Registration and Notification Services
Some EU and UK Regulations require the registration, or ‘Notification’, of products that fall within their scope. The regulations covering medical devices in particular, require manufacturers to complete detailed and time-consuming registration processes before they can legally place their products on the market in either the EU or the UK.
In many cases Registration or Notification can only be completed by parties who are legally established in the territory where the product is to be sold. For Manufacturers located outside of either the EU or UK, or both, this is where having an experienced Authorised Representative or Responsible Person like Eurolink Europe can be of even greater value.
With thirty years of experience and the necessary approvals to allow access to key government platforms, Eurolink Europe can provide active assistance to ensure products are correctly registered or notified. We can also manage those registrations and notifications on an ongoing basis.
Do I Need to Register my Product?
Whether a manufacturer needs to get their products registered or notified will depend on which EU or UK regulations are applicable to them. The following regulations currently require some form of Registration or Notification:
European Union:
- Medical Devices Regulation (EU) 2017/745
- In Vitro Diagnostic Devices Regulation (EU) 2017/746
- Cosmetic Products Regulation (EU) 1223/2009
- The Outdoor Noise Directive 2000/14/EC
- Energy Labelling Regulation (EU) 2017/1369
United Kingdom:
- The Medical Devices Regulations 2002
- The Regulation (EC) No 1223/2009 on Cosmetic Products
What is the Process for Registering or Notifying Products?
The registration or notification process varies between different regulations. Some require uploading of product information and evidence of conformity to databases via online portals. Others also require registration of manufacturers, importers and other actors in the supply chain, as well individual product details.
For some regulations registration and notification is a relatively straightforward process that can be completed quickly and simply if the necessary information is available for submission. In other cases, it can be a lengthy process, with multiple stages that need to be carefully managed.
In some cases, such as with Cosmetics Regulations, the simplicity of the notification process allows Eurolink to handle it from start to finish on behalf of our clients. By comparison the process for registering Medical Devices in both the EU and the UK requires the active involvement of both Eurolink and the manufacturers we represent.
Eurolink Product Registration and Notification Services include:
- Providing advice on the registration requirements for different products, including Medical Devices and Cosmetics
- Providing Clients with access, when necessary, to registration portals
- Registering Clients and their products with EU, UK and other national competent authorities
- Payment of registration fees on behalf of our Clients
- Maintaining compliance records in line with product development
- Informing Clients of changes to legislation and registration requirements
Please be aware that these services are only available to clients for whom Eurolink acts as an Authorised Representative or Responsible Person in the EU and/or UK.
• Over 30 years experience.
• Single service provider for both the EU and UK markets.
• Extensive portfolio of customers across multiple industries and sectors.
• Thousand of products represented.
• Expert knowledge on the regulatory compliance industry.
• Competitive fees and customer focused service.
• Flexible and highly responsive.
• We will always find time to understand and guide you through any challenges you may have.
• We are able to provide advice and guidance or interact directly with Regulatory Authorities on your behalf.
