Jackie Mulryne

She assists life sciences and medical technology companies to navigate the medical devices and in vitro diagnostic regulatory frameworks and advises companies on launching digital health and AI technologies.

Jackie has significant experience with the EU and UK regulatory authorities responsible for overseeing these product areas, including the European Medicines Agency (EMA), the Medicines and Healthcare products Regulatory Agency (MHRA), and notified bodies. Clients turn to Jackie for assistance in contentious disputes due to her extensive background in public and administrative law litigation, assisting clients with sensitive internal investigations and regulatory inspections, and defending enforcement actions by the competent authorities. She also coordinates such matters across Europe. Jackie advises on a wide range of actions arising from the decisions of regulatory bodies and represents clients challenging public procurement tenders.

Committed to pro bono work, Jackie has acted for several organizations and individuals before the UK and international courts.

Regulatory

• Represented a global biotech company in the English Court, General Court, and Court of Justice in the defense of the regulatory data protection and marketing protection for its product, and coordinated relevant actions across the EU
• Advised a global healthcare company on its pan-EU strategy to protect the regulatory data protection for its product, including in the General Court, preliminary reference in the Court of Justice, acting in the English administrative law action, and coordinating similar actions across the EU
• Advised a number of life sciences and technology companies on digital health products, including classification of AI and digital technologies and launch of such technologies within the healthcare system
• Counseled numerous life sciences and technology companies on the implications of the MDR and IVDR, including changes necessary to systems and conformity assessments procedures to ensure compliance with the new requirements, and reviewing and updating agreements with economic operators 
• Assisted a companion diagnostic manufacturer regarding its next generation sequencing technology on CE marking issues, including regulatory, market access, and advertising issues
• Counseled multiple pharmaceutical clients on issues arising from supply of devices with their medicinal products, including co-development of a novel companion diagnostic, and co-packaged devices 
• Counseled several personalized medicine companies on regulatory and compliance strategies for gene, cell therapy, and tissue engineered products, including research, manufacturing, and market access
• Acting for a medical technology company during an inspection and investigation by the MHRA relating to GxP practices, including conducting the internal investigation, considering global implications and communication with customers
• Assisted several companies on strategic investments in and acquisitions of life sciences and technology companies, including targeted regulatory due diligence and advice on regulatory contractual matters
• Represented a number of life sciences companies on challenges to public procurement tenders in the UK 
• Represented two biotech companies and a pharmaceutical company in their European General Court cases in relation to transparency of clinical trial data and access to documents held by the EMA
• Represented a biopharmaceutical company in challenging the decision of the European Commission and EMA in relation to the grant of a compliance statement under the Pediatric Regulation 1901/2006/EC
• Represented a global pharmaceutical company in its judicial review challenges to amendments of the legislation on the pricing of medicinal products and to procurement procedures