EU regulatory: Pharma, medical devices and biotech

Osborne Clarke

The ‘specialized, experienced, responsive’ practice at Osborne Clarke advises on regulatory issues related to medical devices, medicinal products, and digital health technology and is frequently sought out by clients entering the EU market. A ’very good lawyer with great industry experience’, Vladimir Murovec is particularly experienced in the area of digital health technologies.

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‘Specialized, experienced, responsive’
‘We worked very well with Vladimir Murovec. Very good lawyer with great industry experience and a practical approach. Always provided helpful guidance.’
‘The Brussels EU Life Sciences regulatory practice led by Vladimir Murovec is top-tier. ’
‘Vladimir Murovec is highly knowledgeable in EU pharmaceutical regulatory law and is an invaluable resource in navigating complex regulatory frameworks. His expertise in healthcare AI regulation, a rapidly evolving field, has been particularly beneficial, providing clear and practical advice on compliance and market entry strategies. Vladimir’s ability to stay ahead of EU regulatory developments and offer insightful guidance makes working with him highly effective and efficient.’
‘The team is always available and very reactive, which is essential these days. They put themselves in their clients' shoes, which makes them a true extension of the team when needed.’
‘Benjamin Docquir is absolutely outstanding and demonstrates constantly a very pragmatic approach while being 100% accurate and precise.’

Kernmandanten

Afflelou Group
Alnylam Pharmaceuticals
Bepharbel Manufacturing
BioNTech
BioSenic
Chemviron
CooperVision
Epstein, Becker & Green
Grifols
Haema

Highlight-Mandate

Advising a client on the EU regulatory due diligence for the potential multi-billion acquisition of a major listed medical device business, covering compliance with Medical Devices Regulations and related laws across several jurisdictions.

Advised a healthcare company active in the EMEA region on interactions with healthcare professionals and organisations through a medical education services provider, interpreting various codes of conduct, ensuring compliance with donations and grants regulations, and assessing potential contract terminations under local laws.

Assisting a listed Korean client in identifying and complying with the EU regulatory framework for reproducibility studies to assess various parameters of in-vitro diagnostic assays. Reviewing and advising on collaboration agreements, registration, and notification requirements under EU regulations, reporting and disclosure obligations, and addressing legal and regulatory issues for clinical studies.

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