Medical Device Regulatory Update: July & August 2026 - Medical Device made Easy Podcast | Lyssna här

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

Swissmedic – swissdamed Registration Obligation

From 1 July 2026, manufacturers and authorised representatives must register relevant devices, systems, and procedure packs in the swissdamed UDI Devices module.

The general transition period ends on 31 December 2026, making data preparation, responsibility allocation, and reconciliation important operational priorities for companies active in Switzerland.

🇬🇧 MHRA Guidance on Ambient Voice Technology

Read the MHRA Guidance

The MHRA provides useful clarification on when ambient voice technologies, including clinical scribes, may fall within medical device regulation.

Pure transcription or clinician-reviewed administrative summaries may remain outside medical device qualification, while diagnostic insights, treatment recommendations, or medical-performance claims can create a medical intended purpose.

🇺🇸 FDA FY 2027 Medical Device User Fees

FDA FY 2027 Medical Device User Fees

FDA published its FY 2027 medical device user fee notice, covering submission fees, establishment registration, small-business reductions, and related payment procedures.

The new fee year applies from 1 October 2026 through 30 September 2027, making the actual submission receipt date an important consideration when planning budgets.

🇮🇳 CDSCO Medical Device Software Guidance

Read the CDSCO Medical Device Software Guidance

India's CDSCO guidance covers qualification, classification, QMS, technical documentation, clinical evidence, AI-enabled software, cybersecurity, lifecycle change control, and post-market monitoring.

One important message for global manufacturers is that an EU or US classification rationale shouldn't simply be reused without mapping the device and evidence to the Indian framework.

🇸🇬 Singapore Updates Medical Device Cybersecurity Guidance

Singapore HSA Medical Device Guidance

Singapore HSA published an updated Best Practices Guide on Medical Device Cybersecurity in August 2026.

For connected medical devices and software manufacturers, it provides another useful benchmark for secure development, vulnerability management, updates, and post-market cybersecurity activities.

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The episode also highlights upcoming opportunities covering Article 117, MDR/IVDR, biocompatibility, AI, clinical evidence, PMS, vigilance, digital health, and African medical device regulation.

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