Medical Devices Compliance Updates Newsletter August 2025

Key Points

• Requirements for assembly and labelling
• Responsibilities of businesses based in Switzerland
• Rules for systems and packs used for medical purposes
• Reference to broader rules for individual medical devices

Why It Matters:

Since Switzerland is not part of the EU MDR framework, the compliance rules are different. This guidance helps ensure that medical device combinations are safe, traceable, and meet legal standards in clinical settings.

Key Takeaway for the Industry

The Swissmedic guidance underscores that compliance doesn't stop at the individual device level. Assemblers play a vital role in the supply chain and carry significant responsibility. The requirement for a CH-REP for foreign-assembled SPPs is a critical compliance step specific to the Swiss market that cannot be overlooked.

At Sushvin Consultancy, we assist global manufacturers in understanding Swiss-specific processes, including authorized representation, documentation, and post-market obligations.

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Switzerland Adopts New EU Rules for Electronic Instructions for Medical Devices

Swissmedic, the Swiss Agency for Therapeutic Products, announced that it will start using the EU's new rules on electronic instructions for use (eIFU). EU Commission Implementing Regulation on the electronic provision of instructions for use (eIFU) for medical devices will bring Switzerland into closer regulatory alignment with the EU MDR. This change will make things easier for manufacturers and provide better, more sustainable information for healthcare workers.

Key Takeaways:

• eIFU now permitted for eligible devices in Switzerland
• Paper IFUs may be omitted under defined conditions
• Digital access must meet safety, usability, and accessibility standards

For manufacturers and regulatory teams operating across EU and Swiss markets, this streamlines compliance and supports digital-first strategies in device labeling and post-market documentation.

Next Steps for RA/QA Teams:

• Assess device eligibility under MDR Annex I
• Update technical documentation and risk assessments
• Ensure eIFU platforms meet regulatory and user requirements

This is a strategic shift toward harmonized, tech-enabled compliance across Europe.
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At Sushvin Consultancy, we assist global manufacturers in understanding Swiss-specific processes, including authorized representation, documentation, and post-market obligations.
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Highlight of the guidance

• Clearer Instructions for Foreign Companies: The guidance now provides better information for foreign businesses seeking small business status, supporting global standards.
• Simplified Document Requirements: Applicants need to submit a Small Business Qualification Request (SBQR), including financial documents, ownership details, and tax records.
• Set Timelines: The FDA recommends submitting requests 90 days before the first user fee is due for a timely decision.
• Easier Digital Submissions: There is improved support for electronic submissions through the FDA’s Unified Registration and Listing System (FURLS).

Criteria to be considered as a small business:

The FDA defines a small business based on its sales or gross receipts, with different limits for various benefits:

• Reduced application fees: Sales of $100 million or less (including affiliates).
• First application fee waiver: Sales of $30 million or less (one-time benefit).
• Registration fee waiver: Sales of $1 million or less, plus proof of financial hardship (e.g., active bankruptcy).

Key Benefits for Small Businesses

For small medical device companies, qualifying as a small business can lower Premarket Notification (510(k)) fees by up to 80%. This reduction can help budgeting especially for innovative startups in AI diagnostics, software as a medical device (SaMD), and digital therapeutics.

How to apply for U.S. Businesses

Submit a MDUFA Small Business Request (SBR) through the CDRH Portal. Include:

• A recent federal tax return (signed, including affiliate returns).
• Your Organization ID (Org ID) from the FDA’s User Fee System.
• Foreign affiliates need a National Taxing Authority Certification.

For Foreign Businesses

• Fill out a MDUFA Foreign SBR and submit it to your country’s tax authority for certification.
• Provide proof of income in both USD and local currency.

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FDA’s New Guidance on PCCPs for AI-Enabled Devices: A Change in Regulatory Approach

The FDA's new guidance on Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) is an important step in regulating software for artificial intelligence-enabled devices. This guidance helps developers and regulatory teams understand how to manage changes in adaptive algorithms effectively.

