There are many things to consider when introducing a product to the European Market for the first time. Right at the top of that list is: What is the background of my third-party producer and are there any barriers to their components entering the market?
As always, there are some steps that must be taken into consideration, especially when the manufacturers in question are themselves not located inside the European Union. In this blog, we will outline and answer some of the most pressing questions when it comes to third-party producers and the European Market.
Do I need to appoint a European Authorized Representative?
In the case of many medical devices, a European Authorized Representative (sometimes known as an EAR, EC Rep or EC/CE Representative), according to the guidelines set out under EU Medical Device Directive 93/42/EEF Article 14.2, must be designated by any manufacturer that does not have a registered address inside the bounds of the European Union and until such time that the manufacturer does appoint an EAR, their products may not be made available to the European Market. If the third-party producer is located outside the European Union and does not have its own form of representation then one must be provided in order to ensure the finished product complies with European Harmonized Standards. For a more comprehensive run-down on the topic, see our recent blog post.
Do I need to appoint a Responsible Person?
A European Responsible Person in the field of cosmetics, quite like the European Authorized Representative in the field of medical devices, is a mandatory role to be designated by all manufacturers without a base inside the European Union. Since the implementation of the Cosmetic Regulation EC 1223/2009 on July 11, 2013, all manufacturers operating outside the EU zone must designate a Responsible Person to ensure standards (such as labelling, CPNP Notification, and provision of Product Information File) are adhered to. See our recent blog on the topic for more information and to find out more about Obelis’ Responsible Person services.
Do the producer’s components have/require a CE mark?
Many products, and components, require a CE mark before being accepted onto the European Market. The process of establishing whether or not a product requires a CE marking or not can be a little complex in the beginning – luckily we have a quick and easy guide to CE marking here.
Do any Notified Bodies need to be made aware?
A Notified Body is a European Union accredited organisation appointed to carry out conformity assessment procedures and issue conformity certificates. As such, a Notified Body is one of the most prominent figures in assisting a manufacturer/producer in affixing a CE marking to their product. When working with a third-party producer, the manufacturer must ensure their components will comply with any and all standards held by the Notified Body.
Based in Brussels, only minutes away from the European Commission, Obelis’ team of regulatory experts and consultants have the expertise and knowledge required to guide you through each step of the European Market introduction process. Contact us today for further information or to get a free quote.