Marking of Conformity Assessment

Transcription

1 Marking of Conformity Assessment R T XY1234 AC MIC MRA International Workshop 30 th March 2012 Jan Coenraads Jan.coenraads@brynyago.com

2 Comparison of Conformity Assessment Radio Act, Telecom Business Act R&TTE Directive CFR47 R&TTE Certification SDoC Reg Certification SDoC Certification SDoC Reg R T 003XY1234 AC Dec Dec EMC Voluntary SDoC EMC Directive DoC CFR47 LVD Electric Safety Law LVD SDoC SDoC Directive Federal/ NO State/Yes

3 The MRA Contracts for EU Regulation Japan EU: R&TTE Directive USA EU: R&TTE Directive + EMC Directive Canada Australia New Zealand Switzerland R&TTE Directive & EMC Directive R&TTE Directive & EMC Directive R&TTE Directive & EMC Directive R&TTE Directive & EMC Directive But Special situation being in Europe

4 The MRA Players outside the EU CAB s USA R&TTED 19 EMCD 26 Japan R&TTED 2 EMCD MRA n.a. Canada R&TTED 1 EMCD 0 Australia R&TTED 0 EMCD 1 New Zealand R&TTED 0 EMCD 1 Switzerland R&TTED 0 EMCD 7 (EU total R&TTED 73 EMCD 198) Notifying Authorities USA NIST Japan Ministry of Internal Affairs & Communications (MIC) Canada Department of Industry Canada Accreditation Bodies USA NVLAP & A2LA Japan JAB?

5 Applicable EU legislation Which legislation applies to a product? For most electrical and electronics products EMC + LVD apply except for: Radio and Telecommunications Terminal Equipment (as they fall under the R&TTE Directive) When EMC risks are benign (in which case the EMC Directive does NOT apply) When products are outside the voltage range of the LVD (in which case the LVD does NOT apply) Other Directives MAY apply instead: Sector specific (e.g. marine equipment, medical equipment) Other Directives MAY apply on top: E.g. RoHS, WEE and specific chemical legislation

6 Marking Items covered 1. Classified Radio Devices 2. Alert Sign 3. Notification 4. Declaration of Conformity 5. EU Type Certificate (NEW) 6. CE Mark A lot of confusion between 1, 2 and 3! For 5 see yesterday s presentation

7 Classified Radio devices Current situation Commission Decision 2000/299/EC, based on R&TTE Directive Art. 4.1, classifies radio equipment into 2 Classes: - Class 1, including radio equipment and terminals which can be placed on the market and put into service without restrictions - Class 2, including radio equipment for which Member States apply restrictions to the placing on the market or the putting into use. Class 2 equipment shall be marked with the Alert Sign

8 The Commission needs to publish on the EU website an indicative and non-exhaustive list of equipment falling within the 2 classes. This has been implemented under the form of a publication of subclasses, later transferred to the ERO website. R&TTED Art. 6.4 obliges Manufacturers to notify to EU MS their intention to place on the market radio equipment using frequency bands whose use is not harmonised throughout the EU. Note: Classification and Notification follows different procedures

9 A CLASS 2 identifier has to be placed on the product, on the accompanying documents and on the packaging. This identifier has to be accompanied by following information: Information on the actual restriction for use (on the product, on the accompanying documents or on the packaging): EXAMPLES Equipment may not be operated A license is needed to operate the equipment A certificate is needed to operate the equipment Equipment has to be registered before operation Equipment may only be operated indoor Equipment may not be operated within 3km from an airport ; List of the countries where the equipment may be used (with or without restriction) on the packaging of the equipment; ETC, ETC

10 CE Marking CE marking shall be affixed only by: - manufacturer, or - authorized representative in EU (if mandated to do so) The affixing of the CE marking on products not covered by the appropriate Directive & Affixing of misleading marks/signs similar to CE is prohibited!! By affixing the CE marking, the manufacturer indicates his responsibility for product conformity with all relevant legislative requirements, among others - Compliance with essential requirements - fulfilling of the administrative provisions (EU DoC) - satisfactory results of properly chosen conformity assessment procedures - providing necessary information for users and for the MSA MS shall provide for penalties in case of infringements of the CE marking For R&TTED the NB Number must be added when a NB or CAB has been used. For R&TTED the Alert Sign, if applicable, shall also be added. For EMCD and LVD both requiremenst not applicable!

11 4 possible Marking Appearances (based on NEW EMC and R&TTE Directive proposal) R&TTED: Harmonised standards applied for radio aspects, no user restrictions, no NB used. EMCD: any module followed, NB could have been used. LVD: applicable. R&TTED: Harmonised standards applied for radio aspects, user restrictions, NB not used. EMCD and LVD: this is not applicable R&TTED: Harmonised standards for radio aspects not applied or module B/C applied for other aspects, user restrictions, NB used EMCD and LVD: this is not applicable R&TTED: Harmonised standards for radio aspects not applied or module B/C applied for other aspects, no user restrictions, NB used EMCD and LVD: this is not applicable.

12 Extra Information on the R&TTED DoC Apart from the information given in yesterdays presentation on the new DoC structure, the R&TTED DoC must contain the following additional information for radio equipment: Frequency band(s) or discrete frequencies in which the equipment operates (not necessary for those licensed frequencies where the equipment operates under the control of a network) Radio-frequency power linked to the frequency band(s)

13 Simplified DoC for R&TTED The simplified EU DoC accompanies each product and states: Hereby, [Name of manufacturer, or authorised representative, or importer, or distributor, as applicable], declares that this [type of equipment] is in compliance with the essential requirements and other relevant provisions of Directive XXXX/XX/EC. This simplified EU DoC shall be translated into the official language(s) of the MS in which market the product is placed or made available. In practice this would mean for the whole of the EU: 20 languages

14 2 Options available for R&TTED DoC The product has: 1. The full EU DoC in one of the official languages of the EU + the simplified EU DoC in all languages, or 2. The simplified DoC + directly followed by the exact address (Internet webpage or address) where the full EU DoC can be obtained. The full EU DoC, available at that exact address, shall be in one of the official languages of the EU. The advantage of method 2? Any change in the Full DoC text does not require changes for the documentation with the product!

15 MSA requests for DoC Following a request from a Member State Authority, the manufacturer shall provide a copy of the full EU DoC translated into the language of that Member State.

16 End of Presentation Thank you for your attention Any QUESTIONS??