The European Union (EU) has assembled regulations and decisions, known as the New Legislative Framework (NLF), with the primary tasks of improving market surveillance, improving the quality of conformity assessment, and providing a common legal framework for products. The NLF's accepted general rules are applicable to all New Approach directives, including the EMC Directive (EMCD) and the R&TTE Directive (R&TTED). In November of 2011, the EU commission issued an "Alignment Package" of 9 draft directives, which have changes to align with the requirements of the NLF. These drafts are currently in the approval process from the EU Council and Parliament.
On Wednesday, October 17; the European commission proposed an update to clarify and simplify the R&TTE Directive, with market surveillance serving as the central aim in strengthening the level of compliance. This update will help clarify the obligations of manufacturers, authorized representative, importers, and distributors; and align the text of the directive to the NLF. In addition, there will be some specific requirements added such as accessory interoperability and stipulations on software. A full review of the proposal can be downloaded from the Europa Lexicon.
The EMC Directive will see a similar proposal soon, as stated previously, it is in draft revision with the EU Council and Parliament for approval, which is projected for acceptance by the end of 2012. The only purpose for the revision to align the directive with the NLF, and no change of scope will be implemented; however, this alignment will require many small changes and even a few major changes. Some of these changes will include the how Notified Bodies (NB) are utilized in Conformity Assessment Procedures, new content requirements in technical documentation, the structure of the Declaration of Conformity (DoC), and market surveillance.
In addition, the new EU legislation intends to protect public interests; the protection of the consumer, worker, or the environment; and avoidance of electromagnetic compatibility by limiting disturbances. These new risk assessments are in addition to those for health and safety, and should be designated as serious or non-serious. The EU requires all member states to evaluate any product with which there is ample reason to believe a risk, or serious risk, is present. Also note, member states will take action against any non-compliance, irrespective of assessed risk level.
The Market Surveillance Authority of the Member State, upon reason, may request from the manufacturer a translation of applicable sections of any technical documentation into the language of the Member State. The translation of the requested technical documentation has a deadline up to, but not exceeding 30 days; this is unless an expediate deadline is required due to serious or immediate risk. Non-compliance with these requirements may result in the Market Surveillance Authority requiring the manufacturer to have testing performed at the expense of the manufacturer by a competent body of the Market Surveilance Authority's choosing, to ensure compliance with the essential requirements of the applicable directive.
It should also be noted that several member states have asked for a transition period of three years; however, the reccomendation of the EUANB that the new system be followed as soon as the new directive is operational, to reduce inconsistencies between Notified Bodies and the different Member States.
For further information, please refer to these sources:
Commission proposes to update radio equipment rules. (2012, October 17). Retrieved October 22, 2012, from Europa RAPID press release website: http://europa.eu/rapid/press-release_IP-12-1109_en.htm
Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of the harmonisation of the laws of the Member States relating to the making available on the market of radio equipment. (2012, October 17). Retrieved October 22, 2012, from website: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2012:0584:FIN:EN:PDF
Hooper, Nick (2012). R&TTECA Briefing for TCBC Workshop [PowerPoint slides]. Retrieved from TCBC website: http://www.tcbcouncil.org/displaycommon.cfm?an=1&subarticlenbr=6 Filename: 2012-10-11-04 RTTE CA briefing for TCBC.pdf
Coenraads, Jan (2012). Developments in EU EMC Regulation [PowerPoint slides]. Retrieved from TCBC website: http://www.tcbcouncil.org/displaycommon.cfm?an=1&subarticlenbr=6 Filename: 2012-10-11-04 TCBC Baltimore October 2012.pdf