Medical Device Regulatory Update: July & August 2026

Medical device regulation continues to evolve across multiple markets. For manufacturers, the challenge isn't simply following every new publication—it's understanding which developments require action, which ones need monitoring, and how they affect existing regulatory strategies.

This latest Medical Device Made Easy regulatory update reviews selected developments from July and August 2026 across Europe, Switzerland, the UK, United States, India, Singapore, and Brazil.

🇪🇺 UDI Assignment Under Distributor Branding

Read MDCG 2026-5 – UDI Assignment

MDCG 2026-5 addresses situations where the same medical device is sold under both the manufacturer's brand and a distributor's brand.

Different UDI-DIs may be appropriate, but when the original manufacturer remains the legal manufacturer, the codes must remain assigned by and linked to that manufacturer. This makes existing private-label arrangements, UDI structures, EUDAMED records, and agreements worth reviewing.

🇪🇺 Notified Body Certification & Fee Transparency

Team-NB MDR Certification Process v2.1

European Commission Notified Body Fee Directory

Team-NB's updated consensus paper maps the MDR certification journey from pre-application and quotation through conformity assessment, certification, and surveillance.

Combined with the European Commission's consolidated directory of Notified Body fee pages, these resources can help manufacturers better understand both the certification process and the costs that need to be considered when planning market access.

🇨🇭 swissdamed Registration Becomes Mandatory