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The MDCG has published a guidance document in which it sets out the specifications for distributors, importers and notified bodies in accordance with Article 16(4) in more detail. This describes the prerequisites for a situation in which distributors or importers repackage medical devices or translate associated information without becoming manufacturers themselves.
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EU: MDCG guidance on Article 48(6) IVDR
The MDCG has published guidance regarding the interpretation of the phrase "first certification for that type of device" in Article 48(6) IVDR. This article relates to a consultation procedure within the context of conformity assessment for Class D products, provided no CS are available and it is the "first certification for that type of device".
In mid-July, the EU published the first implementing decisions with harmonised standards regarding the regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the Official Journal.
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EU: Guidance on the integration of UDI requirements into a quality management system
The EU has published new guidance (MDCG 2021-19), which deals with the processes required for the creation and maintenance of the UDI, as well as their integration into the manufacturer's quality management system.
EU: MDCG guidance on IVDR codes
The new MDCG 2021-14 contains explanatory information about the codes, which includes the scope of the designation for the notified body.
As part of the consultation procedure in accordance with Article 54 MDR for specific products in Class III and IIb, the EU has published the first scientific report from an expert committee
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The EU has published a revised guidance document (MDCG 2021-13), which answers questions regarding EUDAMED registration of actors other than manufacturers, authorised representatives and importers.
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The EU has published a number of new MDCG guidance documents.
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