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Tag Archives: regulation

LRQA withdraws MDR and IVDR services

Are you affected by the LRQA announcement? The  LRQA has  given 90 days’ notice that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR).  They…
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Changes & Challenges – joint event with Sheffield Assay Office

The Sheffield Assay Office opened its doors to business owners and professionals to welcome them to an event looking at key current topics for healthcare and life science companies such as global regulation, selling to the NHS and the role of intellectual property. At the event the team from the Sheffield Assay Office gave a…
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Global Medical Device & IVD Regulations: What You Need to Know

With the implementation dates for the new EU Medical Device and IVD regulations looming (May 2020 & May 2022 respectively), companies are having to get their heads around the implications of greater levels of oversight for healthcare technologies where, for example, additional clinical evidence requirements are likely to impose a significant cost. Furthermore, the EU…
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