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Els Janssens

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Els Janssens is a Counsel in commercial law, litigation and healthcare regulatory issues in the Brussels office. Els worked as a senior regulatory legal counsel for Johnson & Johnson supporting the company's global safety operations and advising on regulatory issues in relation to specific medicinal products. Els also worked as legal advisor in the European Medicines Agency where she advised management, scientific committees, CMD(h) and the European Commission on a wide variety of issues in connection with authorisation procedures, submission requirements, pharmacovigilance obligations and procedures as well as inspections. Based in Abu Dhabi from 2014 to 2019, she advised both multinational medical devices and pharmaceutical clients on healthcare regulations in the EU and UAE.

On 19 September 2022, the Commission unveiled its proposal for a Regulation for the New Single Market Emergency Instrument (SMEI) to secure crucial supply chains in future emergency situations. The Commission describes the SMEI as a crisis governance framework to ensure the free movement of goods, services and persons and the availability of critical goods and services within the EU during emergencies. The SMEI is not specific to health but applies to all kinds of crises having an impact on the functioning of the single market and its supply chains. ‘Crisis’ is quite vaguely defined as an exceptional unexpected and sudden, natural or man-made event of extraordinary nature and scale that takes place inside or outside of the Union.

In September 2022, the Borderline and Classification Working Group, a subgroup of the Medical Device Coordination Group (MDCG), issued a manual to determine whether a particular product qualifies as a medical device or in vitro diagnostic and into which class a particular medical device or in vitro diagnostic falls. The MDCG is operating under the Medical Device Regulation and the In Vitro Diagnostic Medical Device Regulation.

A revision of EU pharmaceutical legislation by the European Commission will be published on 21 December. These revisions indicate the execution of the European Commission’s 2020 Pharmaceutical Strategy – a strategy that seeks to create a more resilient regulatory system in light of the COVID-19 pandemic.

The European Recovery Plan will pump EUR 750 billion into the economy in the relative short term, with nearly half earmarked for climate change and digital investment. This funding will support the transformation to greener, more digital, sustainable and resilient economies, and businesses active across the EU will be able to benefit.

Manufacturers and EU importers of medical devices are periodically confronted with new sets of rules imposing new product conformity requirements. Apart from MDR/IVDR, other EU legislation as well as revisions of ISO standards may compel companies to secure future marketability of legacy products on stock before the expiry of transition periods. To take advantage of transition mechanisms, EU legislators regularly require that affected products have to be “placed on the market” prior to a cut-off date. But what does that mean, and how should companies practically implement and record a “placing on the market”?

Explore Data PULSE, a platform which helps you to navigate the complex landscape of data, regulatory and IP protection concerns at each stage of the medical product life cycle. As you navigate through each key issue, Data PULSE will help you to identify and mitigate risks across multiple jurisdictions and optimize your strategy through research, market authorization and post-market study phases.

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

The Health Pod, Baker McKenzie’s industry podcast series, highlights sector-specific issues and trends that affect healthcare and life sciences companies. Episode 5: Japan Pharmaceuticals Market – Distinguishing Features and Industry Practice Japan accounts for approximately 7% of the global pharmaceuticals market and is the third-largest market in the world following…

With the healthcare and life sciences sector at the heart of the pandemic, we are seeing some new issues arising in the already complex world of life sciences collaborations, for both coronavirus-related and other products and therapies. The Life Sciences Collaborations: Key Considerations in the COVID-19 Era document is a…