Patient Guard

April 2024 – News Letter

Hello April, spring related motivational quote, isolated on white background, vector illustration. Handwritten letters, Japanese sakura branch, little cute flowers falling. Used by Patient Guard Medical Device and IVD Regulatory and Quality Assurance consultancy agency for their April news letter.

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

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.

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

Updated MDCG Guidlines

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

Updated MHRA Guidelines

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

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

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

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