Due to the Brexit, there will be a new route to market and product marking (UKCA). Manufacturers outside the UK will have to designate a UK Responsible person (UK REP) to register the devices with MHRA. Qserve’s office in London is officially listed with MHRA as UK REP. Qserve Group UK Ltd. has access to the MHRA database to register manufacturers devices and IVD’s as an independent consultant. Part of the responsibilities under the UK REP is to have access to and ensure the technical documentation is appropriate.
Learn more on the process, the timelines, what Qserve UK REP needs from manufacturers, and advantages of using an independent UK REP. The webinar will provide you with an overview of the next steps to ensure your continued market access in the UK from 1 January 2021.
The detailed Webinar program is as follows:
- Overview Process UK CA
- Role of the UK REP
- Timelines & grace period
- What is requested from manufacturers to start process
- Registration details
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