The European Union Association of Notified Bodies (EUANB) met in December in Spain to discuss proposed revisions to the EMC Directive. The final revised Directive is expected to be issued in the next few months.
EUANB is the Notified Body Group for the EMC Directive and is composed of members who are a Notified Body (NB) in the EEA Countries or a Conformity Assessment Body (CAB) in a country where the EU has a mutual recognition agreement in place. MET Labs is an EMC Directive NB by virtue of a US-EU mutual recognition agreement (MRA).
The Commission has sent the revised document for discussion by the Council and EU Ministers, as well as by the EU Parliament. It is expected that the final revised EMC Directive will be published in the first quarter of 2013. There will then be a period during which each EU Member State will be transposing the Directive into national law. The latest available proposal contains a transition period of 2 years after the Directive has become operational.
In the revised EMC Directive, there are two modules made available to the manufacturer:
- Module A – Self certification, where the manufacturer determines compliance and issues its Declaration of Conformity (DoC)
- Modules B+C – Notified Body issues EU-Type Certificate (Module B), manufacturer then issues DoC (Module C)
A draft template for the EU‐Type Examination Certificate will be developed.
Much of the proposed changes center on a new role for Notified Bodies, as detailed following:
- The NB shall prepare an evaluation report explaining how compliance was determined.
- If documents are satisfactory, NB shall then issue an EU-Type Examination Certificate. An “opinion” is no longer being issued.
- If documents are not satisfactory, NB shall issue a letter of refusal.
- The manufacturer must choose a single NB and declare that no other NB has been used. This means that “NB Shopping” will not be allowed.
- The manufacturer specifies which parts of the Directive the NB is going to review, and the NB role is then limited to that aspect of the review.
- There is a new NB role that involves monitoring. Specifically, the NB must stay up‐to‐date with the “state of the art” and determine if the changes might impact the approved type. If so, they must contact the client manufacturer.
- The NB must inform the Notifying Authority (e.g. NIST for U.S. NBs) about issued or withdrawn certificates and periodically make available a list of the refused, suspended or otherwise restricted certificates to the Notifying Authority.
- There is a new requirement for information sharing with other NBs and with the Commission and market surveillance authorities.
- Record keeping – the NB shall keep the technical file and related documents for 10 years or until the EU‐Type Certificate is withdrawn.
The proposed date of the next meeting is Friday, May 3, 2013 in Amsterdam in conjunction with the R&TTECA meeting on May 2.
Questions about the proposed changes? Ask Pat, our regulatory compliance expert.
Credit: NIST provided much of the information provided in this post.