The European Union does Mutual Recognition Agreements on a "per Directive"
basis, not
as the blurp says, on an "industry sector" basis. The "sectors" (read
Directives) involved
are to the best of my knowledge:
The Telecom (TTE) Directive
The Low Voltage Directive
The EMC Directive
The Recreational Craft Directive
The Medicinal Products/Drug GMP Directive (this includes 6 Directives and a
regulation and
the guides to Good Manufacturing Practice (GMP) and Good Distribution Practice
(GDP).
The Medical Devices Directives (medical devices and implanted medical devices).
You'all should have come to my seminars in Toronto and San Jose last year.
May do another one on the new CTE Directive, this fall.
Directives do NOT directly refer to particular standards but have it that the
equipment is presumed to comply with the essential requirements of the
Directive, if the requirements of an applicable "harmonized" standard are met.
If there are no harmonized standards in a particular discipline, than you're on
your own and probably in doodoo.
Annex III of the EMC Directive has imposed immunity requirements for years.
Nothing new
there. As new harmonized standards for immunity appear, that should make the
job of showing that you meet the esential requirements of the Directive, easier.
Please note that amending Directive 93/68/EEC deletes the 2nd dashed subclause
of
clause 11 in Directive 72/23/EEC, which called for the establishment of Notified
Bodies for Electrical Safety. It is unlikely that we'll have American Notified
Bodies for Electrical Safety, if there are no longer European ones. The
proposed new CTE Directive tends to relegate
Notified Bodies under that Directive, to keeping files that are passed on to
them for safe keeping. A much less conspicuous place. Conformity Assessment
Bodies in America
will think twice before they incur the expense of becoming some sort of pseudo
notified body
that has little to do. European Notified Bodies are already assessing the
situation and the nature of their business. They see much of their future in
advising their clients on what
needs to be done for specific markets, validating the choices made by product
management
and certify where necessary, but not necessarily certify.
Impact of the MRAs:
(1) From America to EU --
You continue to do Declarations of Conformity as you've always done, for
Electrical Safety and EMC. For Telecom, you're still having to get 3rd
party
testing, at least till the new CTE Directive becomes effective. However,
the
3rd party testing can be done by appropriately approved American labs.
American labs can also be used to produce the technical reports needed if
and when a Declaration of Conformity is challenged. Biggest boon is to be
that American labs can test to national requirements, where there are no
harmonized requirements. HOWEVER, some of these things are not currently
possible between member states. This will take some doing.
(2) From EU to America --
European manufacturers have always been able to supply test results to
American
authorities, on Telecom and EMC requirements. Recognition of the labs
never was
particularly onerous. We've seen already where the FCC has upped the ante
on EMC
lab recognition by requiring NIST accreditation (in case of Declaration of
Conformity).
The biggest gain for EU manufacturers is that they'll be able to do their
Electrical Safety
testing at home. The exact conditions need still to be worked out. One
issue is who
approves the European Labs. That one should be resolvable. Another one is
how one gets the Authorities having Jurisdiction to accept some 15 new
"marks" in North America.
That may be a much larger stumbling block.
Don't forget, as with the NAFTA, the initialing and signing of these
agreements is the BEGINNING of the real negotiations. The real
hard stuff on how to implement these
good intentions still has to come. 3 years after NAFTA became effective,
we still have
no way of getting our tests recognized in Mexico, although we're getting
there now.
Probably the biggest boon of these MRAs is that they force a reassessment
of the
current regulatory practices in the EU, the US and Canada, that hopefully
will lead
to doing away with unneeded procedures that add little or no value for
anyone in the
the foodchain.
Stay tuned, we're living in interesting times.
Ciao,
Vic Boersma
