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During this month of October, some diplomas were published in the scope of the CE Marking of the product. The vast majority were Communications from the European Union updating or correcting the lists of harmonized standards in some directives:
2016/C 381/01 Publication of titles and references of harmonized standards under Directive 2014/53/EU concerning the provision of radio equipment on the market
2016/C 381/02 Publication of titles and references of the harmonized standards of Delegated Regulation No. 65/2014 (complements Directive 2010 /30/EU) energy labeling of domestic ovens and kitchen hoods
2016/C 378/08 Publication of the references of the European Assessment Documents in the context of the implementation of Regulation (EU) No. 305/ 2011 which establishes harmonized conditions for the marketing of construction products
2016/C 382/07 Correctification of the Commission Communication in the context of the implementation of Directive 2009/142/EC on gas appliances
MEDICAL DEVICES
It is also worth noting the publication on 28/09/2016 of Portaria n.º 256/2016 , which establishes the principles and standards of good practice that must comply with the distribution of medical devices by entities engaged in the activity of wholesale distribution of these devices, and which are licensed for this purpose under Decree-Law no. 145/2009. The standards contained in the good distribution practices now published mainly focus on the applicable requirements:
- to distributors, to their employees, to their facilities and equipment,
- the organizational procedures to be adopted,
- documentation and records relating to its operation and rules associated with its management,
- complaints,
- device reception and shipment, storage, transport, returns,
- Procedure for collecting devices from the market and rejected products.
