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Michalopoulou & Associates Lawgroup
Pharma & Life Sciences
Law Experts
Make change work for you. Tune in to our posts on Legal x-rays, our blog about Life Sciences & Pharma Law.
Law Under the Microscope
At Michalopoulou & Associates Lawgroup we pride ourselves on our deep engagement with the corporate and commercial dimensions of Medical, Pharmaceutical and Life Sciences Law.
Industries
Our team manages matters concerning ethics, digital health, informed consent in clinical trials under Regulation (EU) 536/2014 and personalized treatment, while empowering patients to participate in decisions about their care and to raise malpractice claims.
We advise on Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), including device classification, conformity assessment routes, clinical evaluation under MDR Annex XIV and performance evaluation under IVDR Annex XIII, technical documentation under Annex II and III, GSPR compliance, UDI assignment, EUDAMED registration, post market surveillance, PMCF and PMPF plans, periodic safety update reports and vigilance obligations.
We deliver end to end legal services on marketing authorisation under Directive 2001/83/EC and Regulation (EC) 726/2004, on pricing and reimbursement under Law 4472/2017 and Law 5243/2025, on clawback and rebate obligations under Laws 4052/2012 and 4512/2018 and on the new EU pharmaceutical legislation package.
We advise on Regulation (EU) 2022/2065 (Digital Services Act) and on its national implementation under Law 5099/2024, on Regulation (EU) 2022/1925 (Digital Markets Act), on Regulation (EU) 2023/2854 (Data Act), and on Directive (EU) 2019/770 and 2019/771 on digital content and digital services.
Our agrofood practice covers the regulatory continuum from primary production to consumer placement, including agricultural inputs, plant protection products, contract farming arrangements and quality schemes for products of designated origin (PDO/PGI) under Regulation (EU) 1151/2012.
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Practice Areas
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We deliver legal advice across the AI lifecycle. Our firm advises healthcare companies on Regulation (EU) 2024/1689 (EU AI Act) compliance.
After years of leadership in Data Protection, Privacy and Cybersecurity Law in the Health sector, our firm understands the increased complexity of data driven business models.
Our Regulatory and Government Affairs team responds to client needs immediately and effectively across the full spectrum of Life Sciences products.
We serve client interests across the full spectrum of intellectual property in healthcare and Life Sciences.
We assist start-ups across the full lifecycle: : corporate formation under ΙΚΕ or AE, founders agreements, ESOP, etc.
Legal x-rays
The law changes at lightening speed. Keep up to date through our posts on our dedicated Life Sciences & Pharma Law blog. Make change work for you.
Michalopoulou & Associates
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