What is a PCCP and it’s important?

A PCCP is a proactive regulatory tool that lets manufacturers approve certain software updates like changing algorithms or improving performance during the initial marketing submission.

Key Components of a PCCP

The FDA identifies three main parts of a PCCP:

• Description of Modifications: What changes are expected? This can include updating algorithms, changing input data, or tuning performance.
• Modification Protocol: How will changes be developed, tested, and put into action? Sponsors must explain their testing processes, version control, and strategies to manage risks.
• Impact Assessment: What are the overall effects of these changes? Sponsors must show that updates won’t harm safety, introduce bias, or stray from the intended use.

Strategic Implications for Industry

For manufacturers and consultants, this guidance is not just a procedural update it’s a strategic advantage. It allows for:

• Quicker updates for AI models.
• Less regulatory hassle for predictable updates.
• Enhanced performance after-market launches through real-world learning.

Final Thoughts

As AI continues to change healthcare, regulators are adapting as well. The PCCP framework represents a shift towards a more flexible oversight approach that balances innovation with responsibility.

At Sushvin Consultancy, we help clients incorporate PCCPs into their regulatory strategies, ensuring that adaptive AI leads to proactive compliance.

If you need help drafting your PCCP or aligning your AI plans with FDA expectations, let's connect. Visit us
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What’s Covered:

• SaMD: Software performing medical functions independently
• Digital Therapeutics (DTx): Software designed to treat or alleviate disease
• AI/LLMs: Tools like ChatGPT or Bard used for medical purposes

What’s Not Regulated?

• General wellness apps without medical claims.
• Clinical Decision Support Software ( CDSS)

Key Updates from the TGA Guidance:

• Baby movement apps are now classified as medical devices due to clinical risk
• SaMD using consumer hardware (e.g., smartphone sensors) must be validated
• AI developers must show training data quality and clinical performance
• Flowcharts and FAQs help clarify regulatory status
• Cybersecurity and international alignment (IMDRF) are emphasized

At Sushvin Consultancy, we specialize in helping digital health innovators navigate SaMD classification, clinical validation, and global compliance from TGA to MDR and FDA.

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Read the full guidance

TGA Mandates Adverse Event Reporting by Healthcare Facilities: A New Standard for Device Vigilance

Australia’s Therapeutic Goods Administration (TGA) has introduced mandatory reporting requirements for medical device adverse events. The new guidance mandates all public, private, and day hospital facilities to must report medical device adverse events.

Key Legislative Details

• Therapeutic Goods Act 1989 amended in March 2023
• Supporting regulations enacted in March 2025
• A 2017–18 Senate Inquiry into transvaginal mesh implants found delays in recognizing device risks.
• Applies to public, private, and day hospitals across Australia
• General practices and aged care facilities are currently excluded

What Must Be Reported

• Adverse events: Death, serious injury, or deterioration linked to a device
• Near misses: Incidents that could have caused harm but were prevented
• Treatment outcomes: When treatment is required due to device-related issues.

How to Report

Reports are submitted via the ASDER system (Adverse Signal Detection and Event Reporting), which is distinct from the IRIS system used by sponsors and professionals.

Timeframes:

• 10 days for serious events
• 45 days for near misses and treatment-related events

Reports must include:

• Device name and model
• Incident description
• Relevant dates and outcomes

Data Integration & Impact

The ASDER system enables early signal detection and trend analysis, complementing voluntary reports from IRIS.

Final Thoughts

The TGA’s move toward mandatory adverse event reporting by healthcare facilities reflects a global trend: regulators are demanding more proactive, real-world vigilance. For device manufacturers, sponsors, and hospitals, this is a call to strengthen collaboration and transparency.

At Sushvin Consultancy, we’re here to help clients navigate this transition with clarity, confidence, and compliance.

Need help aligning your facility’s reporting systems with TGA expectations? Let’s connect. Visit us
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