à - Europa



[pic] |EUROPEAN COMMISSION

ENTERPRISE DIRECTORATE-GENERAL

Conformity and standardisation, new approach, industries under new approach

Mechanical and electrical equipment (including telecom terminal equipment)

TCAM Secretariat

| |Brussels, 12 February, 2009

Ref: (15)01 Agenda TCAM 15.doc

DG ENTR G3

TCAM 3 (09) 16 Rev. 15

Status discussion legal issues

The following table reflects the state of discussion on the legal issues.

|Description |Introducing document |Status |

|Ambiguity in Annex III of the Directive |TCAM 2 (99) 36 |Concluded in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM 2: SF, SV, NL, FR (agreement). |

| | |Conclusion: Manufacturers, when using annex III are not required to affix a notified body number if they use the essential radio tests of a |

| | |harmonised standard. |

|Application of Article 6.4 to receivers and |TCAM 2 (99) 36 |First discussion in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement). |

|discussion on the scope of equipment to be | |Issue for discussion in Workshop 13 September 1999 (TCAM 3 (99) 13). |

|notified | |Conclusion: Exemption of receivers can only be achieved through an appropriate definition of the term for “harmonised frequencies, the use of |

| | |which is harmonised throughout the Community”. Such an appropriate definition was discussed in TCAM 3, where a definition was agreed, which |

| | |includes receivers (Decision 16) |

|Clarification of the relation of the R&TTE |TCAM 2 (99) 36 |Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, (agreement), FR (partial agreement, |

|Directive with the EMC and LVD Directives | |certain issues unresolved) |

| | |Conclusion: |

| | |Standards remain to be mandated and produced under the EMC and LVD Directives; |

| | |In order to give a presumption of conformity the references however have to be published under the R&TTE Directive; |

| | |Article 10.5 is retained for aeronautical equipment. |

|Interpretation of article 6.3 for equipment, |TCAM 2 (99) 36 |Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement) |

|the use of which is harmonised in the Community| |Conclusion: manufacturers should indicate where receiving equipment is intended to be used. For receiving equipment, which is not allowed to be |

| | |used for other reasons then those covered by the Directive (e.g. radar-warning apparatus), he should in general terms indicate, that usage may be|

| | |constrained. |

|Can an equipment identifier be empty? |TCAM 2 (99) 36 |Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement) |

| | |Conclusion: it is possible to have an empty equipment identifier |

|Application of article 9.5 of the Directive to |TCAM 2 (99) 36 |Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, SV, NL, FR (agreement) |

|receive-only equipment | |Conclusion: Member States cannot invoke article 9.5 to bar receive-only equipment from their market |

|Application of Annex IV when radio equipment |TCAM 2 (99) 36 |First discussion in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, (only apply annex IV when no harmonised standards are used for |

|complies with harmonised standards for Art.3.2 | |radio parameters) NL, FR (needs further assessment), SV (Annex IV to be applied also when HS not used for other then radio parameters). |

|but not for other essential requirements | |Discussion concluded in TCAM 3: |

| | |Conclusion: In the absence of a harmonised standard annex IV has to be used. This also applies for those requirements covered by article 3.1.a |

| | |and 3.1.b of the Directive. Member States are urged to implement the Directive so that essential radio test suites would only relate to article |

| | |3.2 requirements and not to articles 3.1 or 3.3 requirements and pointed out that manufacturers could also use annex V of the Directive (Decision|

| | |3.8). |

|Possibility for Member States to introduce |TCAM 2 (99) 36 |Issue clarified by the Commission in TCAM 2 (TCAM 3 (99) 3). MS that commented after TCAM2: SF, NL (agreement) |

|requirements to enable interception of calls | |Conclusion: |

| | |Member States could invoke article 30 in such cases, subject to being able to demonstrate that the measure is necessary and proportional to |

| | |achieve the objective. |

|Possibility to place products on the market in |TCAM 2 (99) 2 Art.6 |First discussion in TCAM 2 (TCAM 3 (99) 3). Discussion concluded in TCAM 3 (Decision 9). |

