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Els Janssens

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In Medical Devices

Waiting for your EU MDR Certificates? 5 Takeaways on the Intended Extension to Transitional Periods

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In brief In a recent EPSCO meeting, the European Commission (“Commission”) finally confirmed that it intends to extend the transitional period under the Medical Devices Regulation 2017/745 (MDR). In parallel, the Medical Device Coordination Group (MDCG) has published a Position Paper (2022-18) that offers a supplemental or short-term solution, allowing manufacturers to benefit from an exemption under Article 97 for a temporary period. While this means that the outlook for MDR implementation is more positive, the Commission’s approach is…

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In Pharmaceuticals & Biotech

Proposal for a New EU Product Liability Directive Published

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Impact on medicines and medical devices In brief Medicines and medical devices are subject to the EU’s general product liability rules, including the EU’s Product Liability Directive (PLD). The European Commission’s proposal for a new PLD seeks to make the PLD fit for purpose in the 21st century and address challenges faced by those who have suffered damage to claim compensation. In doing so, the Commission has expanded the scope of the PLD so that…

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In Pharmaceuticals & Biotech

European Court of Justice Advocate General supports a Literal Interpretation of the Global Marketing Authorization Concept

by and 6 Mins Read

In brief On 6 October 2022, Advocate General Medina issued an Opinion in three joined appeal cases brought by the European Commission, the EMA and Biogen against Pharmaceutical Works Polpharma. The opinion touches on the concept of global marketing authorization (GMA), and on the principle of mutual recognition of scientific assessments carried out by Member States authorities and EU institutions. In depth This is the first case related to the question of whether an authorized fixed combination…

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