April 2024 – News Letter

As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy. We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information.
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Message from our Founder

Dear Valued Clients and Partners,

As we step into the spring of 2024, we are delighted to present the latest edition of Patient Guard’s Newsletter, dedicated to providing you with insightful updates and invaluable resources in medical device and In Vitro Diagnostics (IVD) regulatory affairs and quality assurance consultancy.

We have been busy updating our website to change it from a generic consultancy website to an informative resource for medical device and IVD information. We also attended the Medical Technology Exhibition in Coventry in March, where we met lots of people with new and interesting medical device ideas they are developing.

We will be attending the Medtech Exhibition at Birmingham NEC arena in June 2024.

We wish you a lovely April and look forward to engaging with you soon.

Best wishes

David Small – Founder of Patient Guard

Image of our founder David Small he is the CEO of Patient Guard Group

Regulatory News

EU

UK

UK

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Important Deadline - 26th May 2024

If you currently sell CE marked legacy devices under MDD in the EU or the UK which requires a Notified Body under MDR, then you must have a contract in place with a Notified Body for MDR to take advantage of the certificate extensions under article 120 to allow you to continue to place your devices on the market under MDD until 2027/2028.

CE marked devices under MDD in the UK which require a Notified Body must upload their extension certificates on the MHRA portal to remain compliant.

This does not apply to UKCA marked devices or devices that do not require a Notified Body under CE marking.

New medical devices are required to follow MDR for CE marking.

red caution symbol used to explain medical device risk management in line with ISO 14971 on Patient Guards medical device consultancy risk management blog.

Updated MDCG Guidlines

  • MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

MDCG
Image with the words New MDGC guidance written in Blue text.

Updated MHRA Guidelines

  • Notify the MHRA about a clinical investigation for a medical device

MHRA
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New/updated Standards issued

  • ISO 17665:2024 – Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices

  • IEC 80601-2-58:2024 – Medical electrical equipment. – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

  • ISO 18562-4:2024 – Biocompatibility evaluation of breathing gas pathways in healthcare applications – Tests for leachables in condensate

  • BS EN ISO 20916:2024 – In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice

  • BS EN IEC 80601-2-26:2020+A1:2024 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of electroencephalographs

  • BS ISO 5832-11:2024 – TC – Implants for surgery. Metallic materials – Wrought titanium 6-aluminium 7-niobium alloy

Patient Guards latest news letters detailing all the latest medical device and IVD regulatory updates and standards updates.

