Medovate well prepared for UKCA/CE mark certification
With the UK/EU trade deal now in operation, businesses in Cambridge have been adapting to new trading regulations – a process which medical devices company Medovate had already gone through well ahead of January 1.
For Medovate, which spun out of Health Enterprise East in 2017, 2020 was very productive. Its SAFIRA – SAFer Injection for Regional Anaesthesia – single-operator technology for regional anaesthesia was launched a year ago, and progress has been swift.
“We now have approval to sell into Australia, and are awaiting final approval for New Zealand. We also got approval for Israel just before Christmas, and shipped out our first order straight away – the boxes had been waiting at the door awaiting certification.”
A distribution deal with French company Vygon has ensured coverage in the EU continues.
“For us, 2021 is really a year to launch SAFIRA with Vygon, our major European partner – we signed a deal for 60 European companies and will be starting with those based in France and Spain.”
Next up is ENDOVAC, a ground-breaking progression of Endoluminal Vacuum Therapy (EVT) for those who get a hole in their upper GI tract (eg from ulcers).
“We’re looking to bring ENDOVAC to the market as soon as possible.”
Meanwhile, Brexit has created more paperwork – but not in the way you might think. The certification process – applying for a CE mark to sell goods into the EU – is the same as before: it is just that to sell into the UK, medical devices will need a separate certificate.
“A separate process has been set out by the MHRA, the Medicines and Healthcare products Regulatory Agency, in their guidance,” explained Alan. “We need to submit documentative evidence to an authorised body such as the BSI, who review everything submitted and grant a UKCA [UK conformity assessed] mark.
“While that mark is not recognised in Europe, the system for applying for a CE mark is in place, and we’ve been doing that already. The two systems are run in parallel, so that means two separate submissions.”
Products with an existing CE mark are recognised until mid-2023, except in Northern Ireland.
“The CE mark is recognised indefinitely in Northern Ireland, and a UKCA mark will be required for goods from the UK mainland to be sent to Northern Ireland, due to the Irish Sea trade line,” said Alan.
“The medical devices industry has been well prepared and the MHRA has been pretty active, though one future concern is that I hope the UK doesn’t diverge from dual standards as that would make the application process more complicated.
“We were well prepared and not surprised to see medical devices not being mentioned in the trade deal.
“The industry has been deciding regulatory changes and Brexit arrangements for some time, and making the changes accordingly.”
One of the changes has been to get a Medovate representative on EU territory.
“A new stipulation is that anyone bringing medical devices into the UK will need to have a recommendation, so we have appointed an EC representative in Malta, with a company that also has a UK office, so that allows us to comply with EU regulations,” added Alan.