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Patient Guard Limited

Name: Patient Guard Limited
Address: Lancaster House, Amy Johnson Way, Blackpool, FY42RP, GB
Telephone: +441253966900

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Patient Guard Limited

Patient Guard provides Medical Device Regulatory Affairs and Quality Assurance Services

02/09/2026

September Regulatory Roundup is here

Stay up to date with the latest medical device, IVD and digital health regulatory developments.

The September 2026 edition of The Regulatory Roundup is now available, with this month’s focus on NHS DTAC, clinical safety and NHS procurement readiness.

Inside this edition:
🔹 Latest UK regulatory update from the MHRA
🔹 New and updated standards issued in August 2026
🔹 Key developments affecting medical device and digital health organisations
🔹 Practical insights, resources and training from Patient Guard
🔹 Guidance to help you stay compliant, reduce risk and prepare for what’s next

📖 Read the September Regulatory Roundup →
https://mailchi.mp/083da55b257a/may-2024-news-letter-8341758

Keep informed. Stay compliant. Be ready for what’s next.

01/09/2026

Quality starts with understanding the system behind it.

Whether you're new to quality management or want to strengthen your understanding of ISO 9001, the Patient Guard ISO 9001 Basic Training Course provides a practical introduction to the fundamentals of quality management.
The course can help you understand the principles behind an effective Quality Management System and how the requirements of ISO 9001 translate into practical quality activities.

A strong quality culture doesn't happen by accident.

It starts with people understanding:
✔ What quality means
✔ Why processes matter
✔ How risks and opportunities are managed
✔ How continual improvement works
✔ How a QMS supports an organisation

Ready to strengthen your quality knowledge?
Explore the Patient Guard ISO 9001 Basic Training Course → https://patientguard.com/iso-9001-basic-training/

28/08/2026

Friday FAQ: Is a CPSR legally required?

Yes.

Every cosmetic product placed on the Great Britain market must have a Cosmetic Product Safety Report (CPSR) prepared by a suitably qualified Safety Assessor.
Without a compliant CPSR, your cosmetic product cannot be considered fully compliant with the UK Cosmetics Regulation, potentially preventing it from being legally marketed.

View weekly video:
https://youtube.com/shorts/udJP4_5AOrw?feature=share

Read weekly blog:
https://patientguard.com/ivdr-post-market-performance-follow-up-pmpf/

26/08/2026

Medical device software must be developed with a structured, documented lifecycle—and IEC 62304 provides the internationally recognised framework for doing exactly that.

Our practical IEC 62304 Software Lifecycle Checklist helps software teams review the essential stages of software development, from planning and requirements through verification, maintenance and risk management.

Whether you're developing embedded software or Software as a Medical Device (SaMD), this resource can help support a more compliant development process.

📥 Read the guide and download the checklist here:
https://patientguard.com/iec-62304-explained-medical-device-software-development-guide/

25/08/2026

CE marking isn't the finish line. 👀

Under the IVDR, manufacturers need to continue demonstrating that their IVD remains safe, effective and performs as intended throughout its lifecycle.

That's where Post-Market Performance Follow-up (PMPF) comes in.

PMPF helps manufacturers use real-world performance data to:

🔹 Monitor ongoing performance
🔹 Identify emerging risks
🔹 Support performance evaluation
🔹 Keep technical documentation up to date
🔹 Demonstrate continued IVDR compliance

But what does a compliant PMPF strategy actually involve?

🎥 Watch this week's Patient Guard video for a quick introduction to IVDR PMPF and why it matters.

📖 Want the full picture? Read this week's blog for a more detailed guide to Post-Market Performance Follow-up and its role in your IVDR compliance strategy.

View weekly video:
https://youtube.com/shorts/udJP4_5AOrw?feature=share

Read weekly blog:
https://patientguard.com/ivdr-post-market-performance-follow-up-pmpf/

Need help navigating IVDR performance evaluation and PMPF requirements? Get in touch with Patient Guard — we're here to help you keep your regulatory documentation strong throughout your product's lifecycle.

21/08/2026

Friday FAQ: What is Scientific Validity under the IVDR?

Scientific Validity demonstrates that there is a proven scientific relationship between the analyte or biomarker measured by your IVD and the disease, physiological condition, or clinical state defined within its intended purpose.
It's the first of the three mandatory pillars of Performance Evaluation and provides the scientific foundation for your device's claims.

Without strong Scientific Validity, the rest of your Performance Evaluation becomes much harder to support.

▶️ Watch this week's YouTube video to learn why Scientific Validity matters.
https://youtu.be/Kpk2WG2VW_I

📖 Read this week's blog for a step-by-step explanation and practical examples.
https://patientguard.com/ivdr-scientific-validity/

20/08/2026

Are you prepared for the requirements of the EU IVDR (EU 2017/746)?

Our EU IVDR Training provides a practical overview of the regulation, helping professionals understand the key compliance requirements for in vitro diagnostic medical devices.
The training covers:
✔ IVDR overview
✔ Classification rules
✔ Performance evaluation
✔ Technical documentation
✔ Post-market surveillance and vigilance
✔ Quality Management System expectations
✔ Regulatory responsibilities

Designed for IVD manufacturers, regulatory affairs professionals, quality professionals, importers and distributors, this course equips your team with the knowledge needed to confidently navigate IVDR compliance.

Learn more and book your training:
https://patientguard.com/training-courses/

19/08/2026

World Humanitarian Day

Healthcare technologies play a vital role in humanitarian response, emergency medicine, and improving access to care worldwide.

Healthcare saves lives wherever it's needed most.

This World Humanitarian Day, we recognise the role that safe, compliant medical devices play in supporting healthcare professionals during emergencies, humanitarian missions, and disaster response.

Quality medical technology helps deliver care when every second matters.

Learn more: https://patientguard.com

18/08/2026

MHRA REGULATORY UPDATE: CONSULTATION ON STATUTORY FEES NOW OPEN

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has launched a public consultation on proposed changes to its statutory fees, with the proposed changes due to take effect from 1 April 2027.
For companies placing medical devices and other regulated products on the UK market, this is an important consultation to be aware of.

The proposals include:
🔹 Indexation-only increases for most statutory fees
🔹 Targeted increases for selected higher-value services
🔹 Enhanced service standards and guaranteed timelines for selected services
🔹 Rebate arrangements for certain services
🔹 Enhanced support for eligible SMEs
🔹 Improvements to the MHRA's scientific advice service
🔹 A phased update to the medical devices post-market surveillance fee
🔹 Adjustments to some existing fees

The MHRA says the proposals are intended to support sustainable regulatory delivery while improving the speed, reliability and predictability of its services and supporting a competitive UK life sciences sector.

📅 Consultation period: 17 August – 25 September 2026
📅 Proposed implementation: 1 April 2027

If your organisation is affected by MHRA regulation, now is the time to review the proposed changes and consider whether you should submit a response.

👉 Read the consultation and share your views: https://www.gov.uk/government/consultations/mhra-consultation-on-statutory-fees-2026
At Patient Guard, we help medical device and IVD companies navigate evolving regulatory requirements and stay prepared for changes that can impact their UK and international market access.

Follow Patient Guard for more regulatory updates, guidance and practical insights.

Address

Lancaster House, Amy Johnson Way
Blackpool
FY42RP

Opening Hours

Monday	9am - 5pm
Tuesday	9am - 5pm
Wednesday	9am - 5pm
Thursday	9am - 5pm
Friday	9am - 5pm

Telephone

+441253966900

Website

http://www.patientguard.com/, https://patientguard.com/services/bsi-iso-13485-certificate/

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