Whereas the EU is an economic and political union, it is still not one single country.
It requires a professional representative to support you in navigating the complexities of changing legislation along with economic and political upheavals across any and all of the 27 EU Member States and 3 EFTA countries.
The majority of European, British and Swiss regulations require a professional representative for the products you market on their territory. Our representatives support you in complying with changing regulatory requirements.
Your Authorized Representative
For medical devices and in-vitro diagnostic devices, the EU Regulations (MDR and IVDR) prescribe that non-EU manufacturers must appoint an EU-based authorised representative (AR) that plays a pivotal role in compliance of their devices and acts as a contact point in the EU.
For cosmetics, the EU Cosmetics Regulation stipulates that only products for which a Responsible Person (RP) in the EU has been designated can be placed on the market. The RP takes care, among others, of documentation review, notification to the CPNP, and post-market surveillance activities.
Since 1988, Obelis’s core business has been to provide representative and consultancy services to manufacturers that want to enter the EU market. Our headquarters in Brussels is in the heart of the European Union, and we closely cooperate with the EU institutions. We participate in the European Commission Working Groups and Horizon Europe, the EU program for research and innovation. In this way we have shaped the compliance industry over the years.
Furthermore, Obelis is a member of the European Association of Authorised Representatives (EAAR) and a founder of the European Responsible Person Association (ERPA), which aims at promoting high standards of services and professionalism.
We recommend choosing a professional representative for your Company in the EU. Obelis offers:
- A team of experts that will guide you through the compliance process
- Confidentiality of information shared with us
- No conflict of interests since our business is not manufacturing and selling products
- Constant updates on regulatory changes
Since its foundation, Obelis has grown, and today it is the largest centre in Europe for regulatory compliance. Our experts can help you enter the EU, UK, and Swiss markets.
We register your Medical Devices & IVDs in Europe in 8 working days!
Since Brexit, non-UK manufacturers (including EU companies) must have a UK-based Responsible Person (UK RP) for their products: medical devices, IVDs, and cosmetics.
Obelis UK provides professional representation and consultancy services to companies that would like to place their products on the UK (Great Britain) market. We have a strong understanding of regulatory requirements and the appropriate experience to help our clients enter the UK market while ensuring the safety of their products. Our motto is to create safer markets.
Moreover, Obelis UK is a member of the UK Responsible Person Association (UKRPA). Through the UKRPA, we cooperate closely with the Medicines and Healthcare products Regulatory Agency (MHRA). Hence, we will be able to provide our clients with the latest updates in a timely manner.
Switzerland and the European Union did not update the Mutual Recognition Agreement on medical devices in light of MDR and IVDR. As a result, non-Swiss based manufacturers must designate a Swiss-based Authorised Representative (CH-REP) to market their medical devices and in-vitro diagnostic devices in Switzerland.
You can appoint Obelis Swiss GmbH as your CH-REP, and our team of regulatory professionals will assist you reaching compliance.
QA: Medical Devices & In-Vitro Diagnostics
Key guidance document based on the most frequently asked questions from our medical device and in – vitro diagnostic manufacturers. This document has been conceived to provide information on the impact of the new IVDR and MDR.
QA: Change of Authorized Representative
Choosing the right Authorized Representative (EC REP) is important to your business as it enables your sales and secures your compliance on the European market. At Obelis, we provide a transparent overview of the regulatory process from the very beginning and we can take over your regulatory documentation with minimal disruption to your business.