|the Community, which cannot be used in the | |Conclusion: |

|Community | |TCAM endorses the interpretation of the Commission that radio equipment, which is not intended for use in the Community can be marketed, provided|

| | |that the manufacturer abides by the rules of the Directive as regards marking, information to the user and notification to spectrum authorities. |

|Clarification on transitional arrangements, |TCAM 2 (99) 33 |First discussion in TCAM 2 (TCAM 3 (99) 3).. MS that commented after TCAM 2: SV (approval and placing on the market until 8/4/2001). Issue |

|seizure of type approval certificates | |clarified by the Commission in TCAM 3 (Decision 10). |

| | |Conclusion: |

| | |=8/4/2000 and =8/4/2001: conformity assessment and placing on the market for the first time only possible under 1999/5/EC |

|Interface publication for innovative services, |TCAM 2 (99) 37 |Issue introduced in TCAM 2 (TCAM 3 (99) 3). Issue clarified by the Commission in TCAM 3 (Decision 11). |

|possibility for Member States to position an | |Conclusion: |

|NTP at the user side of the terminal | |NRAs can within their discretion decide that publication of interfaces of innovative services could be done immediately before service offering. |

| | |It is not possible to exempt operators from their obligations under article 4.2 and it is thus not possible to place the NTP at the user |

| | |interface with terminal equipment. |

|Limitations, posed by WTO obligations and |TCAM 2 (99) 26 |Issue introduced in TCAM 2 (TCAM 3 (99) 3). Issue clarified by the Commission in TCAM 3 (Decision 12). |

|obligations of Member States under article 28 | |Conclusion: |

|of the Treaty on the possibility for Member | |No general rules can be defined justifying spectrum regulation. “Efficient use of the spectrum” and “avoidance of harmful interference” are |

|States to regulate interfaces | |valid reasons for spectrum regulation but that there may be other public interest reasons. |

|What notified body number is to be affixed if |TCAM 3 (99) 14 |Issue clarified by the Commission in TCAM 3 (Decision 13). |

|more than one notified body is involved (Annex | |Conclusion: |

|IV, or a different notified body is involved | |The numbers of all notified bodies, which are involved in the conformity assessment procedures need to be affixed. |

|for annex III and Annex IV) | | |

|Clarification of Manufacturers, representatives|TCAM 3 (99) 14 (Example 1, |Issue clarified by the Commission in TCAM 3 (Decision 14). |

|or persons responsible for placing on the |Example 2) |Conclusion: |

|market | |The tasks of a manufacturer fall on an importer, where that importer has affixed the CE mark on a product. |

|Notification to the Member States of |TCAM 3 (99) 14 |Issue clarified by the Commission in TCAM 3 (Decision 16). Follow-up issue under 20. |

|non-harmonised radio products | |Conclusion: |

| | |Notification under Article 6 (4) of Directive 1999/5/EC is required for equipment covered by the following definition: Radio equipment which uses|

| | |frequency bands whose use is not harmonised throughout the European Union. This is considered to be all radio equipment except those: |

| | |which do not transmit; or |

| | |which can only transmit under the control of a network or otherwise automatically adapts without user intervention so as to never harmfully |

| | |interfere wherever deployed in the EU; or |

| | |which transmit exclusively in frequency band(s) which are allocated to the same radio interface in every Member State in the following way: |

| | |there is a common frequency allocation; and |

| | |within this allocation, the allotment and/or assignment of radio frequencies or radio frequency channels follows a common plan or arrangement; |

| | |and |

| | |the equipment satisfies common parameters (e.g. frequency, power, duty cycle, bandwidth, etc.). |

| | |Notification of radio equipment which uses frequency bands whose use is not harmonised throughout the Community should be made to relevant Member|

| | |States, i.e. Member States upon whose market it is intended to place the equipment. |

|Interpretation of article 12.3 |TCAM 3 (99) 14 |Issue clarified by the Commission in TCAM 3 (TCAM 3 (99) 42 Ch.8). |

