Medical Devices Compliance Updates Newsletter July 2025

• Key parts of the EU AI Act, including definitions, obligations, and scope
• Risk-based classification of AI systems in healthcare, focusing on "high-risk" categories
• How the EU AI Act aligns with EU MDR, highlighting conformity assessment pathways
• Strategic insights for notified bodies and manufacturers working on Software as a Medical Device (SaMD), Clinical Decision Support Systems (CDSS), and AI diagnostics

This regulatory shift means that MedTech innovators need to develop flexible strategies to meet new compliance demands without losing speed or quality.

Strategic Insights for MedTech Stakeholders

At Sushvin Consultancy, we see this change as an opportunity for better and more reliable AI in healthcare. The EU AI Act emphasizes transparency, accountability, and human oversight, aligning with global principles.

Important insights include:

• Clear communication in multiple languages will be crucial for compliance in different EU countries
• Early identification of risks and documentation of use cases can help avoid regulatory delays
• Collaboration with notified bodies on conformity assessments should start early
• Modular design could help developers separate core AI functions from clinical interfaces

Whether you are a MedTech innovator or manufacturer, Sushvin Consultancy can assist with:

• Gap analyses between AI Act and MDR requirements
• Multilingual translations of compliance documents for EU submission
• Global alignment strategies for UK MHRA, US FDA, and APAC regions
• Planning AI diagnostics and CDSS tools for regulatory compliance

Final Thoughts

The EU AI Act marks a significant change in how artificial intelligence is regulated in healthcare, where patient outcomes and ethical design are critical. TÜV SÜD’s white paper serves as a guide for navigating this new landscape with insight and accuracy. Read the full white paper

EU UDI Update: New Regulation (EU) 2025/788 for Contact Lens Manufacturers

On 28 July 2025, the European Commission published Delegated Regulation (EU) 2025/788 in the Official Journal of the European Union (OJEU), officially amending Regulation (EU) 2023/2197. This long-awaited update defers the application date of Master UDI-DI requirements for contact lenses by one year, now set for 9 November 2026.

The extension aims to:

• Give manufacturers more time to align their data systems with EUDAMED requirements.
• Ensure safety and traceability for Class IIb/III contact lenses.
• Make it easier for companies to access the EU market while reducing regulatory pressure.

If you are exporting contact lenses to the EU, here’s what this change means for you:

• You now have until November 9, 2026, to comply.
• Update your internal systems to reflect Master UDI-DI for contact lenses.
• Prepare necessary documents for EUDAMED, including UDI submissions and technical files.
• Work with your notified bodies and distributors on labeling changes.
• This delay also allows you to work with regulatory consultants and improve UDI strategies in various markets, including the UK, US, and Asia-Pacific.

Final Thoughts

The new regulation (EU) 2025/788 shows the EU's commitment to patient safety through product traceability while considering industry challenges. The one-year extension is not just a delay; it’s a chance to develop better compliance solutions. To read more visit

Sushvin Consultancy’s Perspective- At Sushvin Consultancy, we see this update as a valuable pause—an opportunity to enhance readiness, reduce compliance errors, and align global tracking practices. We assist manufacturers by clarifying MDCG guidance and translating regulatory requirements into easy-to-understand formats.

EU Medical Device Regulation Reform: A Call for Centralization and Consistency July 2025

The Heads of Medicines Agencies (HMA) and the Competent Authorities for Medical Devices (CAMD) have released a joint statement urging important changes to the EU medical device rules. Supported by officials from 17 European countries, the statement focuses on improving coordination, governance and harmonized regulatory processes across the European medical device landscape.

Key Points from the Statement

• A move toward more consistent rules across Member States
• Streamlined oversight of notified bodies and safety assessments
• Smarter, risk-based approaches to accelerate access to innovation
• Simplified compliance for SMEs
• Sustainable funding to strengthen the regulatory system long term

Next Steps

The European Commission will review possible legislative changes to enable centralization. A detailed plan for implementation is expected soon. Industry stakeholders should get ready for possible changes in compliance and approval processes.

Final Thoughts

This statement indicates a significant change in how medical devices will be regulated in the EU. As more information becomes available, companies should:

• Keep an eye on updates regarding centralized governance.
• Engage with regulators as new frameworks are developed.
• Prepare for potential changes in compliance strategies.

What do you think? Will centralization improve the EU medical technology landscape, or could it lead to new challenges? Share your thoughts with us here

EMA Launches IRIS Applicants Guide v3.8 – Published 11 July 2025

The European Medicines Agency (EMA) has released the latest version of its IRIS Guide for Applicants (v3.8). This 120-page manual which provides step-by-step instructions for using the IRIS platform for regulatory submissions.

What’s New in v3.8?

