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Studio Legale Stefanelli & Stefanelli | European Union, Switzerland | 27 May 2022

The marketing of medical devices in Switzerland following the non-agreement with the European Union

With the full entry into force of the MDR, the legal framework for European economic operators working with the Swiss market has undergone major…
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Crowell & Moring LLP | USA | 23 May 2022

Recall Litigation Report: 2022 Mid-Year Recap

In the first half of 2022, manufacturers have been as busy as ever navigating recalled products and fielding the class action lawsuit that often (but…
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Studio Legale Stefanelli & Stefanelli | European Union, Switzerland | 20 May 2022

La commercializzazione dei dispositivi medici in Svizzera a seguito del mancato accordo con l’Unione Europea

Con la piena efficacia del MDR, il quadro giuridico degli operatori commerciali europei che lavorano con il mercato svizzero ha subito rilevanti…
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Osborne Clarke | United Kingdom | 19 May 2022

Medical device, clinical trial and safety rules reforms could boost UK life sciences

Innovative technology is heralded as the silver bullet to reduce burgeoning healthcare costs and improve patient outcomes. But will the regulatory…
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King & Wood Mallesons | China | 19 May 2022

China relaxes rules on lab-developed tests - but uncertainties remain

New regulations in China designed to encourage innovation in clinical trials have made it easier to test human samples in a lab setting. Lab tests on…
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Lexology PRO | European Union | 18 May 2022

Canon loses bid to quash €28 million EU gun-jumping fine

The EU’s General Court has upheld the European Commission’s €28 million gun-jumping fine to Canon for partially implementing its two-part takeover of Toshiba Medical Systems Corporation before notifying the deal under EU merger rules.
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Lexology PRO | Asia-Pacific, Australia, Brazil, etc. | 10 May 2022

Product regulation and liability: key updates and risks (May 2022)

The EU publishes its chemical restrictions roadmap, the US FDA proposes rules restricting flavoured tobacco products and China introduces stricter regulation for medical devices – plus other key updates.
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CMS Cameron McKenna Nabarro Olswang LLP | Ukraine | 5 May 2022

Wartime Flexibilities for the Life Sciences and Healthcare Sectors in Ukraine

Since russia began its unprovoked large-scale armed invasion of Ukraine, the Cabinet of Ministers (the CMU), the Ukrainian Ministry of Health (the…
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Crowell & Moring LLP | USA | 3 May 2022

Philips faces supplier class action following CPAP/BiPAP recall

After recalling its continuous positive airway pressure and bilevel positive airway pressure breathing machines in June 2021, Philips Respironics was inundated with hundreds of consumer class action lawsuits. Now, Philips faces off against a different kind of class action plaintiff – medical device suppliers. This most recent lawsuit illustrates that when a company recalls one of its......
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Moroğlu Arseven | Turkey | 29 Apr 2022

Turkish Medicines and Medical Devices Agency Inspection Services Vice Presidency Published the Audit Data of the Fourth Quarter of 2021

Inspection reports on cosmetics and biocidal products belonging to the fourth quarter of 2021 have been published by the Vice Presidency of Inspection…
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