Final texts of the EU MDR & IVDR (R = Regulation) have been released recently, the European Council is scheduled to hold a vote to adopt the legislation in March 2017, followed by a vote in the European Parliament in April. It is estimated that the transition periods will start sometime in the 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.
For more information see the original article
Radio Equipment Directive (2014/53/EU)
There is a new publications in the OJEU of standards harmonised under the Radio Equipment Directive:
This brings the total number of standards harmonised under the RED to 65
(compared to over 200 standards harmonised under the R&TTE Directive).
The list of harmonised standards will continue to be published every month.
Draft ETSI EN 303 446-1 V1.1.0 (2017-03)
“ElectroMagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 1: Requirements for equipment intended to be used in residential, commercial and light industry locations; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU”
Background:
This future RED harmonised standard is based on the principles given in ETSI EG 203 367 “Guide to the application of harmonised standards covering articles 3.1b and 3.2 of the Directive 2014/53/EU (RED) to multi-radio and combined radio and non-radio equipment”.
Scope:
This standard defines requirements in respect of ElectroMagnetic Compatibility (EMC) under article 3.1(b) of Directive 2014/53/EU for combined and/or integrated equipment intended to be used within residential, commercial and light industry locations.
The present document is only applicable to combined and/or integrated equipment where:
Basic EMC requirements
At least one configuration of typical intended use shall be tested with both non-radio and radio functions operating at the same time.
The configuration of the EUT should be established in order to:
Schedule for publication as a harmonised standard (under the RED):
Draft ETSI EN 303 446-2 V1.1.0 (2017-03)
“ElectroMagnetic Compatibility (EMC) standard for combined and/or integrated radio and non-radio equipment; Part 2: Specific conditions for equipment intended to be used in industrial locations; Harmonised Standard covering the essential requirements of article 3.1(b) of Directive 2014/53/EU”
Background:
This future RED harmonised standard is based on the principles given in ETSI EG 203 367 “Guide to the application of harmonised standards covering articles 3.1b and 3.2 of the Directive 2014/53/EU (RED) to multi-radio and combined radio and non-radio equipment”.
Scope:
This part of the standard sets requirements for radio enabled products designed for and intended to be used in industrial locations in respect of ElectroMagnetic Compatibility (EMC) under article 3.1(b) of Directive 2014/53/EU.
The present document is only applicable to combined and/or integrated equipment where:
Basic EMC requirements
At least one configuration of typical intended use shall be tested with both non-radio and radio functions operating at the same time.
The configuration of the EUT should be established in order to:
Schedule for publication as a harmonised standard (under the RED):
Key points:
Implementation:
The new regulation is expected to be signed into EU law by the end of May 2017.
The new regulation will take effect on 1 January 2021
Who will be effected?
The regulation only applies directly to EU-based importers of tin, tantalum, tungsten and gold, whether these are in the form of mineral ores, concentrates or processed metals, for example
Upstream companies
(ie mines / traders / smelters & refiners)
Have to comply with mandatory rules on due diligence when they import
Downstream companies
(ie traders / component producers / manufacturers & assemblers / end-users)
Official information / documents
Source: European Commission “Europa” website
Press release:
http://europa.eu/rapid/press-release_IP-16-3931_en.htm
Draft regulation:
Background:
http://ec.europa.eu/trade/policy/in-focus/conflict-minerals-regulation/
The regulation explained:
http://ec.europa.eu/trade/policy/in-focus/conflict-minerals-regulation/regulation-explained/
