The sponsor of a clinical investigation - who is not established in the EU - has to appoint a natural or legal person inside the EU as his 'Legal Representative'. As professional full service provider (with medical and clinical expertise in house) we're looking forward to act for you as 'Legal Representative' as defined in MDR Article 62.2 and (EU) Clinical Trial Regulation 536/2014.
After accepting ‘Letter of Authorization’ we
- unlock the EU to your clinical studies
- provide representation to your medical device study
- cover representation as enforced by the General Data Protection Regulation (GDPR)
- verify your compliance with applicable obligations
- will be seen by the authorities as liaison in the communication with you as sponsor.
Please contact our office for more information: This email address is being protected from spambots. You need JavaScript enabled to view it.