UK Regulations Archives

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.

April 2024 – News Letter

EU Regulations, Guides and Advice, Patient Guard News, Standards, UK Regulations, USA Regulations / David Small

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.

April 2024 – News Letter Read More »

A certificate that says 'ISO 13485 certified' on it - This image is used by patient guard to represent ISO 13485 quality assurance and QMS services.

What is ISO 13485?

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, Medical Device Validation, Quality Assurance, Quality Management, Standards, UK Regulations, USA Regulations / David Small

ISO 13485 is an international standard for mapping what is required from a medical device. The system ensures that medical devices are effective and consistent throughout their life cycle, from planning and production to disposal.

Ensuring consistency is extremely important for medical devices, as patient safety could be at risk. Implementing quality management systems can also provide protection for manufacturers and their reputations, as risks can be easily identified and rectified.

Medical device regulation varies based on the classification of the medical device being manufactured. All parties are required to demonstrate compliance, from the medical device manufacturing process to the disposal of the product.

What is ISO 13485? Read More »

global medical device and IVD registrations.

Medical Device & IVD registration

Blog, EU Regulations, UK Regulations, USA Regulations / David Small

Medical device registration is an essential part of commercialising your medical device or IVD. First requires you to obtain registration and approval from regulatory agencies in each country where you plan to sell your device. Device registration requirements can vary significantly from country to country, which can create compliance challenges for companies pursuing multiple-market strategies.

Medical Device & IVD registration Read More »

Image of a file with a cog and lines above it representing text. The cog represents technical information. The image is used by patient guard limited to discuss medical device technical files (EU 2017/745).

How to Structure a Medical Device Technical File

Blog, EU Regulations, Guides and Advice, Medical Device Pre-launch, UK Regulations / David Small

A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and safety of a particular Medical Device in a clear, well-organized, easily searchable, and unambiguous manner.

In order to prove compliance with the general safety and performance criteria of the legislation, the manufacturer must have – and keep up-to-date – this technical documentation, regardless of medical device class.

How to Structure a Medical Device Technical File Read More »

Medical Device Start-up

Blog, EU Regulations, Guides and Advice, Medical Device Post-launch, Medical Device Pre-launch, UK Regulations, USA Regulations / David Small

Starting a medical device company can be a stressful time, what with design and development activities, finding funding, ensuring you don’t run out of capital etc.

One very important area that is often not considered early enough is the regulatory side. Many medical device startup companies think that the regulatory activities don’t begin until the device has been developed and they often don’t realise the cost involved in ensuring that the medical device meets the safety requirements of the medical device regulations globally

Medical Device Start-up Read More »

Image shows a Doctor in green scrubs with folded arms - This image is used by Patient Guard to describe its medical device and IVD regulatory and quality assurance related content.

What is the importance of medical device registration?

Blog, Client Questions, EU Regulations, UK Regulations, USA Regulations / David Small

The main reason medical device registration is so important is safety. Ensuring that devices meet medical device regulations means that everyone involved can be confident that they are safe for their intended use. All medical devices are extremely important and can have life-saving capabilities. This means that devices must be working to their full potential.

What is the importance of medical device registration? Read More »

Regulating medical devices in the UK

Blog, UK Regulations / David Small

Regulating Medical Devices in the UK is slightly different to other countries. When manufacturing medical devices for the UK market, you must be registered with the MHRA. They can help to ensure that your device meets safety guidelines and issue you with advice should you need it.

Regulating medical devices in the UK Read More »

Medical Devices Classification - This is an illustration of two contact lenses. This image is used by patient guard to represent an example of class IIa medical devices.

Medical Devices Classification UK

Blog, UK Regulations / David Small

In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring), Class IIa, Class IIb and Class III.

Class I devices are considered to be of low risk, Class II devices as medium risk and Class III devices as high risk.

Depending on the classification of device determines the regulatory conformity pathway that needs to be taken to gain compliance and allow manufacturers to place product on the UK market.

Medical Devices Classification UK Read More »

UK Regulations

April 2024 – News Letter

What is ISO 13485?

Medical Device & IVD registration

How to Structure a Medical Device Technical File

Medical Device Start-up

What is the importance of medical device registration?

Regulating medical devices in the UK

Medical Devices Classification UK

UK Office

German Office

Quick Links

Get the Medical Device Technical Checklist

Get the Medical Device Technical Checklist

Speak to one of our medical device consultants

Get the latest updates on medical device regulation

We can help you!