| | |Conclusion: |

| | |Member States have the obligation to ensure that action be taken against ill marked equipment. Article 12.3 has to be read in conjunction with |

| | |article 9.1. In this context Member States also have to take account of their obligations under article 10 EC. |

|Liability of the signatory of a declaration of | |Issue clarified by the Commission in TCAM 4, (TCAM 4 (99) 43 §1) |

|conformity | |Conclusion: |

| | |Only in exceptional cases would the signatory of a declaration of conformity be liable for wrongly signing a declaration of conformity. In first|

| | |instance the company would be liable.. |

|Committee procedure to be used when consulting | |Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §2) |

|TCAM on the appropriateness of a national | |Conclusion: |

|application of article 9.5 | |The consultation is purely informal, as the opinion is not related to a Commission Decision. Therefore neither the consultative nor the |

| | |regulatory Committee procedures apply. |

|Publication obligations of operators, which | |Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §3) |

|already offer services | |Conclusion: |

| | |Operators, which already offer services have to publish their interfaces by 8 April 2000. |

|Interpretation of the term “relevant Member |TCAM 4 (99) 13 |Follow-up issue from 15. Issue clarified by the Commission in TCAM 4. |

|State” in article 6.4 of Directive 1999/5/EC | |Conclusion: |

| | |The majority interpretation given in TCAM 3 (See Decision 3.16) is compatible with article 6.4: Member States upon whose market it is intended to|

| | |place the equipment but where the equipment is not complying with the national frequency use. |

| | |An interpretation, which would also request notification of equipment, which complies with the national frequency use is however not incompatible|

| | |with article 6.4 |

|Obligation of manufacturers to include their | |Issue clarified by the Commission in TCAM 4 (TCAM 4 (99) 43 §6) |

|name as part of the marking under article 12.4 | |Conclusion: |

| | |The name of the manufacturer (i.e. the entity taking responsibility for compliance with the Directive) needs to be put on the equipment |

|Procedure to use for the notification of |TCAM 2 (99) 2, |First discussion TCAM 5 (TCAM 5 (00) 31 #1). Commission stated its position. Certain Member States considered that notification wasn't required|

|interface regulations, application of Directive| |under Directive 98/34/EC. Issue concluded in TCAM 6, where delegations supported the position of the Commission that, where national interface |

|98/34/EC | |regulations define technical requirements, which products have to meet in order to be used, their drafts need to be notified under Directive |

| | |98/34/EC. Otherwise they need to be notified under Article 4.1 of the R&TTE Directive. |

|Coverage of components by the R&TTE Directive, |TCAM 5 (00) 31 Annex 1 |Discussion concluded in TCAM 5 (TCAM 5 (00) 31 #2). |

|example of blinking antennas | |Conclusion: Such components affect the characteristics of the transmitter on which they are to be mounted and therefore potentially affect the |

| | |compliance with the Directive. They are covered by the Directive and therefore need to comply with its provisions (Decision 5.2). |

|Form of the manufacturers' declaration to be | |A first discussion took place in TCAM 5 (TCAM 5 (00) 31 #3). Discussion concluded through written procedure in June 2000 (TCAM 6 (00) 30). |

|put into the users manual | |Conclusion: |

| | |A compromise was found to satisfy the requirement of the Directive that a declaration of conformity is available to the user in a language he |

| | |understands, whilst not forcing the manufacturer to have to include a copy of the original Declaration of Conformity. The manufacturer makes an |

| | |informal statement of conformity in the manual in the languages of the Community, whilst he either includes the original DoC or informs the user |

| | |on where this can be found. |

|Interface publications vs. essential | |Issue was clarified in TCAM 5 (TCAM 5 (00) 31 #4). |

|requirements | |Conclusion: |

| | |Operators should only provide a declaration on those elements, which are under their control. Telecommunication operators only need to publish |

| | |the technical characteristics of their interfaces. There may be requirements, which are beyond the control of the operator, for which he is not |

