Fragezeichen

Creation of  Conformity Documents

Even the simplest electrical products are now available with remote control (keywords: Bluetooth, WIFI, radio, app),that means a radio interface is integrated in the product. Experience has shown that the german Federal Network Agency (Bundesnetzagentur) is particularly active in this area.

And that's not surprising. Among other things, also about the permitted use of radio frequencies. The radio directive (RED) 2014/53 / EU / should not be equated with the EMC directive 2014/30 / EU. Even if tested and certified radio modules are used, this does not automatically mean that the end product also complies with the RED directive. This can only be derived from the existing documentation of the radio module and the end product and must always be clarified individually.

 Does a “notified body” have to be activated? Have harmonized standards been used? Are there harmonized standards?

Answering these questions is a difficult task and can hardly be carried out without specific knowledge for the dealer (conformity responsibility / distributor / (quasi) manufacturer).

Checks of the conformity documents by competent persons and optionally an assessment of the suitability for traffic through a random assessment of the product with regard to conformity with guidelines and standards, reduce the risk of a high economic damage considerably.

You cannot rely on an exclusive CE declaration (conformity with the Directives and regulations) from the manufacturer .

Compliance with the harmonized standards published in the Official Journal of the EU is essential.

Request a non-binding offer to prepare the conformity documents.and simply allocate the costs for these external activities to each individual product. You will be amazed at how marginal the cost share / piece is.

The cost of a sales ban or a recall is no longer marginal!
The offer includes the request for all (missing) documents from the manufacturer.

Please contact me if you are interested.  

 

 

 

 

 

                    

Harmonized standards - actual directives - New regulations - EK1-Decisions - AfPS GS 2014:01 -  TRF - Identity tests - EMF - RED - EMC - LVD - LFGB- ErP - Stand-By-VO - ROHS - WEE - Eprel - Lucid........

 

Wissenswertes

Seit 1985 werden die EG-Richtlinien nach der sogenannten Neuen Konzeption entwickelt; bisher sind 26 euroäische Richtlinien verabschiedet worden, die zu ihrer Umsetzung Europäische Normen benötigen. Diese sind unverzichtbar, da die EU-Richtlinien keinerlei detaillierte technische Spezifikationen formulieren, sondern nur grundlegende Anforderungen festlegen, die sich vor allem auf den Gesundheitsschutz und die Sicherheit der Nutzer beziehen. Insofern werden hier die zu erreichenden Ergebnisse sowie die abzuwendenden Gefahren und Risiken definiert, ohne dass zugleich die technischen Lösungen dafür festgelegt werden.  Diese wiederum finden sich in den sogenannten harmonisierten Normen, die den Herstellern als Hilfestellung zur Risikoanalyse und bei der Umsetzung der grundlegenden Anforderungen dienen. Werden Produkte nach diesen Normen entworfen und hergestellt, wird davon ausgegangen, dass sie den für sie geltenden grundlegenden Anforderungen der jeweiligen EU-Richtlinie entsprechen (Konformitätsvermutung). Diese europäischen Normen werden in jedem EU- und EFTA - Land im Rahmen ihres nationalen Normenwerks einheitlich umgesetzt.

Quelle :

(https://www.baua.de/DE/Aufgaben/Gesetzliche-und-hoheitliche Aufgaben/Produktsicherheitsgesetz/ Normenverzeichnisse_node.html)

All of these are terms that are directly or indirectly related to the preparation of conformity documents and other legal provisions

In online trade in particular, the focus of the regulatory authorities on Asian products is increasing.

Asian products clearly top the list of dangerous and potentially dangerous products published in the EU's RAPEX rapid alert system, which are usually associated with sales bans or product recalls. Such actions can affect entire stock levels through an ordered sales ban, i.e.The consequences can be far-reaching economic consequences, including bankruptcy of the dealer. And that would not be an individual  case.The same also applies to ordered recall campaigns. Such campaigns can be critical without a functioning recall management, with the same consequences as with a sales ban.

You can minimize these risks if you understand how to correctly interpret and verify the manufacturer's required compliance documents and to make the manufacturer aware of weaknesses, inconsistencies, missing technical documentation or incomprehensible documents and test results.

Panorama1

<              >