Medicines and Healthcare Products Regulatory Agency(MHRA) regulates all medicines and medical devices in UK. After the exit from EU ,MHRA has opportunity in how medical devices and IVDs regulated in UK. MHRA announces few plans to improve patients health & encourage innovations. To meet the global standards they will carry theUKCA marking, a new stamp of certification, replacing the CE mark. When any manufacturer want to sell their device in EU market CE mark is needed for the device but now for UK market UKCA mark will be needed . To get this done one need to have technical file and asCE mark medical device consultantwe provide guidance on UKCA marking as we have extensive experience in regulatory services.
Dr June Raine, Chief Executive of the MHRA, says: “As a regulator, our priority is to protect patients and the public and make it easier and quicker for patients to access the medical devices and treatments they need.”
一项改革的包装将适用于包括助听器，X射线机和胰岛素泵组成的医疗设备；智能手机应用和人工智能（AI）等新技术；除了某些化妆品，例如真皮填充剂。
The new measures include :
- Strengthening the MHRA’s powers to act to keep patients safe.
- Increasing the scope and extend of the regulations.
- Addressing the health disparities and review potential equity issue in device design.
- 使英国成为推出创新医疗设备的更好地方。
- Launching a new UKCA mark which will meet global standard.
It is very clear from above points that ,Government is giving greater assurance on both the performance and safety of the highest-risk medical devices to the public and patients, such as those which need to be implanted also they are ensuring about new regulatory framework which will encourage innovation to meet patient needs. Transforming to the new stamp of certification means replacing CE mark with UKCA will boost the reputation of MHRA .
这是一项雄心勃勃的改革计划，MHRA将确保对系统的立法修改满足卫生保健部门的需求。同时，将继续与行业和利益相关者参与，同时完善立法和实施变化。
Regulatory changes in medical device is an unavoidable part for manufacturer and keeping track on that is also challenging for them .Our team ofmedical device regulatory consultantalways keep an eye on changes in regulations and provide guidance according to it ,Also we have launched a monthlyNewsletterfor the regulatory updates ,you can subscribe that to read more updates.
References :
https://www.medicaldevice-network.com/news/mhra-strengthen-medical-devices-regulation/