| | |in a position to provide them. Network operators however need to inform the manufacturer about the safety situation in networks, so that they |

| | |can take that into account when designing products. |

|Requirements products need to meet, which are | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #5) |

|only sold over the Internet | |Conclusion: |

| | |Equipment sold through the Internet into the EU needs to comply with the Directive. Problems however occur with the enforcement of this |

| | |obligation on non-EU commercial entities. |

|Equipment within the scope of article 1.5: do | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #6) |

|they need to be notified under 3052/95? Do | |Conclusion: |

|Member States have to exempt them from the | |Member States are not obliged to exempt such equipment from the Directive. Only equipment factually banned from being placed on the market |

|Directive? | |should be notified under Decision 3052/95. |

|Can Member States regulate the technology of | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #7) |

|infrastructure and put into place a type | |Conclusion: |

|approval note. | |In principle, given that the R&TTE Directive does not regulate such equipment Member States are free to continue/introduce this type of |

| | |legislation. Such legislation is however not in the spirit of the Directive and potentially a disproportionate barrier to trade. |

|Compatibility of ERC Decisions on license | |First discussion in TCAM 5 (TCAM 5 (00) 31 #8). Commission presented its position in TCAM 6. Commission to discuss an appropriate way forward |

|exemption for radio terminals with the R&TTE | |with the ERC. Commission wrote a document to the ERC for discussion in ERC Plenary (TCAM 8 (00) 6) , which referred the matter back to the |

|Directive | |working groups to respond to Action 6.7. Matter touched upon again in TCAM 8. Issue finally closed in TCAM 9 noting the Commission position. |

|What kinds of aeronautical equipment does the | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #9). |

|Directive cover? | |Conclusion: |

| | |ATMS equipment is excluded from the scope of the Directive and therefore potentially covered by national regulations. It needs to be studied, |

| | |whether this poses a problem and whether it is desirable to include them when reviewing the Directive. |

|Are Radars covered by the Directive? | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #10). |

| | |Conclusion: |

| | |Radars are covered by the Directive |

|When do Commission Decisions have to be | |Issue clarified in TCAM 5 (TCAM 5 (00) 31 #11). |

|applied? | |Conclusion: |

| | |Commission Decisions have to be applied as of the date of notification to the Member State. Where such would cause problems, appropriate interim|

| | |periods could be build into such Decisions. |

|Conformity assessment procedures and relation | |Continuation of issue 3. First discussion in TCAM 5 |

|with EMC and LVD | |Conclusion: |

| | |Article 10.5 of the EMC Directive did not further apply to equipment within the scope of the R&TTE Directive. |

|Declarations of Conformity for equipment within| |The matter was discussed in TCAM 6. Matter to be finalised through e-mail (Action 6.8). Discussion in TCAM 7 demonstrated diverging views. |

|the scope of the R&TTE Directive | |Commission to draft a ‘modus vivendi’ proposal for TCAM8 (action 7.4). This proposal (TCAM 8 (01) 30) was supported by delegations in TCAM 8. |

| | |Conclusion: |

| | |Noting the fact that the conformance to the essential requirements of article 3.2 and 3.3 can only be declared against the R&TTE Directive it is |

| | |agreed to: |

| | |Leave it to the manufacturer to declare in the original DoC the conformance of a product to the requirements of article 3.1.a (electrical safety)|

| | |and article 3.1.b (EMC) either against the EMC resp. Low Voltage Directive or the R&TTE Directive. |

| | |Insist on the reference to the R&TTE Directive in the user documentation |

|Clarification on information, which could be | |The matter was concluded in TCAM 6 (TCAM 6 (00) 49 #2), where Member States shared the analysis of the Commission: |

|requested in an article 6.4 notification | | |

| | |Member States shall require manufacturers, in the context of article 6.4, only to notify information on the intentional transmissions of radio |

| | |products. |

| | |They cannot therefore request manufacturers to notify the following types of information, which have been found in the forms of certain Member |

