RE: Masks now MHRA approved8 Apr 2021 09:04
The Company confirms that the Pharm 2 Farm Limited ("P2F") Pro Larva face mask (the "Pro Larva Mask") has been approved as a Class 1 medical device by the Medicines and Healthcare products Regulatory Agency ("MHRA"). As announced earlier this year, the Pro Larva Mask was self-certified to EN 14683 standards in accordance with Government Guidelines, allowing the use of the associated CE Mark. Changes in the applicable legislation on 1 January 2021 mean that from 1 January 2022, all Class 1 medical devices, which includes the Pro Larva mask, will need to be registered with the MHRA. Following the receipt of the CE Mark, P2F registered with the MHRA earlier this year and has now secured this registration for the Pro Larva Mask so that it will continue to comply with the necessary regulations.