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.
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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
Before a cosmetic product is placed in the EU market, a safety assessment of the cosmetic product must be conducted and a cosmetic product safety report drafted.
Some cosmetics testing companies can help in performing the necessary testing to verify that your product doesn’t contain banned substances – and compiling the documents needed to create the cosmetic product safety report.
In this article, we list companies that claim to have lab testing facilities in the EU and provide testing services for cosmetic products according to the provisions in the Cosmetic Products Regulation.
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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.
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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.
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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
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Article 4 and 5 of the Market Surveillance Regulation (EU) 2019/1020 requires that companies established outside the EU, but selling certain products to consumers in the single market, must have an authorised representative – in particular products that require CE marking.
In practice, this means that non-EU companies pay EU entities to act as their authorised representative. Further, the packaging must also include the name and address of the authorised representative.
In this guide, we explain how this works in practice, and what the consequences can be if you don’t have an authorised representative.
Related Articles
1. This guide only covers EU AR requirements within the scope of the Market Surveillance Regulation (EU) 2019/1020. If you are looking for authorised representative requirements concerning medical devices, then you can find the relevant article here.
2. This guide covers authorised representative requirements in the UK.
Continue reading European Union Authorised Representatives: A Complete Guide
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