| | |States: |

| | |information related to compliance with the essential requirements of the Directive: compliance with the essential requirements is ensured through|

| | |the conformity assessment procedures and any problems are to be handled through the safeguard procedures of the Directive; |

| | |a statement of compliance with certain standards: compliance with standards isn't mandatory and therefore cannot be required; |

| | |Information on where equipment will be marketed: such information isn't relevant for a national authority. The only information, which is |

| | |relevant in this context is information on areas, for which usage is intended. |

|Conformity assessment procedures to be followed| |Discussion concluded in TCAM 6. Conclusion that the issue cannot be resolved in the current legal framework and that therefore the situation can|

|for low power radio transmitters which don't | |only be resolved in the review or by the adoption of a suitable harmonised standard. |

|risk to cause safety problems | | |

|Exclusion of broadcast receivers and | |Discussion concluded in TCAM 6 (Decision 6.10). TCAM shared the position of the Commission that receivers, capable of listening into both |

|ambiguities caused | |broadcasting and other bands are covered by both the EMC and LVD for their functioning in broadcasting bands and the R&TTE Directive for the |

| | |other bands |

|Limitation of use of receivers and | |Discussion concluded during TCAM 6. TCAM supported the analysis of the Commission that receivers, for whom the usage or marketing is restricted, |

|classification of receivers as class 1 | |can remain within class 1. |

|Components, antennas, borderline of coverage of| |First discussion in TCAM 6. Whilst TCAM agrees that normally antennas are covered by the Directive, it would be disproportionate to have simple |

|the Directive | |antennas, e.g. GSM replacement antennas covered by the Directive. Further thinking is required as to how to achieve this. TCAM 7 rediscussed |

| | |the matter and requested ADCO and RR11 to further study the issue (Action 7.3) and formulate a proposal for discussion in TCAM 8. Their |

| | |conclusions (TCAM 8 (01) 51) were endorsed by TCAM 8. |

| | | |

| | |Conclusion: |

| | |1 Antennas may be subdivided into "active" and "passive" types. In this categorisation, an "active" antenna is one that, as supplied, includes |

| | |one or more electronic components interacting with the signal. All other antennas are in principle considered "passive", irrespective of gain or |

| | |directional properties. |

| | |2 Active antennas are relevant components under Article 2(c) of the RTTE Directive, and thus are subject to the full requirements of the |

| | |Directive if placed on the market as a single commercial unit for distribution or final use. |

| | |3 Passive antennas are not considered as relevant components in their own right under Article 2(c) of the RTTE Directive, and thus fall outside |

| | |the scope of the RTTE Directive if placed on the market as a single commercial unit for distribution or final use. Passive antennas, if they are |

| | |marketed in conjunction with a radio product, will be subject to all the requirements of the Directive as part of the overall radio product. |

| | |4 Manufacturers who place on the market radio products without an antenna or with an antenna which is intended to allow replacement have a |

| | |responsibility to provide information on the general types and/or characteristics of antennas that may be used with their equipment in order that|

| | |the overall radio equipment will remain compliant. |

| | |5 Manufacturers of antennas are under an obligation, including through consumer laws, to ensure their products are fit for purpose. This requires|

| | |manufacturers, where the relevant ETSI harmonised standards include antenna requirements (for instance antenna radiation pattern for point to |

| | |point systems) or where the manufacturer of the intended radio equipment has provided information on the types and characteristics of antennas |

| | |suitable for his radio product, to ensure that these requirements are met. |

| | |6 Where a radio system is integrated on site - as for microwave point to point and point to multi-point systems - the system integrator is |

| | |responsible for ensuring compliance of the system with the Directive when the system is brought into service. |

| | |7 The above guidance takes into account that in practice there is a low risk of harm to people or of harmful interference resulting from the |

| | |separate sale of passive antennas, and that it would be disproportionate to consider them as relevant components. However, in exceptional cases, |

| | |TCAM can decide that an a priori passive antenna can nevertheless be treated as "active" when it is possible to identify a reasonable risk that |