• Core Process Enhancements: Easier navigation for draft and ongoing submissions, including better sorting, searching, and clarity on withdrawal steps.
• RPI and SPOR Workflows: Improved instructions for requesting, transferring, and updating Research Product Identifiers (RPIs) to align with the SPOR system.
• PRIME Applications: Clear processes for PRIME eligibility, updates, meeting requests, and transferring regulatory rights.
• Paediatric Drug Development: Detailed guidance for Pediatric Investigation Plans (PIPs), waivers, compliance checks, and reporting requirements.
• Marketing Status & Parallel Distribution: New options for bulk and single uploads of marketing-status notifications and easier parallel distribution submissions.
• SPOC Roles & Inspections: Complete workflows for industry Single Points of Contact, coordination of GMP/GCP inspections, document uploads, and order tracking.

Why It Matters

• Regulatory Teams: Standardized processes for quicker, more reliable submissions.
• Product Owners: Improved tracking of RPIs and PRIME entitlements for better change management.
• Small-Medium Enterprises & Academia: Support for SMEs and orphan drugs which reinforces EU innovation.
• Compliance & Quality: Improved modules for paediatric and inspections which make submissions stronger.

Final Thought

EMA’s IRIS v3.8 is a significant upgrade that is both technical and strategic. If involved in regulatory operations, clinical product management, or consulting for SMEs, this guide is important for streamlining EU filings.

EU Adopts Decision (EU) 2025/1324 – Strengthening Expert Panels for High-Risk Medical Devices

On 7 July 2025, the European Commission adopted Implementing Decision (EU) 2025/1324, amending the foundational Decision (EU) 2019/1396 on expert panels for medical devices. This update reinforces the EU Medical Devices Regulation (MDR 2017/745) framework, emphasizing scientific rigor, transparency, and patient safety.

For manufacturers, notified bodies, and healthcare stakeholders, understanding these changes is critical for compliance and market access.

What’s New in Decision (EU) 2025/1324?

The latest amendment introduces structural and operational enhancements to improve efficiency and expertise.

• New Pediatric & Rare Diseases Panel
Dedicated experts for children and rare conditions (addressing gaps in device development).
• Streamlined Operations
Clearer rules on panel composition, term limits, and sub-group formation.
• Conflict of Interest (CoI) Management
Stricter transparency requirements for panel members.
• Faster Turnarounds
Defined timelines for scientific advice publication (reducing delays).
• EMA’s Central Role
The European Medicines Agency (EMA) remains the secretariat for coordination.

Final Thought

As the EU MDR framework advances, the role of expert panels becomes increasingly central to evidence-based decision-making. The adoption of Decision (EU) 2025/1324 signals a proactive step toward regulatory agility, scientific rigor, and patient-centric innovation.

EU Opens Public Consultation on EudraLex Volume 4 – GMP Guidelines

Consultation Period: July 7 – October 7, 2025
Organized by: European Commission, DG Health and Food Safety
The European Commission has started a public consultation to gather opinions on three important updates to EudraLex Volume 4, which covers Good Manufacturing Practice (GMP) Guidelines:

What’s Being Reviewed:

• Chapter 4 – Documentation
• Focuses on managing data, using different systems, and keeping track of information over time.
• Introduces a risk-based approach to controlling documents in paper, digital, and multimedia forms.
• Annex 11 – Computerized Systems
• Expands to cover cloud technology, artificial intelligence (AI), mobile apps, and the Industrial Internet of Things (IIoT).
• Enhances rules for validation, cybersecurity, audit trails, and monitoring suppliers.
• New Annex 22 – Artificial Intelligence
• This is the first EU GMP guidance specifically for AI and machine learning in pharmaceutical manufacturing.
• Discusses model selection, training, validation, performance metrics, and the importance of human oversight.

Final thought:

These updates aim to update GMP expectations to keep pace with digital changes, ensure data integrity, and integrate AI, all while maintaining consistent regulations and product quality.

Stakeholders are invited to share their feedback using the EU Survey tool by October 7, 2025. Access the official consultation page

TEAM NB- Navigating the Future: Notified Bodies' Governance Vision for EU Medical Device Regulation

The EU medical device industry is facing important changes. Although the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) have determined goals, there are still issues like fragmentation and inconsistent application of rules. In a key paper released in July 2025, the Notified Bodies Coordination Group for Medical Devices (NBCG-Med) and Team-NB suggest a new governance model to tackle these problems. Here’s what you need to know.

Need for Central Coordination

The current regulatory environment suffers from duplication, delays, and uneven enforcement. To solve this, the paper suggests creating a Medical Device Coordination Office (MDCO) at the EU level, which would:

• Streamline the designation and oversight of notified bodies.
• Harmonize classification and qualification decisions.
• Develop technical and clinical guidance.
• Facilitate early discussions for innovative devices.
• Coordinate vigilance activities.

The MDCO would simplify the existing system without adding more bureaucracy.

Special Pathways for Innovation

Some devices, like those for pediatric or rare conditions, face unique challenges. The paper proposes Special Pathways under MDR/IVDR, which include:

• Pre-Certification Pathway: A structured route for devices needing more evidence, allowing conditional approval with requirements for post-market data collection.
• Early Advice Pathway: Guided consultations to help manufacturers with data generation.
• Regulatory Learning: Insights from these pathways could lead to new guidance for continuous improvement.
• Confidentiality is crucial, with all discussions protected under EU data rules.

