Products covered by the Medical Devices Regulation are required to be accompanied by labelling information, such as CE marking, traceability information, notified body information, and instructions.
This guide serves as an introduction to labelling requirements in the context of the Medical Devices Regulation.
Continue reading Medical Devices Labelling Requirements in the European Union
Certain products covered by the Medical Devices Regulation (MDR) require the involvement of a notified body before being placed in the EU market. The extent of the involvement of the notified body is determined based on the classification of the medical device.
In this guide, we explain in which case a notified body should be approached. Additionally, we provide a list of various notified bodies in the EU for medical devices and explain how you can search for a notified body in other EU member states.
Methodology
The list of EU-notified bodies that we provide is retrieved from the notified bodies (NANDO) database. Note that we only provide examples of notified bodies for some countries, not a definitive list.
Continue reading EU Notified Bodies for Medical Devices: An Overview
All cosmetic products must be subject to a safety assessment before being sold in EU markets. A key document that is produced during this stage is the Cosmetic Product Safety Report (CPSR) which is required to ultimately place the product in the market.
In this guide, we address common questions concerning the CPSR, unveil the individuals and businesses that are necessarily involved with its production, and provide a list of companies that provide related services.
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The key role when placing cosmetic products in EU markets is that of the responsible person. Without the responsible person assigned to the cosmetic product, it would not be possible to legally sell it within the EU.
In this guide, we address common questions associated with this role and explain what importers and manufacturers must know about the duties of the responsible person.
Continue reading Responsible Person for Cosmetic Products in the EU
The Cosmetic Products Regulation states that the responsible person (e.g., the manufacturer or importer) must use the Cosmetic Products Notification Portal (CPNP) to notify the EU regarding their cosmetic products, as well as nanomaterials used in cosmetic products.
In this guide, we explain the notification requirements as described in the Cosmetic Products Regulation.
Continue reading Cosmetic Notification Requirements in the European Union
Cosmetic products sold in the European Union must be labelled according to the provisions of the Cosmetic Products Regulation. Cosmetic labels must, for example, contain information about the company selling the product, content, batch number, and intended use.
Thera are also restrictions concerning product claims, and requirement related to precautions and warnings.
Further, we also cover labelling requirements that are part of regulations other than the Cosmetic Products Regulation, but that are still applicable to cosmetic products.
Continue reading Cosmetic Products Labelling Requirements in the European Union
Various types of labelling requirements apply to essentially all products manufactured or imported for sales in the European Union. These are normally part of regulations and directives, such as the Low Voltage Directive or General Product Safety Regulation.
EU labelling requirements cover compliance symbols, such as the CE mark and WEEE mark, traceability, and more.
Failing to correctly label the product and packaging can result in fines or a recall – which is why it’s so important to understand the requirements that cover your products.
Note that this guide doesn’t cover packaging recycling symbols, which can be found here.
Continue reading European Union Product Labelling Requirements: A Complete Guide
Microplastics are particles that are smaller than 5 mm and made of polymers and additives. These can be found in products such as cosmetics, personal care products, and cleaning products.
Microplastics can get released into the environment, harming it. As such, the EU now restricts microplastics and products and mixtures that contain intentionally added microplastics.
In this guide, we explain what importers and manufacturers should know about microplastics, including which products may contain them, whether these are banned, and how the REACH and EU Ecolabel Regulations restrict microplastics.
Continue reading Microplastic Regulations in the European Union: An Overview
Extended Producer Responsibility (PRO) is covered by provisions of the European Packaging and Packaging Waste Directive 94/62/EC. In practice, EPR requires producers (which includes brands, importers, or manufacturers) to finance packaging waste collection.
This is managed on a national level, by approved organisations. In France, Léko is one such Producer Responsibility Organisation (PRO).
In this guide, they share what businesses selling products in France must know about the EPR registration process, fees, Triman, and other packaging waste instructions.
Continue reading Extended Producer Responsibility in France – Q&A with Léko
A broad range of products can contain Bisphenol A (BPA), which is used to enhance plastic durability. However, Bisphenol A (BPA) is restricted under various regulations in the EU due to its potential to cause harm to human health.
More specifically, Bisphenol A is restricted in consumer products, food contact materials, and toys in the European Union.
In this guide, we explain how regulations REACH, the Toy Safety Directive, and other regulations, including some national laws, either restrict or relate to Bisphenol A.
Continue reading Bisphenol A (BPA) Regulations in the European Union: An Overview
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