| | |failure to meet the essential requirements of the Directive will result from its use. |

| | |In TCAM 17 the matter was again raised in the context of a specific standard. No discussion in TCAM 18, TCAM 19 concluded: |

| | |Noting that: |

| | |1) item 7 of the TCAM Guidance on antennas states “The above guidance takes into account that in practice there is a low risk of harm to people |

| | |or of harmful interference resulting from the separate sale of passive antennas, and that it would be disproportionate to consider them as |

| | |relevant components. However, in exceptional cases, TCAM can decide that an a priori passive antenna can nevertheless be treated as "active" when|

| | |it is possible to identify a reasonable risk that failure to meet the essential requirements of the Directive will result from its use.” |

| | |AND that: |

| | |2) draft ETSI EN 302 217-4-2 V1.1.2 “Fixed Radio Systems; Characteristics and requirements for point-to-point equipment and antennas; Part 4-2: |

| | |Harmonized EN covering essential requirements of Article 3.2 of R&TTE Directive for antennas” seeks to impose Article 3.2 requirements on |

| | |separately supplied antennas intended for use in fixed radio systems within the scope of the standard; |

| | |TCAM is of the opinion that there is a reasonable risk of failure to meet the essential requirements of the Directive if such antennas are not |

| | |considered “active” in the sense of the guidance and decides that: |

| | |separately supplied antennas intended for use in fixed radio systems within the scope of candidate harmonised standard ETSI EN 302 217-4-2 V1.1.2|

| | |are “relevant components” in the meaning of Directive 1999/5/EC and that the candidate harmonised standard should be prepared accordingly. |

|Is there a need for a manufacturer to have an | |Discussion concluded during TCAM 6. TCAM supported the analysis of the Commission that the manufacturer, when notifying doesn't need to have a |

|EU representative when notifying under | |representative in the EU. The issue was revisited in TCAM 18 and TCAM 19 agreed with a new analysis by the Commission. |

|article 6.4. | | |

|What is the relation of the R&TTE Directive | |Matter concluded in TCAM 7. Commission to formulate a mandate to have relevant harmonised standards under the medical devices Directives |

|with medical devices Directives | |recognised under the R&TTE Directive. |

|Can equipment, which is covered by the Marine | |Matter concluded in TCAM 7. Such equipment can be installed and operated (sometimes requiring a license) without additional assessment under the|

|Directive (96/98/EC), be installed on non-SOLAS| |R&TTE Directive. |

|ships or should such equipment in addition be | | |

|assessed to the R&TTE Directive? | | |

|Should a notified body number be on the | |Matter clarified in TCAM 7. The notified body number is an integral part of the marking and thus should appear on the packaging. |

|packaging? | | |

|Are their legal obligations for notification of| |Matter clarified in TCAM 7. Consumers, which buy equipment in another Member State and bring it in another Member State, don’t need to notify the|

|equipment crossing borders within the Community| |spectrum authority since they don’t place the product on the market. |

|What are the transitional arrangements of the | |Matter clarified in TCAM 7. Equipment placed on the market on 8 April 2001 could continue to be sold. In practice matters depend on the |

|Directive for EU and non-EU manufacturers | |ownership of the equipment on that date. Afterwards discussions developed on whether equipment owned by a manufacturer but which had left the |

| | |production phase could not be considered as been placed on the market. |

|What is the role of notified bodies on EMF and | |Matter clarified in TCAM 7. In the absence of Harmonised Standards the Directive foresees that Notified Bodies need to give an opinion on EMF. |

|can national regulations exist in addition to | |Member States can regulate, in conformance with article 7.2 of the Directive restrictions of use, e.g. by imposing minimum distances of base |

|the R&TTE Directive | |stations in order to ensure that exposure levels, such as recommended by the Council are respected. |

|Installations, extension of acquis under EMC | |Matter first discussed in TCAM 8. TCAM 9 set-up a ad hoc group for advice. Interim report in TCAM 10. Final report supported by delegations in|

