What regulatory challenges are facing the life sciences sector?
Charleen O’Keeffe, William Fry. Image: Luke Maxwell/Siliconrepublic.com
William Fry’s Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the line.
The last year has seen a massive acceleration when it comes to digital transformation and the life sciences industry is not immune.
From game-changing technologies within the healthcare sector to the increased demand for telemedicine, there are plenty of ways digitisation is improving the industry as a whole.
Charleen O’Keeffe, a partner in William Fry’s life sciences group, spoke to Siliconrepublic.com about some of these trends in more detail. She said along with digitisation, there is also a move towards non-pharmacological intervention, the use of devices to screen for diseases and changes to the medicines themselves.
Doppler ultrasonografi hizmet alınacak yeniakit.com.tr - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from yeniakit.com.tr Daily Mail and Mail on Sunday newspapers.
Sunday, February 28, 2021
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.
The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the COVID-19 pandemic is still a major issue, the expiry of the one-year deferral is fast approaching.
The Regulation recognised that the COVID-19 outbreak and the associated public health crisis presented an unprecedented challenge to EU member states and constituted an immense burden for national authorities, health institutions, Union citizens and economic operators. Further, it recognised that the public health crisis created extraordinary circumstances that demand substantial additional resources, as well as an increased availability of vitally important medical devices, that could not reasonably have been anticipated
wheelchairs
Regulatory marking
Medical devices must have CE marking, UKCA marking or CE UKNI marking by law. This mark means that, provided you use it correctly, the device will work properly and is safe.
No device is 100% safe or reliable., The known risks of complications must be balanced in comparison to the benefits of the device, as stated by the manufacturer.
If you have any questions about weighing up the pros and cons of using a device for personal use, please speak to a healthcare professional.
Buying medical devices for personal use
Before you buy the device
Before you buy a medical device for your own use, it’s important to:
Tıbbi Cihaz Satış, Reklam ve Tanıtım Yönetmeliği nin Uygulanmasına İlişkin Kılavuz saglikaktuel.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from saglikaktuel.com Daily Mail and Mail on Sunday newspapers.