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ce mark medical device

I3c Global24 Jan, 2026Business

The CE mark on a medical device indicates that it meets European Union safety, health, and environmental protection requirements. It ensures the product complies with EU regulations and can be marketed across the European Economic Area. This certification is essential for manufacturers aiming to distribute medical devices in Europe.

The Role of UKCA Certification Consultants in the UK

I3c Global22 Jan, 2024Business

The United Kingdom's exit from the European Union brought about a significant shift in the regulatory landscape, especially for manufacturers looking to sell products in the UK market. The UKCA (UK Conformity Assessed) mark became a critical requirement for various products, ensuring they comply with UK regulations. Navigating this complex regulatory environment can be challenging for businesses, which is where UKCA certification consultants come into play. In this blog, we will explore the significance of UKCA certification consultants in the UK and how they assist businesses in achieving and maintaining compliance.

Navigating the UK Market: The Role of Medical Device Consultants

I3c Global28 Dec, 2023Business

The United Kingdom's medical device market is a dynamic and challenging environment, especially in the wake of regulatory changes post-Brexit. For manufacturers looking to introduce or maintain their medical devices in the UK market, understanding and complying with the specific regulations is crucial.

CE Marking Consultant: How They Can Help Your Business

I3c Global25 May, 2023Business

CE marking is a mandatory conformity marking for certain products sold in the European Economic Area (EEA). The CE marking indicates that a product meets the essential requirements of relevant EU Authorised Representative and regulations.CE marking is a mandatory conformity marking for certain products sold in the European Economic Area (EEA).

What is CE Marking? For Medical Devices, It Means A Whole Lot:

I3c Global24 Apr, 2023Business

When it comes to certifying a new device for the European market, there are a number of regulations you'll have to consider. The regulations most directly affecting your device include the Medical Device Directive (MDD),When it comes to certifying a new device for the European market, there are a number of regulations you'll have to consider.

I3CGLOBAL UK Responsible Person Roles & Responsibilities for medical device Registration

I3c Global24 Mar, 2023Business

As a UK Responsible Person for medical device registration, your role is crucial in ensuring that medical devices meet the necessary safety and quality standards before they can be placed on the market. Here are some key points on the roles and responsibilities of a UK Responsible Person for medical device registration:

Guideline Relevance In Pharma Industry

I3c Global24 Feb, 2023Business

Today, Regulatory Affairs is a vibrant business unit that collaborates with an emphasis to get items to the market with readily sensible label in the minimal time as well as costs. Because the enhancing global competition amongst pharmaceutical business, the trick to success depends on getting prompt advertising and marketing approval from the Regulatory Matters of the region where the drug is to be offered. Different federal government companies are involved in managing drugs within their market. Some of them consist of:

UK Responsible person � I3CGLOBAL.UK

I3c Global21 Jan, 2023Business

Currently, the UK participates in the European regulatory network for medical devices, but once the transition period is over, this participation will also end. But what will remain the same and what will change?Currently, the UK participates in the European regulatory network for medical devices, but once the transition period is over, this participation will also end.

UK Responsible Person

I3c Global19 Dec, 2022Business

Medical Device Manufacturers that do not have a physical location in Europe must appoint a European Authorized Representative (EU Representative) who is located within Europe.Visit our website.Medical Device Manufacturers that do not have a physical location in Europe must appoint a European Authorized Representative (EU Representative) who is located within Europe.Visit our website.

CLINICAL EVALUATION OF MEDICAL DEVICE NEW RULES WITH MDR

I3c Global24 Nov, 2022Business

The new EU regulation on medical devices (MDR) has already entered into force. They establish a modern and stronger regulatory framework to protect public health and patient safety. The new rules start to apply after a one-year postponement due to the coronavirus pandemic, addressing the need for greater availability of vitally important medical devices or MDR Clinical Evaluation Report across the EU.