|Directive to R&TTE Directive | |TCAM 11 to be forwarded for legal evaluation. In TCAM 12 delegations asked for detailed analysis by Commission, which was provided for TCAM 13. |

| | |Final guidance document for consultation in TCAM 14. TCAM14 supported that guidance. |

|Coverage of hand held radio devices operating | |Matter first discussed in TCAM 8. Discussion sent to ERC RR2 for advice. They recommended considering the products under discussion as |

|in the GMDSS by Decision 2000/638/EC | |non-compliant. During TCAM 9 UK indicated that they would allow the product on its national market. Commission considering the situation. |

| | |Discussion in TCAM 10, TCAM 11 and TCAM 12. Continued difference of opinion between UK and other Member States. Commission proposing a revision|

| | |of a Decision in TCAM 13. Issue resolved by a revision of the original GMDSS Decision. |

|How does the Directive apply to kits? | |Matter first discussed in TCAM 8. Matter was rediscussed in TCAM 9 on the basis of a proposed guideline from the Commission. Delegations |

| | |supported that proposal. Issue revisited in TCAM 11 with same conclusion. |

|What is the coverage of the Directive for | |Matter first discussed in TCAM 10 for a certain type of equipment. This demonstrated major divergences between Member States’ opinions. In TCAM|

|aeronautical equipment? | |11, the Commission informed about initiatives in DG TREN to resolve the issue. In TCAM 12 R&TTE CA mentioned continued problems with such |

| | |equipment. No discussion in TCAM13, update in TCAM 14, TCAM15 TCAM16 TCAM17 and TCAM 18. In TCAM 19 the matter was concluded. The Single Sky |

| | |Directive has as an effect that ground-based air traffic management equipment is covered by the R&TTE Directive. |

|How should equipment containing an R&TTE | |Matter first discussed in TCAM 10, where the Commission proposed a modus vivendi. |

|component be marked and labelled? | |The following guidance on the marking of equipment containing R&TTE components was supported for publication on the R&TTE website: |

| | |Equipment, which at the time of placing on the market contains as an integral part an R&TTE component, which is not intended to be removed by the|

| | |user, should be marked according to the R&TTE Directive. In addition in its user manual it should comply with the R&TTE Directive and e.g. |

| | |indicate geographic limitations of use; |

| | |Equipment, which provides for the capability that users insert R&TTE components, but in themselves are not covered by the R&TTE Directive (e.g. |

| | |lap top computers) should not be marked according the R&TTE Directive. |

|Should a manufacturer of class 1 equipment | |Issue first raised in TCAM 11. All delegations except Belgium supported an interpretation, that no information should be provided when there are|

|explicitly inform users, that there aren’t | |no restrictions of use. Issue rediscussed in TCAM 12. Commission promised a legal analysis for TCAM 13, where the matter was concluded with a |

|geographical restrictions of use | |statement from Belgium. They would not take legal action against products where such information would not appear. |

|Is R&TTE equipment intended for installation in| |Issue first raised in TCAM 11. There is double coverage for such equipment, which implies that there is a need for type approval for certain EMC|

|cars exempted from the 95/54/EEC Directive | |parameters on top of the assessment under the R&TTE Directive. Agreement that such is not desirable and Commission intends to address the matter|

| | |in the revision of Directive 95/54/EEC. Report on progress in TCAM 12. Commission Services called for a meeting with the industry associations |

| | |and called upon them to seek a compromise. On the basis of this compromise a proposal is under development to be agreed by Member States. TCAM |

| | |updated on situation in TCAM13, TCAM 14 and TCAM15. In TCAM 16 the Commission informed the meeting that a political agreement with Member States|

| | |had been reached. This agreement implies, that equipment, which is for installation in cars but not sold with the car, and which is not |

| | |affecting safety critical functions can be placed on the market under EMC or R&TTE Directive without the need for a type approval certificate |

| | |under a revised automotive EMC Directive. |

|Is it appropriate that user documentation is | |Issue raised and resolved in TCAM 11. |

