[MEET THE EXPERT] - Medical Cluster

Formal Objection against ISO standards and
potential consequences for MD manufacturers
Orlando R. Antunes, Thommen Medical AG, Waldenburg
INTRODUCTION: The principle of using
harmonized standards is as old as the “New
Approach” concept of the European Union.
Harmonized Standards are common used
instruments in order to achieve the presumption of
conformity and to prove compliance and
achievement of essential requirements given on the
directives.
On November 15 th 2010 the European
Commission issued a formal objection against
11 international recognized and harmonized
standards. The official explanation is that the
European Commission is concerned that these
standards do not sufficiently cover the essential
requirements of the applicable medical devices
directives that are claimed to be covered in the
standards' annexes Z. Among others standards, a
very important standard used by a broad range of
medical devices manufacturers (EN ISO
14971:2009 - Medical devices - Application of risk
management to medical devices) was included on
the list. Moreover, on February 10 th 2011, the
Swedish Competent Authority also submitted a
formal objection to another inalienable
standard. This time the EN ISO 13485:2003 –
Medical Devices - Quality Management systems -
Requirements for Regulatory Purposes was on the
focus of the international authorities.
These initiatives at European level could represent
an important challenge for the medical devices
industry if no consensus is found in a timely
manner. Moreover, it could also jeopardize the
entire concept of harmonized standards, which is
well implemented and adopted in Europe.
CONCEPTS: Since 1987 some 25 European
Directives have been adopted under the "New
Approach", according to which European
Standards are needed to "complete" each directive.
Among these directives, the directives covering
active and non-active implantable medical devices
(93/42/EEC, 90/385/EEC) as well as in vitro
diagnostic medical devices (98/79/EC) can be
found.
The New Approach is based on the following
principles:
� Essential health and safety requirements for
certain products requiring a particularly high
level of safety are defined in the directives.
� The corresponding technical specifications
giving detail to these essential requirements are
to be drawn up by the European Committees
(CEN, CENELEC and ETSI) in the form of
harmonized European Standards, following a
mandate issued by the European Commission
and/or the EFTA secretariat.
� These European Standards are to be adopted as
national standards in each EU and EFTA
member country. Standards are not
mandatory; rather, their use is voluntary. In
principle an alternative means of proving
compliance with the safety requirements of
the directives is possible.
The harmonized standards grant the presumption
of conformity to the essential requirements of
the new approach directives applied to that
standard. Detailed information on what requirements
of the directives are covered by the
standards is given on each harmonized standard on
their annexes ZA, ZB and ZC. The harmonization
comes into effect once these standards are listed
and published in the official gazette in relation
with the specified directive. An updated list about
references for every directive is available on:
http://ec.europa.eu/enterprise/policies/europeanstandards/documents/harmonised-standardslegislation/list-references/index_en.htm
DISCUSSION & CONCLUSIONS: The last developments
show that the European Commission is
willing to reconsider the deharmonization of the
standards, if the Z Annexes - after being amended -
provide accurate information about the coverage of
the Essential Requirements of the directives. The
key element for the Z Annexes is to indicate which
essential requirements or parts of essential requirements
are covered. The standards technical committees
involved are now working on the amendment
of these Annexes. At latest by mid 2011 the
new drafts should be submitted to the CEN-CEN-
ELEC Management Centre (CCMC) for adoption.
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