The Radio and Telecommunications Terminal Equipment Compliance Association (R&TTE CA) met in December in Malaga, Spain to discuss proposed revisions to the R&TTE Directive, which is being renamed the Radio Equipment (RE) Directive.
At the meeting, MET Laboratories was approved as a R&TTE Compliance Association member. (This is unrelated to R&TTE Notified Body status – a designation that MET already had).
The European Commission issued a formal proposal for revisions to the Directive on October 17, 2012. The final revised legal text of the Directive is expected to be issued within 18 months, and then there will likely be an 18-month period during which each EU Member State will be transposing the Directive into national law.
The Directive was revised to align it with the New Legislative Framework (NLF) and to improve specific technical elements.
Key revisions contained in the proposal are as follows:
New Legislative Framework
NLF alignment issues will be common for all Directives:
- New responsibilities for manufacturers, authorized representatives, importers, and distributors
- Mandatory single Declaration of Conformity (DoC) issued by the manufacturer
- Requirements for the Technical Construction File (TCF)
- Translation of the TCF upon request
- Safeguard clauses and formal non-compliances
- Common DoC template
Specific Technical Changes
The proposed Directive also includes technical changes, some of which follow:
- Change to Scope
- Definition of Radio Equipment
- Provision for software-defined radio
- New registration scheme for radio equipment
- Extra information in user manual
- Simplified DoC allowed
- Geographic information in package
- Notified Body will only be required if there is no harmonized standard under Article 3.2
- NB ID is only needed under the Quality Assurance Module
- No notification of Member States with placement on the market
- Alert mark is formally required
- CE mark no longer required in the Manual – only on product and packaging
- For evaluation of Safety/EMC aspects, manufacturer has the following choices: OEM declaration, NB involvement and OEM Certificate to Type, or Full Quality Assurance Module by NB
- For evaluation of Radio aspects using full harmonized standards, manufacturer has the same 3 options. If not using full harmonized standards, OEM declaration is not allowed.
The proposed date of the next meeting is Thursday, May 2, 2013 in Amsterdam.
Questions about the proposed changes? Ask Pat, our regulatory compliance expert.
For product safety compliance engineers, note our upcoming complimentary webinars on Using the CB Scheme for International Product Safety Certification and North American Product Safety Certification for EU Manufacturers.
Many thanks to NIST, which provided much of the information provided in this post.