|provided on media other then paper? | |It is allowed to place complex products intended for professional use on the market by giving instructions to users in an electronic format. The|

| | |principle of proportionality should be applied. Information needs to be made available on a medium which the users is capable to read. |

|Should safeguard measures against non-CE marked| |Issue first raised in TCAM 12. A literal interpretation of the text of the Directive seems to lead to the conclusion that such measures need to |

|equipment be notified? | |be notified and that the Commission should arrive at an opinion on them. Issue on agenda of TCAM 13. Analysis tabled for TCAM 15, where TCAM |

| | |agreed with the analysis of the Commission.. |

|Is measurement equipment covered by the R&TTE | |Issue raised in TCAM 14 that concluded that measurement equipment (i.e. equipment of which the intended use is not radio communications) should |

|Directive? | |continue to be covered by the Low Voltage and EMC Directives only. Regulating their use, where there would be a risk of interference, is a |

| | |national matter. A Member State isn’t obliged to set-up a licensing regime for such use.. |

|Can harmonised standards that have been | |Issue raised in TCAM 15 and clarified. Such standards don’t give presumption of conformity with the Directive. When used, the technical file |

|superseded by new standards be used to | |should demonstrate how the requirements of the Directive have been met. |

|demonstrate compliance with the Directive? | | |

|For which requirements can a standard define | |Issue raised in TCAM 15 and clarified. Essential radio test suites can only cover transmission requirements, if it is justified to assume, that |

|“essential radio test suites”? | |only by performing a standardised test, the manufacturer can reasonably demonstrate that he meets the technical requirement. ETSI guide 299 201 |

| | |gives adequate guidance to standardisation committees in this matter. |

|Coverage of Ship Security Alert Systems | |Issue raised in TCAM 16 and resolved in TCAM 17 with the following guidance: |

| | |Ship security alert systems that are exclusively used for this purpose could be exempted from the Directive by Member States. There is however |

| | |no obligation on Member States to do so. |

| | |Ship security alert systems that use communications devices that are also used for types of communication, that fall outside the activities |

| | |mentioned in article 1.5 cannot be exempted from the Directive. |

| | |. |

|Is acoustic shock covered by the Directive | |Issue raised in TCAM 17. No discussion in TCAM 18. Clarified in TCAM 19. Acoustic shock is covered by the Directive but there is no need to |

| | |develop harmonised standards for it, given the rare incidents with it. |

|Are cochlear implants covered by the Directive | |Issue raised in TCAM 17. Discussion in TCAM 18. TCAM 19 concluded that cochlear implants are NOT covered by the Directive. |

|Does the Directive apply to various smaller | |Issue raised in TCAM 18 and resolved in TCAM 19. The situation is very dispersed and it depends on the territory where the Directive exactly |

|jurisdictions, which are not part of the EU? | |applies. |

|Can MS require that the CE mark be put on all | |Issue raised in TCAM 18 and resolved in TCAM 19. |

|elements of the user information | | |

|What are the labelling requirements for very | |Issue raised in TCAM 18 and resolved in TCAM 19. Equipment should be labelled with batch serial number etc. If the equipment is small the same |

|small types of equipment? | |provisions apply as to the CE marking. With modern production techniques, it should not be a problem to print very small labelling. |

|How does the Directive relate to inland | |Issue raised in TCAM 19. Some discussion in TCAM 20, issue concluded in TCAM 21. |

|waterway | | |

|Are RFID Tags covered by the Directive | |Issue raised in TCAM 19. Some discussion in TCAM 20, issue concluded in TCAM 21. |

|Are GSM interceptors illegal under the | |Issue raised and resolved in TCAM 20. Some precision given in TCAM 21. |

|Directive | |Jammers themselves are illegal, see discussion in TCAM 11. |

|What are the effects of the new EMC Directive | |Issue clarified in TCAM 21. The parallel conformity assessment procedure to assess EMC requirements under the procedures of the EMC Directive |

|on the operation of the Directive? | |will disappear. |

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