Apple is now a regulatory checkpoint.
From spring 2026, Apple is implementing stricter oversight for health applications that function as medical devices across the US, UK and EEA. Apps that perform diagnosis, treatment or medical monitoring face a higher level of scrutiny.
At a glance
What developers are now required to do.
Apple is moving from a distribution platform to an additional regulatory checkpoint.
Formally declare status
Declare within App Store Connect whether an app qualifies as a regulated medical device and specify the regions where it is available.
Provide regulatory evidence
Submit supporting documentation such as FDA clearance, CE marking, or equivalent approvals.
Increase transparency
Provide clear information regarding intended use, safety instructions, limitations, and full manufacturer contact details.
Meet stringent review standards
Apps will be assessed more closely for clinical validity, data accuracy, and user safety.
Is your app affected?
Tick what applies to your app. This quick check runs only in your browser; nothing is sent or stored.
Why it matters.
Your App Store data must match your official registrations.
Global UDI and its specialist partner network get your app through these new platform checks, including EU Authorized Representative and UK Responsible Person support.
Because Apple now requires formal regulatory evidence and manufacturer transparency, well-managed technical documentation and CE/UKCA marking are essential for approval. We make sure the data you submit to Apple matches the official registrations held in the US, EU and UK, preventing delays or removals from the store.
- Technical documentation and CE/UKCA marking managed
- Regulatory evidence and manufacturer details ready for Apple
- Data submitted to Apple matches FDA, EU and UK registrations
- No delays or removals from the store
Support across the full medical device lifecycle.
Regulatory, quality and technical support, from submissions and QMS to technical files, risk management and audits, delivered by Global UDI with our specialist partner network.
Regulatory
- Regulatory affairs: preparing CE Mark, FDA and international regulatory submissions
- Medical device vigilance and reporting systems
- Regulatory inspection gap analysis
- Site / company representative for regulatory inspections
- Clinical trial / performance evaluation advice, incl. clinical strategy, protocol design, IRB / IEC and Competent Authority submissions, and clinical study report writing
Quality System / QMS
- QMS design, implementation and maintenance to ISO 9001, ISO 13485 and QMSR (Part 820)
- GMP and FDA compliance
- Validation of equipment, processes, test methods, facilities, product software
- Business and computer systems validation, incl. Part 11 and electronic records & signatures
- Process mapping, management review, QMS gap analysis and remediation, design control
Technical File / Design Dossier
- Technical and design file reviews
- Product classification
- Clinical evaluation reports
- Biological safety evaluations
Risk Management
- Risk management (ISO 14971)
- A risk-based approach to meeting your quality and regulatory needs
Audits
- Internal and external auditing
- Supplier approval and audit program implementation and management
- Pre-audit preparations (FDA, MHRA, Notified Body, unannounced)
- Post-audit advice and guidance
- Mock Notified Body / FDA audits
Support activities
- General QA support / advice on ISO 9001, 13485, FDA and EU GxP
- Documentation, change control, validation, CAPA / incident management
- Investor diligence: quality and regulatory due diligence
Other
- Outsourcing organisation
- Training: GMP training with an FDA / MHRA focus
Developing or distributing a medical device app?
Align your regulatory approvals with Apple's new requirements. Book a free 15–30 minute video consultation call and we will identify the gaps between your App Store data and your official registrations.
Book a Free Video ConsultationNo obligation. You get a list of the gaps we find, recommended next steps and a clear scope if you want our help.
