WHO WE ARE
Bureau Medica Intercert DK is established with a firm mission: to simplify the complex regulatory frameworks governing medical devices, in vitro diagnostics (IVD), and healthcare products.
With the introduction of the stringent European Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746), non-European manufacturers require a reliable, knowledgeable, and independent European Authorized Representative (EC REP).
Operating directly from Denmark under verified business authorization (CVR: 45000524), we act as your official legal presence, ensuring end-to-end technical documentation compliance, direct vigilance communication, and seamless EUDAMED integration.
To deliver fast, transparent, and fully audit-proof regulatory solutions that enable life-saving medical innovations to enter global markets without compliance delays.
To be the most trusted, agile in-country representative and international regulatory consultancy for manufacturers seeking multi-continent approval.
Absolute integrity, technical precision, proactive post-market vigilance, and unwavering confidentiality for our clients’ intellectual property.
Distinct regulatory advantages engineered for global device manufacturers
Unlike commercial middle-men, our physical headquarters are based in Denmark. We hold verified legal standing with the Danish Medicines Agency (Lægemiddelstyrelsen) and the European Commission.
Manage your European (EU REP), British (UK REP), Swiss (CH REP), US FDA Agent, and Australian TGA Sponsor services under a single coordinated partner with streamlined agreements.
Appointing a commercial distributor as your legal representative puts your commercial independence and proprietary technical files at risk. We act as an independent representative safeguarding your data.
Strategic offices across four continents providing 24/7 client coordination
Kaj Sommers Vej 6, 3320 Skævinge, Denmark
Tel: +45 91632811
Technical Documentation & Regional Coordination
Tel: +91 9061033526, +91 9349208199
Illinois, USA
FDA Agent Operations
Tel: +1(630) 3468914
Dubai, UAE
GCC Regulatory Liaison
Tel: +971 526027286
Let our regulatory specialists guide your medical device to market success
Connect with our Denmark and international regulatory teams today to discuss your MDR/IVDR technical documentation, European Authorized Representation, or global registration roadmap.