Sustainable Funding for the Future

The success of the MDCO depends on proper funding. A mixed funding model is suggested, combining EU budget allocations with small fees for services like early advice or notified body designations. This ensures long-term stability without overburdening stakeholders.

Strategic Reflection from Sushvin Consultancy

At Sushvin Consultancy, we believe this governance proposal offers:

• A proactive approach to building trust among stakeholders
• A clear path for compliance with SaMD and CDSS
• A foundation for interoperability between MDR, IVDR, and new AI laws

For more details visit

Team-NB Publishes Position Paper on Orphan IVDs

On July 17, 2025, Team-NB released a Position Paper about Orphan In-Vitro Diagnostic (IVD) Medical Devices. This paper addresses an important issue in the IVDR (EU) 2017/746: the lack of rules for orphan IVDs that help diagnose rare diseases.

With 1 in 2000 people in the EU affected by rare conditions, these devices face special challenges in meeting requirements for clinical evidence before they can be sold, while also needing to ensure patients can access them quickly.

Key Takeaways from the Position Paper

Defining Orphan IVDs

The IVDR does not clearly define orphan IVDs. Team-NB suggests: "An orphan IVD is used to diagnose, treat, or prevent diseases affecting 1 or fewer people in 2,000 in the EU, where no suitable alternative exists or where the device provides significant help."

Flexible Clinical Evidence Requirements

Because patient groups are small, the evidence needed before marketing should be reasonable. Acceptable evidence includes:

• Non-clinical data (like AI simulations or lab studies)
• Data from previous IVD uses
• Information from off-label uses (if widely accepted)
• Plans for follow-up after the product is on the market to fill data gaps

Importance of Post-Market Surveillance (PMS)

Strong PMS plans are important since pre-market data might be limited.

Role of Expert Panels

Manufacturers can consult with expert panels from the EMA for:

• Confirmation of orphan IVD status
• Guidance on clinical evidence strategies
• Input on post-market study designs

Next Steps for Manufacturers

• Engage early with NBs and expert panels to confirm orphan status.
• Use alternative data sources (like AI and registries).
• Develop strong follow-up plans to address evidence gaps.

Final Thought

This paper is a significant step towards ensuring that life-saving devices reach patients with rare diseases.Full Position Paper

Team-NB Releases Code of Conduct v5.1 – Harmonization Across EU Notified Bodies

On June 25, 2025, Team-NB released Version 5.1 of its Code of Conduct for Notified Bodies (NBs). This update helps ensure that the European CE certification process under the Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746) is done consistently and transparently.

Purpose of the Code

The Team-NB Code of Conduct is a promise by Notified Bodies to:

• Standardize audit expectations and processes
• Promote transparency and integrity in regulations
• Build confidence in NB operations across Member States
• Align with EU laws and guidelines

What’s New in Version 5.1?

While not a complete overhaul, version 5.1 includes important updates that reflect recent regulatory developments.

• Audit Planning Clarity: Clearer guidelines on how long audits should take, their scope, and resource use
• Subcontractor Oversight: Stronger rules regarding third-party evaluators and subcontracted services
• Unannounced Audit Expectations: Better instructions on how and when these audits should take place
• Annex VII Integration: Closer alignment with the requirements in Annex VII of the MDR/IVDR
• Competence & Training: More emphasis on keeping qualified personnel for all certification activities

Practical Implications

For manufacturers and regulatory teams, this update highlights the need to be ready for audits at any time, not just for scheduled ones. It also offers a consistent approach when working with multiple NBs or preparing for surveillance audits.

Final Thoughts

As the regulatory landscape evolves with changes in digital health, AI, and cross-border trade, shared commitments like the Team-NB Code of Conduct are crucial for building trust and consistency in operations. Read the full document

Software Qualification under IVDR-V2-20250627 – Insights from Team-NB’s Latest Position Paper

With Regulation (EU) 2017/746 continuing to redefine the in vitro diagnostic (IVD) landscape, Team-NB has released its second position paper on software qualification, offering fresh clarity for manufacturers, regulatory affairs professionals, and notified bodies.

Why it’s important: Under the IVDR, nearly 80% of IVDs now require NB involvement— including software that influences diagnostic outcomes. However, manufacturers have faced continuous uncertainty despite MDCG 2019-11.
This updated position offers:

• Refined qualification decision flowcharts
• Definitions for MDSW, expert systems, and software modules
• Clear examples distinguishing qualified vs. non-qualified software
• Guidance on standalone, accessory, and embedded software paths

Highlights at a Glance

• Software analyzing biological parameters (e.g., NGS tools) may qualify as IVD MDSW
• Administrative tools (e.g., LIMS, inventory systems) generally do not
• Emphasis on software intent and functionality to guide qualification
• Harmonization of NB expectations across EU member states

To read more visit

Final thought:

Whether you're evaluating borderline software, drafting a technical file, or preparing for NB visit—this paper is a must-read. It bridges regulatory gaps, supports harmonized classification, and empowers teams with actionable guidance.