Erik Vollebregt
“ CE means: Call Erik”
Erik specializes in EU and national legal and regulatory frameworks for medical technology, digital health technologies, medicines, biocides, chemicals and other regulated products and services in the life sciences space for over 27 years.
As a multilingual legal expert with extensive experience at the European Commission and several leading international law firms, he provides strategic counsel on complex regulatory and legal matters across medicinal products, medical devices, in vitro diagnostics sectors, including horizontal regulation applicable, such as batteries and chemicals regulation. Clients appreciate him for his broad experience, technical expertise, quick and out of the box thinking and talent to boil very complex regulatory matters down to specific questions.
Erik’s expertise spans regulatory advice and litigation, commercial contracts, M&A transactions, and comprehensive regulatory strategy for medical technology, pharmaceutical, biotech and in vitro diagnostic enterprises.
An internationally recognized authority in life sciences regulation, Erik actively contributes to EU and national law and policy development through specialized committees at both national and EU levels and very frequent appearances on international conferences. He is strategic advisor on law and policy development in medical technology and artificial intelligence for several governments, EU institutions and industry associations.
Leveraging professional experience gained in Brussels, Amsterdam and Stockholm, Erik offers nuanced legal and regulatory insights across multiple jurisdictions. He is fluent in Dutch, English, French, German, Spanish and Swedish.
Erik is author of the foundational EU medical technology handbook “The Enriched MDR and IVDR”, the Medicaldeviceslegal.com blog and of a large amount of publications in national and international legal and regulatory journals in English, German and Dutch, including in Nature.
Practice focus
• Regulatory compliance and strategy for medical technologies, pharmaceuticals, and biologics
• Contracts in the medical technology and pharmaceutical sectors
• Litigation related to medical devices, marketing authorisations for medicinal products, and biological products
• Regulatory disputes with competent authorities
• M&A in the life sciences industry
• Navigating complex regulatory landscapes involving multiple EU and national regulations
Areas of Regulatory Expertise
Erik’s in-depth knowledge extends to key EU and national legislation relevant to the life sciences sector, including:
• European and national medicinal product regulations
• Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• Regulation on Advanced Therapy Medicinal Products (ATMPs)
• Regulations on blood and blood components
• Regulation of biological and biosimilar medicines
• REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
• Batteries Regulation
• Biocides Regulation
• General Data Protection Regulation (GDPR) in healthcare contexts
