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
Regulatory News
EU
UK
FDA
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.
Updated MDCG Guidelines
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
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
