This week in global device regulatory news, the European Commission rolled out MIR Form v7.3.1 for MDR/IVDR incident reporting, Switzerland advanced streamlined review for FDA-cleared devices, Peru created the autonomous Apemed authority to replace Digemid, and China issued new quality standards for online medical‑device sales and released registration‑review guidelines for ten products.
On May 5, 2025, the European Commission published Version 7.3.1 of the Manufacturer Incident Report (MIR) form, along with revised Help Text guidance. These updates ensure alignment with the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and include additional guidance for managing legacy devices. The updated form will be mandatory starting November 2025 for reporting serious incidents under both regulations.
🔗 Official Publication & Downloads: EU Commission MIR and PMSV Reporting Forms Page
Key Modifications in MIR v7.3.1:
Learn more about EU MDR and IVDR consulting.
On April 30, 2025, the Swiss Federal Council outlined implementation steps for Motion 20.3211, enabling medical devices approved by non-European regulators, especially the US FDA, to enter the Swiss market. Under a simplified assessment, Swiss private CABs will oversee compliance with additional national requirements, including data protection, quality systems, PMS plans, and clinical evidence if needed. No official timeline for implementation has been set.
Official Sources:
Learn more about Switzerland Medical Device Registration.
The Peruvian government has approved the creation of the National Authority for Pharmaceutical Products, Medical Devices, and Health Products (Apemed), a new autonomous regulatory body replacing Digemid. Apemed will ensure the safety, quality, and efficacy of health products in Peru, marking a major step toward becoming an internationally recognized regulatory authority. This initiative aims to modernize the health system, protect public health, and boost pharmaceutical industry competitiveness.
Learn more about DIGEMID Peru Medical Device Registration.
The National Medical Products Administration has released the "Quality Management Standards for Online Sales of Medical Devices," set to take effect on October 1, 2025. These new regulations aim to enhance quality control and safety across online sales channels by standardizing operations for both medical device sellers and e-commerce platforms. The Standards mandate clear business and product information, robust quality systems, and comprehensive risk management. This initiative marks a significant step toward ensuring safe and reliable access to medical devices for consumers and promoting the healthy development of the digital health industry.
The Medical Device Evaluation Center of the National Medical Products Administration has issued new registration review guidelines for 10 medical devices, including the "Type I Collagen Cartilage Repair Products" guideline. This release aims to standardize the review process and improve the regulatory framework for various medical devices, such as orthopedic implants and dental materials. The updated guidelines will ensure more efficient, transparent, and consistent evaluation procedures, contributing to better management and safety of medical devices in China.
Learn more about China Medical Device Registration & Approval.
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