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Next in our sector-focused series - Life Sciences. We have spoken with our in-house PSLs to outline the key legal trends to watch in Life Sciences as 2019 draws to a close.
This article focuses on the following key trends: the shake up of regulation in medical devices, the new clinical trials regulation - and expected developments for 2020 - personalised medicine and big data, and cannabis based medicine.
Look out for similar 'Trends to Watch' articles from the series, focusing on different industry sectors and practice areas.
The regulation of medical devices has been overhauled and two new EU regulations, Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746, (the In Vitro Diagnostic Medical Device Regulation, IVDR) will apply from 26 May 2020 and 26 May 2022 respectively.
The reform was prompted by safety concerns relating to a number of devices, including some metal-on-metal hip implants and PIP breast implants, which highlighted gaps in the existing regime, as well as by recognition that the existing 20-year old regime was no longer fit for purpose given the significant technological advances in medical devices during that time. Such incidents also shed light on inconsistencies in the assessment methods of different certification bodies (known as Notified Bodies) and the need for more rigorous controls and monitoring of Notified Bodies by Member States, as well as the involvement of independent experts in the assessment of certain high risk devices. The new regulations therefore aim to improve the quality, safety and reliability of medical devices, strengthen transparency for consumers and enhance vigilance and market surveillance.
The new MDR and IVDR introduce significant changes to the medical device regulatory framework including extending the range of products that are subject to device regulation. This means that there will be many producers of previously unregulated products (eg, app developers and producers of aesthetic devices such as coloured contact lenses that do not correct vision) who are for the
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