Your EU, UK & US local medical device representative

Medical device and IVD regulations often require local presence to place products on respective market. With offices in the EU, UK, and US, Lea Reg acts as your designated local representative or agent, and assist medical device companies to meet the regulatory requirements.

All our services are performed according to our ISO 13485 certified quality management system.

Together with our partner companies, Clarvin, Devicia, Limulus Bio and Kickfile, we support the entire compliance process – from early pre-clinical development to Post production phase and distribution.

Your global and local partner

 

EUUS
USEU
EUUK

Our services

FROM US / UK EU

EU authorized representative

Medical device manufacturers located outside the European Union must assign an EU Authorized Representative that is based within the EU to place a medical device on the EU market. Lea Reg support non-EU based medical device and IVD companies by designating Lea Reg as

Authorised Representative within the EU in accordance with EU Regulations (EU) 2017/745 (MDR) & (EU) 2017/746 (IVDR).  Lea Reg has an ISO 13485 certified Quality Management System which ensures that our services are compliant with the Economic Operator’s obligations as specified in the MDR and IVDR.

FROM US / EU UK

UK Responsible Person

All medical device manufacturer located outside the UK with medical devices on the UK market must, as a result of Brexit, appoint a UK Responsible Person. Through our UK office, we are able to act as your UK Responsible Person and guide you through the specific UK requirements.

FROM US / UK EU

EU Importer

 

FROM EU UK / US

EU Exporter

 

FROM EU / UK US

US Agent

The United States Food and Drug Administration (FDA) requires all US based medical device and IVD companies to appoint a registered US FDA Agent. The US FDA Agent must be a resident of the United States or maintain a physical place of business in the US. The US Agent serves as a liaison between the US company and the FDA. Through our office in the US, we act as your US Agent and guide you through the specific US registration requirements.

As your local partner we support medical device and IVD companies to get global market access.

Contact

 

FULL-SERVICE SUPPORT

Our ecosystem for full-service medical device compliance

Together with Devicia, Limulus Bio, Clarvin and Kickfile, we support all your needs, everywhere, every time. Irrespective if it relates to strategy, Quality Assurance, Regulatory Affairs, Clinical Affairs, Biocompatibility, UK representation or EU Authorized Representative. 

Devicia is a full-service partner offering regulatory and clinical expertise for medical devices. As members of the technical committees’ writing medical device standards, Devicia are always up-to-date with the latest news and regulations and take part in the process of decision making.

Limulus Bio is your partner in the field of Biocompatibility & Toxicology for medical devices and support you with Risk Assessment Strategies, material guidance and Biological Evaluations.

Clarvin support and guide towards the most efficient, safe and optimal compliance strategy for medical device and in-vitro diagnostic devices.

Clarvins focus is to shorten time-to-market and make the regulatory process as predictable and reliable as possible.

Kickfile aims to simplify the process of compliance by providing a cloud-based document system supporting clinical evaluations and investigations.