Information Document 1-E
2 April 1997
Type approval is the process, through which the conformity of GMPCS equipment with regulatory technical requirements is assessed. These technical requirements are mainly intended to ensure that GMPCS products do not harm networks, other users or other equipment and a variety of procedures (ranging from obligatory third party testing towards manufacturers declaration) may be in place. Compliance with these requirements may be imposed in order to allow the product to be legally placed on the market or allow it to be legally used when temporarily admitted in a country, when the system within which it operates is allowed to offer service in that country. Authorities may accept type approvals from other countries for products to be sold and/or used.
In discussing an arrangement on the mutual recognition of type approvals, the following issues need to be addressed:
This document discusses how these issues are currently addressed within the EU and which agreements with third countries have been established. It concludes with a list of issues, which in our view need to be addressed in the Working Group dealing with type approval and marking.
The term essential requirements in the GMPCS MoU text has been derived from EU law on industrial products. What is essential depends on the actual product class and is defined in the product Directives. The essential requirements applicable to GMPCS Terminals in the EU are defined in the following EU Directives:
This Directive mainly covers normal electrical safety requirements. It however also includes health hazards caused by exposure of the human body to electromagnetic radiation.
CENELEC, a European Standardisation Organisation legally recognised by the EU and EFTA is in the process of drafting voluntary standards.
CENELEC and ETSI, another recognised European Standardisation Organisation are drafting standards laying down the requirements on GMPCS Terminals.
ETSI is in the process of preparing voluntary standards, which prepare the ground for the development of binding type approval regulations (Common Technical Regulations, CTRs) to be adopted in the 2nd half of 1997 under Directive 93/97/EEC. For existing systems, a number of CTRs are also under development.
Products complying with the requirements of these Directives carry the CE mark and can be freely placed on the market in all Member States and put into service. Actual usage of the product may be constrained by national licensing regimes. It should be noted that these Directives, where referring to standards, reference European Standards.
Any arrangement in the MoU needs to focus on a common definition of the essential requirements applicable to GMPCS equipment.
The Directives mentioned in the previous section lay down common conformity assessment procedures. For GMPCS terminals manufacturers declare compliance with the LVD requirements, whereas compliance with the requirements of the EMC and SES Directives is either done via 3rd party testing or certification of (part of) the manufacturing process.
A certificate issued under the Directives in any EU country is fully recognised in any EU country.
The CE mark must be affixed if a product meets the requirements of the applicable EU Directives. Given the fact that a number of Directives are applicable to GMPCS terminals, it would be a requirement for those terminals to carry the CE mark, in order to be legally placed on the market.
The European Economic Area (EEA) agreement between the EU and most of the EFTA countries foresees, amongst other things, full alignment of the legislation applicable to GMPCS terminals. There are no remaining barriers to trade in the EEA and type approved GMPCS terminals can be placed on the market in the whole EEA area.
In order to facilitate trade, negotiations on mutual recognition agreements (MRAs) of conformity assessment between the EU and third countries have been ongoing since a number of years. As regards the Directives applicable to GMPCS, agreements with Switzerland, the US, Canada, Australia and New Zealand have either been concluded or are about to be concluded. Negotiations with Japan are ongoing, whereas negotiations with other countries, notably in central Europe have been or are about to be started.
These MRAs foresee the possibility that type approval is done in the country of origin on the basis of the requirements of the destination market. Only in a limited amount of cases is alignment of the requirements within the scope of the agreement.
In general the MRAs do not deal with marking issues as the marking of the destination market is to be used. The agreements with Switzerland and the EEA countries foresee the usage of the CE mark.