21 May 2020, Virustatic Ltd – The UK’s trade association for the safety industry, The British Safety Industry Federation, confirms Virustatic Shield’s classification as a face covering. We welcome the move, which provides much-needed clarity for all our customers.
This places Virustatic Shield in line with the UK Government’s recent advice (updated only this week) for the general public to wear a non-medical face covering “where social distancing isn’t possible.”
The Virustatic Shield is a unique product. It hasn’t until now fitted simply into any one category. Is it a mask? Is it a face covering? Is it personal protection? In a way, our snood, with its protective protein coating, has been seen as all three.
The regulatory landscape has been ever-changing throughout lockdown as authorities struggle to respond to the Covid-19 pandemic. During this time, we had advice from the Government, regulators and notifying bodies that have guided us towards classifying our product as not a medical device but a PPE device. This meant the product had to carry a CE Mark and had to comply with the correct classification. We were told we had to comply with EN 149:2001+A1:2009 – the standard for disposable Respiratory Protective Equipment (RPE).
But now that advice has changed.
Your continued health, safety and wellbeing is our top priority. So, getting the correct CE classification was our number one goal and we continued to correspond with all appropriate authorities to ensure we were always classified correctly.
Throughout our journey with this product, we have always endeavoured to be transparent with our customers. But we have been operating in an ever-changing regulatory landscape and at times it has proven difficult to obtain clarity from notified bodies who can help further with classification.
We now feel we have clarity. The British Safety Industry Federation has confirmed that our product is indeed now classed by the UK Government as a ‘face covering’. It is not PPE and does not require any CE marking or classification.
Please be assured, this in no way changes the proven anti-viral capability of the product and the Virustatic Shield will continue to adhere to any regulatory changes as required.
About Virustatic Ltd
Virustatic is a UK biotech firm. Our mission is to find lifesaving alternatives in an antibiotic resistant world. Our technology has numerous applications across many sectors. We united a team of scientific partners and facilities to help combat a real and growing threat from the spread of infections.
And we have worked closely with our academic and research partners for several years to make sure our research and development is world-class.