Since the implementation of the “New Approach” and the CE Marking in the European Union, the requirements for device labeling have evolved, been reviewed, variously implemented and not uniformly enforced. A closer look at post-market compliance is an evolving trend across many economies. Discussions in the European Union, North America and the Asia-Pacific Economic Cooperation (APEC) continue to focus on post-market surveillance and enforcement. One area of scrutiny, particularly in Europe is device labeling.
Council Decision 768/2008, now in effect as of January 1, 2010, formerly implements what should have been done under the existing directive and related decisions. Enforcement and market surveillance has been, in a word, spotty. However, that does not mean the requirements of the directive (now given teeth by the decisions) were not in effect, it only means that not all surveillance agencies were geared up to implement the decision, or if geared up, did not do it. Manufacturers can expect that the ramp-up to full implementation might take sometime. However, it should be understood that it is in effect as of January 1, 2010 and some Member States will begin enforcement as of that date.
It would be wise for any manufacturer to make sure that they are, at this moment, in compliance with the new decision. Also, for example, 2001/95/EC (called the safety directive) and 93/465 have been in full implementation for quite some time now. If all of the requirements of the directives and decisions already in existence have been done, then the enforcement brought on by these decisions will not have great affect. If however, the directives and existing decisions have not been adequately followed and conformity to the essential requirements has not been adequately put in place, then you can expect some potentially serious issues beginning January 1, 2010.
Specific to the implementations are:
- 768/2008/EC decision from the Commission states the Member States are obligated to inform the Commission of their Penalty program no later than January 1, 2010. While not all Member States may actually do the in depth assessment/surveillance activities as other Member States, their penalty structure must still be in place January 1, 2010. Penalties can be assessed anytime after that.
- 339/93 (i.e. the old regulation dealing with surveillance etc) is repealed as of January 1, 2010 and thus the newer decisions (2008/768 and 2008/765) replace this regulation effective on that date. That does not mean however that some Member States will immediately begin to bring penalties. While some Member States may not begin to enact penalties immediately, that does not mean other more up to date Member States that already have strong surveillance activities will not. It would be wise to base placing a device on the market to the requirements of those ready to implement these activities and not base the whole of the EU surveillance program on those Member States not yet ready.
The reason is simple: on January 1, 2010, 93/465 is repealed and is replaced with decision 768/2008 (2008/768/EEC) dealing with the various CE marking modules. This means that as of January 1, 2010 the declaration of conformity and CE marking would have to meet the specifics of Annex III and Annex II of 2008/765 It should be noted that this is not new, as 93/465 had the same CE marking requirements. The only thing ‘new’ is the statement “If the CE marking is reduced or enlarged, the proportions given in the graduated drawing in paragraph 1 shall be respected.” This however, should have been, as we say, a ‘no brainer’ as it was always expected that if the CE marking was reduced in size per 93/465 it was to be directly proportionate to the sample marking in that decision. 2008/765 only makes this abundantly clear. Some Directives do already make this statement clear, such as the R&TTE Directive 1999/5/EC. If a CE Marking followed the pre-existing decision as expected, then this should be of no concern. If however, a responsible party did not follow the previous CE marking decisions, then as of January 1, 2010 they must comply so that all products placed on the market on or after January 1, 2010 would be as stated in 2008/765 and 2008/768.
It therefore would be unwise of a manufacturer to take a ‘wait and see’ position; rather, a review of the implementation of all aspects already in effect for the Directives should be carried out. It should be remembered that these two Commission Decisions are basically brought about because the requirements of the Directives already in effect are not being adequately met.
The bottom line is that only if a CE marking violated the existing 93/465 would there be any issues after January 1, 2010. Also, because of custom and legal implementation of the requirements into local regulatory activity, some Member States may begin enforcement before others.
Dennis Ward is the Director of Engineering at American TCB and may be contacted at firstname.lastname@example.org.