February 2024 – News Letter

As we step into the month of February, we at Patient Guard are delighted to extend our warmest greetings to you. We hope this newsletter finds you well and thriving in your respective endeavors. As always, we are committed to keeping you informed about the latest developments in the ever-evolving landscape of medical device regulatory affairs and quality assurance.
the word february with red, pink and white heats exploading like confetti around it - This image is used for Patient Guards February news letter.
Facebook
X
LinkedIn
the word february with red, pink and white heats exploading like confetti around it - This image is used for Patient Guards February news letter.

As we step into the month of February, we at Patient Guard are delighted to extend our warmest greetings to you. We hope this newsletter finds you well and thriving in your respective endeavors. As always, we are committed to keeping you informed about the latest developments in the ever-evolving landscape of medical device regulatory affairs and quality assurance.

In recent months, we’ve witnessed several significant regulatory updates across various regions. Notably, the FDA’s continued efforts to streamline the regulatory process for medical devices have been commendable. We are closely monitoring the implementation of the FDA’s latest guidance documents and initiatives, ensuring our clients remain compliant and well-informed.

Additionally, the European Union’s Medical Device Regulation (MDR) continues to be a focal point for manufacturers and regulatory professionals alike. With the deadline to have a contract in place with a Notified Body fastly approaching, compliance with the MDR standards is paramount. Our team is dedicated to guiding our clients through this process seamlessly, providing expert advice and support every step of the way.

Picture of lots of paper cut out hears in all different rainbow colours - used by patient guard for their february news letter - medical device regulatory affairs and quality assurance consultanct services

Maintaining the highest standards of quality is fundamental to the success and reputation of any medical device manufacturer. At Patient Guard, we are committed to assisting our clients in achieving and surpassing these standards. Our comprehensive quality assurance services encompass everything from risk management and quality system implementation to post-market surveillance and audits.

As technology advances and consumer expectations evolve, staying ahead of the curve is imperative. Our team continuously evaluates emerging trends and best practices in quality assurance to ensure our clients remain at the forefront of innovation while adhering to rigorous quality standards.

Latest Medical Device Regulatory News

Latest EU MDCG Guidance Updates

  • MDCG 2024-1 – Device Specific Vigilance Guidence (DSVG) Template

  • MDCG 2024-1-1 – DSVG on Cardiac ablation

  • MDCG 2024-1-2 – DSVG on Coronary stents

  • MDCG 2024-1-3 – DSVG on Cardiac implantable electronic devices (CIEDs)

  • MDCG 2024-1-4 – DSVG on Breast implants

 

Latest Medical Device Standards issued

  • BS EN IEC 60601-2-21:2021+A1:2023 – Medical Electrical Equipment – Particular Requirements for the basic safety and essential performance of infant radiant warmers

  • ISO 11979-7:2024 – Ophthalmic implants. Intraocular lenses – Clinical investigations of intraocular lenses for the correction of aphakia

  • BS EN IEC 80601-2-77:2021+A1:2023  – Medical electrical equipment – Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

  • BS ISO 10555-7:2023 – Intravascular catheters. Sterile and single-use catheters – Peripherally inserted central catheters

  • BS EN ISO 17664-2:2023 – Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices – Non-critical medical devices

  • BS EN IEC 60601-2-19:2021+A1:2023 – Medical electrical equipment – Particular requirements for the basic safety and essential performance of infant incubators

Most Popular

Medical Device Cleaning Validation

Cleaning validation is a critical process for ensuring the safety and effectiveness of medical devices by verifying that they are free from harmful contaminants such as biological residues, chemical remnants, and particulate matter. This process is essential for meeting stringent regulatory standards, including ISO 13485, ISO 14971, EU MDR, and FDA guidelines, which mandate thorough cleaning protocols to mitigate risks to patients and device functionality. By defining acceptance criteria, conducting risk assessments, and performing robust validation testing, manufacturers can establish consistent cleaning processes that meet compliance requirements.

Read More »

Medical Device Labelling

Medical Device labelling is a key requirement of regulations world wide. Manufacturers of medical devices are required to ensure that the products they place on the market are appropriately labelled, this enables traceability, and key information to users on how to use the devices safely.

Read More »

Notified Bodies

Notified Bodies are essential for ensuring product safety and compliance. Whether your business operates in the European Union (EU) or the United Kingdom (UK), understanding how to work with these organizations is vital. This blog explains the role of Notified Bodies, their importance under EU and UK regulations, and what manufacturers need to know.

Read More »

Understanding EU MDR GSPRs

The General Safety and Performance Requirements (GSPRs) are detailed in the EU Medical Device Regulations (MDR) EU 2017/745 and detail what a manufacturer must show to prove that the medical devices they sell are safe and perform as intended.

Read More »
patient guard
Patient Guard

Sign up to our newsletter

Be the first to hear industry news and how Patient Guard can help you.

Get the Medical Device Technical Checklist

Thank you! The checklist is now ready to download.

Get the Medical Device Technical Checklist

Complete the form below and receive instant access.

Speak to one of our medical device consultants

For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.

UK Office

Get the latest updates on medical device regulation

Sign up to our newsletter and we’ll deliver news and insights straight to your inbox.

Patient Guard Regulatory Affairs and Quality Assurance

Do you need support with Medical Device or IVD compliance?

We can help you!