The technical documentation is prepared based on the general safety and performance requirements set out in Annex I of the medical device’s regulation. The purpose is to document the product’s characteristics based on an assessment of the product’s quality, safety and performance.

In addition, the documentation must include a …

Clinical Evaluation gadgets comprise an extremely colossal and complex field. Gadgets can go from anything between a thermometer and a pacemaker. The FDA, the US' food and medication administrative body, has a definition for gadgets. It considers a clinical gadget as "an instrument, mechanical assembly, execute, machine, contraption, embed, in…

A blog around the process and requirements of registering a medical device in the UK.

If you're planning on marketing a medical device in the UK, and haven't yet familiarized yourself with the registration process for medical devices, it's time to get started.

As a medical device importer or distributor located in the UK, you will have to comply with all relevant UK product regulations,…

An EU Declaration of Conformity (also known as a Declaration of Conformity or DoC) is a mandatory document that you, as a manufacturer, must produce and sign if you manufacture, import, or distribute products for use in the EU. You must first draw up the technical documentation for the product, which includes, supports, and justifies the DoC

By…

a blog about how you can get recertified for the UKCA and the process.

Before jumping to the process directly, first let us know what is UKCA Marking,

The United Kingdom Conformity Assessment (UKCA Mark) is the UK equivalent of the EU CE Marking. This Mark is a valid indicator that a medical device conforms to relevant UK Regulations. The United kingdom conformity assessment marking is mandatory for medical devices sold in…

The European Authorized Representative is represented on the medical device label with a logo, as seen below. Along with the logo, the EAR name, address, and contact information must be printed on the Declaration of Conformity (DOC), Technical Documentation, and in the Instructions for Use (IFU). To appoint an EU Rep / EC Rep, the manufacturer must sign a contract outlining each…

A blog about ultrasound device identification and guidelines.

Ultrasound device identification (UDI) is an FDA compliance that all medical device manufacturers must adhere to. UDI labels are affixed to medical devices that use ultrasound and is used for tracking purposes in hospitals in case of emergencies.…

How to Know When It is: A blog about clinical trials, the science behind them and how you can get involved.

Clinical trials are studies that involve humans. They are used to test different medical treatments like drugs, vaccines, or medical devices. Find out more about clinical evaluation, the science behind it and how you can get involved.…

The activity of your company will determine if you should apply to join the registry.

Once you have been registered in it, you must keep the health authorities up to date on any change in the ownership and physical address of your company, in the characteristics of your products and in the manufacturing processes.

You must also notify them when you discontinue the…

The technical file is a collection of information and documents that describe in detail the medical device under consideration and in particular the aspects related to the safety and efficacy of the product, starting from the design phase up to post-marketing surveillance.…

I3CGLOBAL Group help food, alcohol, dietary supplement, cosmetic, and medical device companies comply with FDA requirements and regulations. The main purposes of "pre-compliance" assistance are to ensure that your product is marketable in the United States, before entry, and to avoid timely and costly delays.

Pre-compliance assistance includes product and label review, US agent services for the registration of foreign food…

This new regulation will affect all companies that sell CE-marked products manufactured outside the European Union. 

As the Brexit transition period is over, this includes UK-made products, but also e-commerce and e-business companies like Amazon. Therefore, resellers of CE-marked…

Once the Brexit transition period ends, organizations based in the UK trade with the European Union will be required to appoint an European Authorized Representative.

What is an EU representative? 

A legal entity established in the EU serves as a point of contact between your…

Every month, there are a lot of new medical devices which are submitted for the marketing approval from the FDA. One of them is the CE Marking approval which shows out the one device which will show the audience that it is purely legal and it is authorized for being a medical device. Most of these devices are firstly turned down or they are also re classified some of the times, but hundreds and thousands of them ended up in getting the approval…

The European Conformity Marking (CE) is the procedure by which a manufacturer (or importer) reports that the product to be marketed in the European Union meets the essential health and safety requirements defined in the mandatory legislation.

It is one of the basic pillars of the European Union for the free movement of goods, which helps to create an Internal Market favorable to development and wealth creation.…