Medilink News Summer 2021 - Page 3

KEVIN KIELY , Chief Executive , MEDILINK NORTH OF ENGLAND LIMITED
The COVID-19 pandemic has created challenges , the likes of which we have never experienced in our lifetime . As we now begin to look forward it is important that we learn the lessons of the past 18 months and that we take time to reflect on some of the amazing achievements of the life science community across the North of England . In this issue of Medilink News we pick out just a few of these success stories . It was great to have the Vaccine Deployment Minister , Nadim Zahawi , in his opening address to the Medilink Awards , acknowledge and express his heartfelt thanks to the life science community across the North for their invaluable contribution to the pandemic response . One of the key lessons for me from our pandemic response , is how when faced with a clear problem which needed an urgent solution , the NHS , industry , the scientific community , regulators and government agencies came together to fast track the development and adoption of life saving products and new ways of working . This level of collaboration and shared risk must be maintained if we are to tackle health inequality and transform health delivery . To this end we applaud the Governments recently published Life Science Vision , but recognize that visions need to be operationalized and collaboration to achieve this must be real and meaningful . The key challenges that companies faced before the pandemic have not of course gone away .
With Brexit , businesses are experiencing serious delays and costs associated with export documentation , freight costs have rocketed , this situation being made worse by the UK truck driver shortage , and issues are being experienced around certificates of origin and certificates of free sale . Medilink are in active discussion with government on these issues . I would point out that such issues should not discourage companies from internationalising , as 96 % of the medical devices market for example , is outside of the UK . Our international team are on hand to help you get back up to speed with exports and support you at exhibitions which are now beginning to open up ( Medica – 15th – 18th Nov and Arab Health ). The EU Medical Devices Regulations ( MDR ) were fully implemented on the 26th May 2021 , although in most cases current CE mark certificates continue to apply and companies are still struggling to resource and cover the costs of the more stringent clinical evidence requirements of MDR . Huge challenges also exist for diagnostic companies with the scheduled implementation of In Vitro Diagnostic Regulations ( IVDR ) on 26 May next year . Whilst CE marking will continue to be recognised in Great Britain , under the old directives , we are awaiting a draft of the UKCA mark proposals . Given that most of our members continue to trade with Europe they are keen to see an alignment between the UKCA and European regulations to avoid duplication and further costs . Medilink are discussions with government on this topic and our Innovation & Commercialisation team are available to help you transition to the new regulatory requirements . Congratulations to the winners of the Medilink North of England Healthcare Business Awards . Our national Medilink UK awards will held on a remote platform ( free to attend ) at 4pm on Friday 1st October 2021 . Joining instructions will be made available shortly .
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