The responsibilities of manufacturers that are based within the EU are straightforward, but for manufacturers based outside of the EU who sell on the EU market, it can be difficult to know which economic operator within their supply chain is responsible for what. In such cases, an Authorised Representative (AR) will play a part in […]
A Complete Guide to Medical Device Certification and Compliance in the European Union and the United Kingdom
In the European Union and the United Kingdom, there are specific regulatory and legal perimeters that apply to the manufacturing and distribution of medical devices. We have developed this comprehensive guide to assist manufacturers who are either based in these regions or who plan to sell their medical device products on either of these markets.
In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices. Since January 2021, there have been a number of changes when it comes to regulating medical products in the UK, and this article is intended to provide an easy-to-follow guide for ensuring your product meets the correct requirements.
Medical devices cover a wide range of products – from robot-assisted surgical instruments to a bandage or gauze. The spectrum of medical device classification is wide and it is extremely important to know which classification your product falls under. In the United States, there are both mandatory and voluntary certification procedures when it comes to ensuring compliance with your medical device. We have outlined the key requirements for your business here.
The world of electronics is constantly evolving. It seems that increasingly, everyday household items are beginning to integrate automation, robotic components, or artificial intelligence. It’s an incredible thing, to say the least, and exciting for the future of society and the people living in it. There are, however, a number of considerations that need to be taken when placing electronics products onto any market, in order to ensure the safety, sustainability, and longevity of the product.
The Machinery Directive (also known as Directive (EU) 2006/42/EC) exists to establish a regulatory framework for placing machinery on the Single Market of the European Union. During the ‘REFIT’ evaluation of the Directive, stakeholders confirmed that this legislation, while important, contains a necessity to improve and adapt to the needs of the market. The revision was listed in the European Commission’s 2020 Work Programme.
There are multiple ways to ensure the safety of electrical equipment. Due to regulatory changes such as the RoHS III and the introduction of the new International Electrotechnical Commission (IEC) standard 62368-1, questions often arise when choosing a compliance route for electrical products. Here’s what you should know about CE marking and CB certification of electrical equipment.
Robotics is a complex topic that requires the finest attention to detail in terms of ensuring compliance standards are met in any market. The European Commission has developed standards specifically relating to different types of robots, and it is important that manufacturers ensure they are meeting the correct standards for the type of robot they wish to put onto the market. We have simplified some of the information for you in this article.
New European Union regulations for market surveillance will affect the responsibilities of actors throughout EU product supply chains. This article outlines the responsibilities of the manufacturer, importer, distributor, fulfillment service provider and Authorised Representative for products sold in the EU.