Slide background
Slide background




Guidance Radio Equipment Directive 2014/53/EU

ID 4255 | | Visite: 2520 | Documenti Marcatura CE ENTIPermalink: https://www.certifico.com/id/4255

Guidance Application of the Radio Equipment Directive 2014/53/EU and status of combined equipment

This publication is only for guidance and gives an overview regarding the assessment of the application of the Radio Equipment Directive 2014/53/EU and status of “combined equipment” (non-radio product functioning with radio equipment). It shall not be considered as a binding interpretation of the existing legal framework. It neither claims to cover any aspect of the matter, nor does it reflect all legal aspects in detail. It is not meant to, and cannot, replace own knowledge of the pertaining directives, laws and regulations. Furthermore, the specific characteristics of the individual products and the various possible applications have to be taken into account.

This is why, apart from the assessments and procedures addressed in this guide, many other scenarios may apply. Manufacturer’s instructions and manuals must always be respected. Apart from the Directive itself, this guidance is based on both the content of the European Commission’s Guidelines, as well as the discussions and drafts that led to their adoption. In particular, the interpretation of the regime applicable to combined equipment represents a plausible scenario in view of the discussions that took place prior to the adoption of the European Commission’s guidelines. The guidance may however be adapted once the European Commission’s guidelines are revised and notably once the part on combined equipment is completed.

FEM 2017

Collegati

Directive 2014/53/EU on the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment and repealing Directive 1999/5/EC, 22 May 2014.

Orgalime Guide on the Radio Equipment Directive 2014/53/EU

European Commission Guidelines on the Radio Equipment Directive 2014/53/EU

Blue Guide on the implementation of EU Product Rules, 26 July 2016.

Pin It

Tags: Marcatura CE Direttiva RED

Articoli correlati

Ultimi archiviati Marcatura CE

UDI
Ago 11, 2020 58

Faq Unique Device Identification (UDI) System

Faq Unique Device Identification (UDI) System EC, 11.08.2020 The existing regulatory framework on medical devices dates back to the 1990s and consists of three Directives. Two new Regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical… Leggi tutto
Lug 20, 2020 95

Regolamento delegato (UE) 2020/1059

Regolamento delegato (UE) 2020/1059 Regolamento delegato (UE) 2020/1059 della Commissione del 27 aprile 2020 che rettifica alcune versioni linguistiche dei regolamenti delegati (UE) n. 1059/2010, (UE) n. 1060/2010, (UE) n. 1061/2010, (UE) n. 1062/2010, (UE) n. 626/2011, (UE) n. 392/2012 e (UE) n.… Leggi tutto
General Safety and Performance Requirements  Annex I  MDR
Lug 08, 2020 142

General Safety and Performance Requirements (Annex I) MDR

General Safety and Performance Requirements (Annex I) in the New Medical Device Regulation Comparison with the Essential Requirements of the Medical Device Directive and Active Implantable Device Directive As compliance with the ‘Essential Requirements (ERs)’ is the keystone for establishing… Leggi tutto
Position Paper Assogastecnici Aprile 2020
Lug 08, 2020 159

Regolamento MD: casi pratici in cui il Distributore non assume il ruolo di Fabbricante

Regolamento UE 2017/745: casi pratici in cui il Distributore non assume il ruolo di Fabbricante del DM Position Paper Assogastecnici A differenza della precedente regolamentazione relativa ai Dispositivi Medici (Direttiva 93/42/CEE), il nuovo Regolamento (UE) 2017/745 identifica e definisce alcune… Leggi tutto

Più letti Marcatura CE

Giu 26, 2019 56801

Regolamento Prodotti da Costruzione (UE) 305/2011 - CPR

Regolamento CPR (UE) 305/2011 Regolamento (UE) N. 305/2011 del Parlamento Europeo e del Consiglio del 9 marzo 2011 che fissa condizioni armonizzate per la commercializzazione dei prodotti da costruzione e che abroga la direttiva 89/106/CEE del Consiglio (Testo rilevante ai fini del SEE) GU L 88/10… Leggi tutto