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NEW: Video on the transfer from the MDD to the MDR
By Katarzyna Mizerska on 26. December 20190Read moreWe urgently would like to point out that the preparation for the transfer from the MDD to the MDR...
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EU: New MDCG guidance on MDR codes
By Katarzyna Mizerska on 18. December 2019Read moreThe lists of codes and corresponding types of devices established by the MDR Regulation takes into account various device...
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EU: New MDCG Guidance document on sampling for Class IIa and IIb devices under the MDR
By Katarzyna Mizerska on 18. December 2019Read moreThe Medical Device Coordination Group (MDCG) has recently published new guidance document on MDR. The guidance is intended to...
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MEDCERT at MEDICA in Düsseldorf
By Katarzyna Mizerska on 7. November 2019Read moreThe world’s largest medical device trade show takes place from 18 to 21 November 2019 in Düsseldorf, Germany. You...
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MEDCERT successfully re-designated according to MDD and AIMDD
By Katarzyna Mizerska on 4. September 2019Read moreWe are pleased to inform you that MEDCERT has been successfully re-designated according to Directives 93/42/EEC (“MDD”) and 90/385/EEC...
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ATTENTION: fake certificate
By Katarzyna Mizerska on 30. August 2019Read moreWe were informed about a fake MEDCERT certificate. Please note that this certificate was neither issued by MEDCERT nor...
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EU: European Commission names UDI Issuing Agencies
By Katarzyna Mizerska on 30. August 2019Read moreThe European Commission has designated four organizations as Unique Device Identification (UDI) Issuing Agencies to support medical device and...
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EU: guidance on use of symbols for the MDR
By Katarzyna Mizerska on 30. August 2019Read moreThe European association MedTech Europe has published an overview on symbols, which shall be applied on the medical devices...
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USA: MEDCERT at the RAPS Regulatory Convergence in Philadelphia
By Katarzyna Mizerska on 30. August 2019Read moreFrom 21 to 24 September, 2019 the RAPS Regulatory Convergence 2019 takes place in Philadelphia, Pennsylvania. You are very...

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