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 the UKCA 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 as CE mark medical device consultant we 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.”
The package deal of reforms will apply to medical devices consisting of hearing aids, x-ray machines and insulin pumps; new technologies like smart phone apps and artificial intelligence (AI); in addition to certain cosmetic products like dermal fillers.
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.
- Making UK as better place to introduce innovative medical devices .
- 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 .
This is an ambitious, transformational programme of reform and the MHRA will make sure that legislative modifications to the system meet the need of the health care sector. There will be continued work and engagement with industry and stakeholders whilst refining legislation and implementing changes.
Regulatory changes in medical device is an unavoidable part for manufacturer and keeping track on that is also challenging for them .Our team of medical device regulatory consultant always keep an eye on changes in regulations and provide guidance according to it ,Also we have launched a monthly Newsletter for the regulatory updates ,you can subscribe that to read more updates.
References :
https://www.medicaldevice-network.com/news/mhra-strengthen-medical-devices-regulation/
