Laser devices cover everything from basic laser pointers to hair removal lasers and laser welding machines. In this guide, we cover European Union compliance requirements for a wide range of laser applications in cosmetic dermatology, medical devices, machinery, and measurements. Continue reading Laser Device Regulations in the European Union: An Overview
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Medical Devices are one of, if not the most, complicated, and tightly regulated products to place on the market within the European Union and the United Kingdom. This is not helped by the change from the Medical Device Directive to the new Medical Device Regulations which come into force in May 2021. This has been further complicated by Brexit as different regulations apply in different areas.
The first step is to identify if the product is actually a Medical Device and then which of the Regulation actually applies. Keep reading, and learn what you must know in this article written by International Associates Limited in the UK. Continue reading Medical Devices EU Authorised Representative & UK Responsible Person Guide
Children’s school supplies and stationary are subject to various safety standards, testing, and labeling requirements in the European Union. In this guide, we explain what importers and manufacturers must know about the Toy Safety Directive, CE marking, REACH, GPSD, EN standards – and other compliance requirements applicable to children’s school supplies and stationary. Continue reading Children’s School Supplies & Stationery Regulations in the European Union
EN standards cover everything from electrical safety and substances, to mechanical toy safety. It’s often necessary that importers and manufacturers carefully study the technical aspects of all relevant EN standards even at the early stages of product development. That said, EN standards are generally not available for free – but must be purchased online.
Further, EN standards can often be purchased both digitally (PDF file) or as a physical hardcopy.
In this guide, we list several online stores where you can buy EN standards covering electronics, toys, textiles, medical devices, machinery, and many other product categories. Continue reading Buying EN Standards Online: A Complete Guide
Planning to import batteries to the EU? In this guide, we introduce what importers and manufacturers should know about the Battery Directive, including restricted substances, labeling requirements, registration process, collection and recycling scheme, and testing companies providing product compliance services. Continue reading Battery Directive Guide for EU Importers: An Overview
Planning or import or manufacture supplements in the European Union? In this guide, we cover the basics of substance restrictions, labeling, notification, documentation, and lab testing requirements for a range of supplements products in the EU.
Supplements are considered as food products in the EU and are mainly regulated by Directive 2002/46/EC – which we cover in more detail in this guide. That said, other regulations may apply if the supplements contain colorants or sweeteners. Continue reading Supplement Regulations in the European Union: An Overview
The Restriction of Hazardous Substances (RoHS) Directive restricts chemicals and heavy metals in electronic products imported to or manufactured in the European Union. Ensuring compliance requires lab testing at some level in the supply chain – be it the final assembled product, individual components, or even raw materials. In many cases, importers opt for a combination of these.
In this guide, we explain what you must know about RoHS lab testing options, costs, substance limitations, compliance risks, Amazon requirements, and more. Continue reading RoHS Product Lab Testing: A Complete Guide
The role of a Notified Body is to assess if a product is technically safe and compliant, correctly documented, and (in some cases) manufactured under the right conditions. In a way, the Notified Body act as a gatekeeper to the EU market – for more ‘high-risk’ and ‘sensitive’ products that cannot be ‘self-certified’.
That said, Notified Bodies are not government organizations. Instead, companies like Intertek and TUV are appointed to act as Notified Bodies for certain product categories.
In this guide, we explain what importers, exporters, and manufacturers must know about Notified Bodies and how they operate. Continue reading Notified Bodies in the European Union: A Complete Guide
Product traceability requirements exist to ensure that products can be traced to a certain importer or manufacturer, production facility, SKU, and even production run. The latter is particularly important as it enables market surveillance authorities (and sellers) to identify and trace unsafe and non-compliant products – and thereby limiting product recalls to faulty batches.
Product traceability labeling is mandatory for a wide range of products, such as electronics, kitchen products, toys, and much more. Still, product traceability is often overlooked by importers and manufacturers.
Keep reading, and learn what importers and manufacturers must learn about different types of product traceability requirements in the European Union. Continue reading Product Traceability Requirements in the European Union: An Overview
EU Importers are responsible to ensure that their wood packaging materials like pallets, skids, containers, cases, and dunnages, and other plant products, are not infested with pests or parasites that could cause ecological damage to the local environment
In this article, we introduce EU regulations and international pest control standards, such as ISPM 15, for wooden products, such as wood packaging materials. Continue reading Fumigation Regulations in the European Union: An Overview
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