The legislation of the European Union, United Kingdom and Switzerland require manufacturers to appoint a professional representative to market medical devices and IVD medical devices on their territory. Our representatives support you in complying with changing regulatory requirements.
A professional representative supports you in navigating the complex regulatory landscape in Europe and ensures that you are always up-to-date about the latest changes.
The Representation of choice for
For medical devices and in-vitro diagnostic devices, the EU Regulations (MDR and IVDR) foresee that non-EU manufacturers must appoint an EU-based authorised representative that plays a pivotal role in compliance of their devices and acts as a contact point in the EU.
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.
Since Brexit, non-UK manufacturers (including EU companies) must have a UK-based Responsible Person (UK RP) for medical devices and IVD medical devices.
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.
Compliance Success Stories
“We can always count on the quick response of the Obelis team. Managing the huge amount of data necessary for a EU Notification is very complex yet they make is seem so easy.”
“We were under huge time and cost pressure for a new product line launch and we relied on Obelis. It was the right decision. Their expert team helped us to avoid possible regulatory complications.”
“I encourage companies to seek compliance before putting their devices on the market. Working with Obelis to gain swift regulatory approval across several markets has had a profound impact on our company.”
