Dear Anon I fully agree with Richard his comments.prepare fully fir the IVDR know; although you still can notify the products as seks declared at an eu country under the ivdd.
you have to have an EU rep of course in order to notify( not located in the UK!!!)But prepare for the IVDR; in order to get. Cert under the IVDR before 26 may 2022 you have to Apply at a notified body now. Technical Documentation reviews take 6-9 Months. And initial audits need to be planned an executed as well. So manufacturers now fully focus on getting the documentation ready asap to apply at a motified body for IVDR Certification. So I fully agree with Richard his remark.kind regardsAnja Wiersma chair board of RAPS Netherlands Chapter
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