Our Latest Videos

Understanding Personal Protective Equipment (PPE) Regulations in the EU is essential for ensuring the safety, quality, and compliance of PPE products. In this video, Patient Guard breaks down the key regulations governing PPE in the European Union, highlighting how these standards safeguard workers and the public from hazards. Learn about the conformity requirements, certification processes, and quality checks that manufacturers must adhere to for their PPE to be deemed safe and effective. Stay informed on how PPE regulations protect lives, enhance product reliability, and support workplace safety. Subscribe for more insights on medical device compliance and safety standards. Read this blog here: https://patientguard.com/personal-protective-equipment-ppe-regulations/ #PPEregulationsEU #personalprotectiveequipmentcompliance #PPEsafetystandards #EUconformity #PatientGuard #PPEcertification For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/
EU Authorised Representative PPE | Patient Guard
Cosmetics regulations play a crucial role in ensuring the safety, quality, and effectiveness of the products we use on our skin, hair, and body. These regulations help protect consumers by preventing harmful ingredients, reducing health risks, and promoting accurate labeling and product claims. Stay informed about how these guidelines safeguard your wellbeing! EU Representative. #CosmeticSafety #ConsumerProtection #ProductRegulations #SafeCosmetics #PatientGuard Click for Blog page here: https://patientguard.com/cosmetics-regulations/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/
EU Representative for Cosmetics | Patient Guard
EU Authorised Representative The EU Authorised Representative role for medical devices has existing since before the introduction of the Medical Device and In Vitro Diagnostic Regulations (EU MDR 2017/745 and EU IVDR 2017/746) were introduced in 2017 and was a requirement of their predecessors the medical device directives. Since the MDR and IVDR Regulations were introduced the role of the EU Authorised Representative has become wider in scope and responsibilities. Read Blog here: https://patientguard.com/authorised-representative-mdr-ivdr/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/ #EUAuthorisedRepresentative #patientguard #medicaldevices #medicaldevicecompliance #medical #patientsafetyfirst #EUmedicaldevice
EU Authorised Representative | Patient Guard
In this informative video from Patient Guard, we dive deep into the essential regulations surrounding Personal Protective Equipment (PPE). Discover how these regulations are designed to ensure the safety, quality, and efficacy of PPE, protecting individuals from various hazards in the workplace and beyond. - What PPE regulations are and why they matter - Key standards that govern PPE safety and quality - How to choose PPE that conforms to these regulations - The importance of compliance for both employers and employees - Stay informed and ensure you’re using PPE that is fit for purpose. Don't forget to like, subscribe, and hit the notification bell for more insightful content on safety and compliance! Click here for this blog: https://patientguard.com/personal-protective-equipment-ppe-regulations/ #patientguard #PersonalProtectiveEquipment #SafetyRegulations #WorkplaceSafety #HealthAndSafety #ProtectiveGear #Compliance #PatientGuard #SafetyStandards #PPERegulations #WorkplaceHazards #Efficacy #QualityControl #SafetyFirst #HealthAndWellness For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/
Personal Protective Equipment (PPE) Regulations | Patient Guard
UK Rep Cosmetics, we dive into the critical role of cosmetics regulations in the UK. Discover how these guidelines are designed to protect consumers by ensuring the safety, quality, and efficacy of products used on the skin, hair, and body. We’ll explore the importance of preventing harmful ingredients, safeguarding against health risks, and ensuring that all products are accurately labeled with truthful claims. Whether you’re a beauty enthusiast or simply curious about what goes into your favorite cosmetics, this video is a must-watch! Don’t forget to like, subscribe, and hit the notification bell for more insights into consumer safety and health regulations. View this blog: https://patientguard.com/cosmetics-regulations/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/ #PatientGuard #CosmeticsRegulations #ConsumerSafety #UKBeauty #HealthySkin #Skincare #BeautyCommunity #CosmeticsSafety #InformedBeauty #HealthyCosmetics #SkincareEducation
UKRP for Cosmetics | Patient guard
The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person. The UKRP acts on behalf of the non-UK manufacturer to carry out specified tasks in relation to the manufacturer’s obligations. As noted above, this includes registering the manufacturer’s devices with the MHRA before the devices can be placed on the UK market. Read this specific Blog post here: https://patientguard.com/uk-responsible-person-medical-devices/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/ #patientguard #UKRP #UKResponsiblePerson #PatientSafety #UK #MedivalDeviceComplaince #MHRA
UK Responsible Person (UKRP) – Medical Devices | Patient Guard
The Biological Evaluation of Medical Devices In healthcare, ensuring the safety and efficacy of medical devices is paramount. Patients rely on these devices for diagnosis, treatment, and improved quality of life. Biological evaluation plays a pivotal role in determining the biological safety of these devices. Governed by international standards, most notably the ISO 10993 series, biological evaluation involves a thorough assessment of a device's interaction with living tissues. This blog delves into the importance of biological evaluation, highlighting the critical biological endpoints outlined in ISO 10993, the significance of a robust biological evaluation plan, and the crucial role of qualified experts in this process. #patientguard #patientsafety #patientsafetyfirst #BiologicalEvaluation #medicaldevices #medicaldevicecompliance Read this specific Blog post here: https://patientguard.com/biological-evaluation-medical-devices/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd?mx=2 - Instagram: https://www.instagram.com/patientguard2017/
The Biological Evaluation of Medical Devices | Patient Guard
In the highly regulated world of medical devices, ensuring patient safety is paramount. One of the essential components of this safety assurance is cytotoxicity testing, specifically adhering to ISO 10993-5 standards. This blog explores the importance of ISO 10993-5 cytotoxicity testing, particularly for medical devices that come into direct contact with patients, and how it contributes to the overall safety and efficacy of these devices. #CytotoxicityTesting #PatientGuard #ISO10993-5 #MedicalDeviceSafety #HealthcareCompliance #ProductSafety Read this specific Blog post here: https://patientguard.com/cytotoxicity-testing-in-medical-device-biological-evaluation/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd - Instagram: https://www.instagram.com/patientguard2017/
Understanding Cytotoxicity Testing | Patient Guard
At Patient Guard, we understand the critical importance of ensuring the safety of medical devices. In this video, we focus on In Vitro Skin Irritation Testing and the ISO 10993-23 Standard. Skin irritation is a significant concern for medical devices that come into direct and prolonged contact with the skin. Without proper testing, products could cause anything from minor redness to severe dermatitis, leading to serious health risks. This video breaks down how in vitro testing methods offer a reliable and ethical solution to assess skin irritation, ensuring that your medical devices meet the stringent requirements of the ISO 10993-23 Standard before they reach the market. By following these guidelines, you protect both your patients and your brand. #PatientGuard #SkinIrritationTesting #ISO1099323 #MedicalDeviceSafety #InVitroTesting #HealthcareCompliance #ProductSafety Read this specific Blog post here: https://patientguard.com/in-vitro-skin-irritation-testing-iso-10993-23-standard/ For more information, visit our official website: 🌐 www.patientguard.com Looking for Quality Assurance Templates to enhance your Quality Management System? Check out: 🌐 www.qmsregs.com 🔔 Subscribe: Subscribe to Patient Guard for more insights, Subscribe Here: / @patientguardlimited6362 Connect and follow us on: - LinkedIn: https://www.linkedin.com/company/patient-guard-ltd/ - Facebook: https://www.facebook.com/profile.php?id=100090284016494 - X: https://x.com/patientguardltd - Instagram: https://www.instagram.com/patientguard2017/
In Vitro Skin Irritation Testing: ISO 10993-23 Standard | Patient Guard
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