Transcription of MDCG 2021-26
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MDCG 2021-26
Medical Devices Medical Device Coordination Group Document MDCG 2021-26 Page 1 of 8 MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 October 2021 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission.
Medical Devices Medical Device Coordination Group Document MDCG 2021-26 Page 4 of 8 Question 4 Is the splitting-up of large quantities of devices in shipping containers4 into smaller quantities of devices in packages or individual units covered by Article 16(2)?
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