement reflects Argentina’s growing commitment to regulatory convergence. The COVID‑19 pandemic highlighted the critical need for strong global oversight of medical products such as diagnostics, PPE, and ventilators.

ANMAT continues to strengthen its global presence through participation in: 

• IMDRF (observer member)
• MDSAP (affiliate member)
• PAHO medical product working groups
• Mercosur (COPROSAL SGT No. 11)
• WHO’s mechanism on substandard and counterfeit medical products