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ATTENTION: fake certificates
By Katarzyna Mizerska on 18. December 20180Read moreWe were informed about fake MEDCERT certificates. Please note that these certificates were neither issued by MEDCERT nor are...
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China: Successful CMEF trade fair in Shenzhen
By Katarzyna Mizerska on 14. December 2018Read moreThe 80th China Medical Equipment Fair (Autumn) has taken place from October 29 to November 01, 2018 in Shenzhen,...
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EU: European Commission’s Latest Updates to Borderline & Classification Manual
By Katarzyna Mizerska on 14. December 2018Read moreOn October 30, 2018 the European Commission published the most updated version of the Borderline & Classification Manual. This...
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EU: Guide for the implementation of the MDR and factsheet for manufacturers
By Katarzyna Mizerska on 14. December 2018Read moreThe European Commission has published two documents related to the MDR – Medical Device Regulation. The first one is...
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Merry Christmas!
By Katarzyna Mizerska on 14. December 2018Read moreDear customers, business partners and friends! We would like to thank you for another successful year together. We wish...
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Survey: medical device companies insufficiently prepared for the new MDR
By Katarzyna Mizerska on 14. December 2018Read moreThe survey, conducted by Regulatory Affairs Professional Society (RAPS) and KPMG in June 2018 shows how insufficiently prepared are...
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China: successful CMEF and seminar for consulting companies
By Katarzyna Mizerska on 11. May 2018Read moreThe 79th China Medical Equipment Fair (Spring) took place from 11th April to 14th April 2018 in Shanghai, China....
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Ukraine: MEDCERT Cooperation with IMPROVE MEDICAL LLC
By Katarzyna Mizerska on 4. May 2018Read moreUkraine’s new system of conformity assessment and notified bodies for medical devices came into effect on 1 July 2017....
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EU: MDCG – The European Commission published its first guidance documents on the MDR
By Katarzyna Mizerska on 4. May 2018Read moreThe European Medical Devices Coordination Group (MDCG) has recently published its first guidance documents on the new MDR Medical...

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