- MedMira Inc. (MIR) has received the CE mark for three of seven products submitted
- The company stated that all its applications have been accepted
- Applications for the remaining four are pending but a response is expected soon
- These applications were submitted before a new Vitro Diagnostic Medical Devices Regulation
- The new IVDR is designed to regulate around 80 to 90 per cent of all In Vitro Diagnostic devices currently in the European market
- This will have a minimal impact on MedMira’s antigen test products
- MedMira Inc. (MIR) is down 4.76 per cent trading at $0.10 per share as of 2:04 p.m. ET
MedMira Inc. (MIR) has received the CE mark for three of seven products submitted this year.
The company stated that all its applications have been accepted and will be forwarded to the Competent Authority for final CE marking. Applications for the remaining four are pending, but it is expecting a response in the next few weeks.
According to MedMira, it has completed its application before changing from the In Vitro Diagnostic Medical Devices [98/79/EC: IVD] to the new In Vitro Diagnostic Medical Devices Regulation [EU 2017/746: IVDR].
EU 2017/746: IVDR is designed to regulate around 80 to 90 per cent of all In Vitro Diagnostic devices currently in the European market.
“The new IVDR regulations will have a significant impact on the overall market in terms of regulatory approval… It will be more challenging to achieve approval, and manufacturers will have to show more to access the CE market,” Hermes Chan, CEO of MedMira, said.
“In short; the entry barriers will be higher, and the quality of the products and the manufacturer will be at the focus of the regulatory bodies… This is going to change the competitive landscape in our favour, and we are delighted to have all our current and pending products ready for this change.”
MedMira stated that all previously approved in-vitro devices must be re-certified per the new requirements. EU 2017/746: IVDR will have no short-term and minimal long-term impacts on MedMira’s REVEALCOVID-19 and VYRA™ antigen test product lines.
MedMira Inc. (MIR) is down 4.76 per cent, trading at $0.10 per share as of 2:04 p.m. ET.
