MHRA Introduces New Information System.
Manufacturers who sell products in the UK will now be asked whether they would like to provide additional information about their products on a voluntary basis.
What Information is Shared?
Shared information includes:
- Information on the application for admission:
- Information about the applicant
- Product names and functions
- Application process and intended use
- Information about the application process
- submission date
- type of application
- Whether it is a new product or a new product variant
- Notified body processing the application
- Information about the timeline
- The expected MHRA approval date and
- The actual MHRA approval date
What is the purpose of the system?
The information is shared via the Operational Information Sharing with all notified bodies in the UK. This information should help to harmonise approval processes, timeframes and types of procedures in order to optimise forecasts and thus improve the availability of medical devices and medicinal products.
How can Manufacturers give or Withdraw their Consent?
Applicants' consent can now be given as part of the marketing authorisation application to the MHRA. This consent to share product and application information can be revoked by applicants at any time.
ForAny and All Further Questions...
Additional information on Operational Information Sharing can be found on the MHRA website.
If you have any questions about the approval process for medical devices in the UK, EU, USA or Canada, contact the experts at BEO BERLIN!
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