clinical evaluation

When a company based outside of the United Kingdom (UK) wants to sell its medical device products in the UK, it is required to appoint a UK Responsible Person (UKRP) who will act as a liaison between the manufacturer and the Medicines and Healthcare products Regulatory Agency (MHRA).  Here are some key points to keep in mind regarding MHRA UK Responsible Person Services: What is a UK Responsible Person? A UK Responsible Person (UKRP) is a legal entity appointed by a non-UK manufacturer to act as its representative in the UK. The UKRP is responsible for ensuring that the manufacturer's medical devices comply with UK regulations. What are the responsibilities of a UK Responsible Person? The responsibilities of a UK Responsible Person include registering the manufacturer's medical devices with the MHRA and ensuring that the devices are properly labeled, marketed, and distributed in the UK according to the regulations. The UKRP also serves as a liaison between the MHRA and the ma...

A blog about the benefits of obtaining a FDA approval and how you can obtain one. The FDA stands for the Food and Drug Administration, it is an agency of the United States Department of Health that is tasked with protecting and promoting public health. Failing to obtain FDA approval for your product, is illegal. This blog post will explain in detail why you need a FDA approval. FDA Approval is an Assurance If you are a manufacturer or a Medical Device CE Marking , obtaining FDA approval is a must. It ensures that your product meets the standards of quality and safety imposed by the government agency. Furthermore, it provides an assurance to your customers that the product is safe for use. The process of obtaining FDA approval involves several steps which include: Determining if your product meets all the requirements for approval. Providing sufficient data on the safety and efficacy of your medical device. Informing about any risks associated with using your product. FDA Approval ...

The CE marking is a significant indicator that the product complies with European legislation and allows the free movement of products within the European market. When a manufacturer affixes the CE marking to a product, he declares, under his sole responsibility, compliance with all the legal requirements necessary to affix the Medical Device CE Marking , and thus gives rise to the product being able to be sold in the space European economy, Switzerland and Turkey. This also applies to products made in third countries that are sold in the European Economic Area (EEA), Switzerland and Turkey. The CE marking does not indicate that the product has been manufactured in the EEA, but rather that the product is evaluated before being placed on the market and meets the Union's safety, health and environmental protection requirements.  This means that the manufacturer verifies that the product meets all the essential requirements of the Directives that apply to it or, if stipulated in the D...

Due to the increasingly common presence of imported medical devices in the European Union, the figure of the Authorized Representative (EC REP, European Authorized Representative) is becoming more common. This figure must guarantee compliance with current regulations on medical devices for medical devices manufactured outside the European Union.  Regulation 2017/745 of medical devices establishes the obligation for all manufacturers of medical devices established outside the European Union to have a permanent authorized representative who serves as an interlocutor for the European health authorities and has a documentary file with technical information. of medical devices (Technical file among others). The authorized representative must be a natural or legal person based in an EU member state and appear on the labels of Medical Device CE Marking for sale in the EU.  The appointment of this EC REP must be in writing along with its acceptance and in the case of class I products...

I3CGLOBAL makes the EUROPEAN AUTHORIZED REPRESENTATIVE service for medical devices available to its non-EU customers. All medical devices (including active and in vitro) manufactured outside the European Union must have an authorized representative in the European Union based in any member state who must be appointed by the medical device manufacturing company in writing. This representative must carry out the obligations contained in the European regulations on medical devices, Directive 93/42/EEC on medical devices and Regulation 2017/745 on medical devices. The EU authorized representative must be communicated to the authorities at the time of notification of placing on the market of class IIa, IIb and III medical devices. This company responsible for medical devices marketed in the European Union must act as an interlocutor for the community health authorities and have at their disposal all the information related to imported medical devices at the headquarters communicated in a me...

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?  The answers to these questions are below. All devices that comply with the applicable EU Directive will continue to be allowed until June 2023 Changes to the labeling of the affected products will not be required. Labels in English that include information from other jurisdictions will be accepted.  The product can still carry a CE mark and devices that require conformity assessment by a notified body must have a valid CE certificate. On the day of departure, a UK regulatory system will be available. All the key elements that are included in the EU regulations will appear in it.  MDR and IVDR will not be "active" in the UK, but both regulations will be accepted until the end of June 2023.  A change in the role of notified bodies will be implemented A...

A blog about why your CE mark is important and what it means. CE Marking is not a new concept. In fact, it has been around for almost 50 years, and it's been made more important than ever with the surge in global manufacturing. Whether you are selling products in the EU or creating products for use within the 28 Member States of the European Union, your products must comply with all relevant  FDA Registration . CE marking, often marked with a CE logo, is a safety mark to alert consumers their products are made in the European Union and meet regulations. The regulation can be one of three: the Low Voltage Directive (LVD), the EMC Directive (EMC), or the R&TTE Directive (Radio & Telecommunications Terminal Equipment). CE marking was introduced as a replacement for national marks in order to allow sector wide coordination of laws and regulations. What is CE marking? CE marking is a mandatory requirement for all products placed on the European market. CE marking means that the ...