CE documentation and several years of document archiving will become
obligatory
REUTLINGEN, Germany, Feb. 27, 2013 /CNW/ - In addition to the Chemicals
Regulation REACH (Regulation concerning the Registration, Evaluation,
Authorisation and Restriction of Chemicals), medical devices will have
to comply with the European RoHS Directive on the restriction of the
use of certain hazardous substances in electrical and electronic
equipment in the future: As of July 22, 2014, RoHS (Restriction of
Hazardous Substances Directive) must be observed for first time
distribution of all medical devices to the full extent. Furthermore,
all products with a CE marking must also be RoHS-compliant. This means
considerably more work for manufacturers, suppliers and importers
regarding the documentation and monitoring of medical devices - for
instance, a continuous exchange of information in the entire supply
chain is required.
With RoHS, the European Union wants to optimize the manufacturing and
the respective recycling of the rapidly changing products in the
electronics industry. The RoHS-Recast Directive (2011/65/EU), in force
since 2011, now expressly includes medical devices. For example, a
technical documentation and the compulsory EU declaration of conformity
for proof of compliance must be prepared for every product and archived
for ten years. "If the additional tasks are not supported by a
professional and established software solution, there will be a
significantly increased personnel expenditure in any case", says Marek
Stachura, product manager for electronics and medical technology at
iPoint-systems, the world's leading software and consulting partner for
environmental product compliance and sustainability.
In case of suspected non-conformity, the competent authority will be
informed. This can lead to corrective measures or returns and recall.
Adaptive software solutions like iPoint's Compliance Agent ensure that
this does not happen: They are adjusted to the latest versions of the
respective directives currently in force and ensure automated and
secure exchange of relevant information across the entire supply chain.
Overview of banned substances:
-
Lead (0.1%)
-
Mercury (0.1%)
-
Cadmium (0.01%)
-
Hexavalent chromium (0.1%)
-
Polybrominated biphenyls (PBB) (0.1%)
-
Polybrominated diphenyl ethers (PBDE) (0.1%)
About iPoint-systems:
iPoint is the world's leading expert in environmental product compliance
and sustainability, focusing on software, consulting and training for
managing, tracking, and reporting across the whole supply chain, from
product concept over the production and use, to recycling and reuse.
iPoint delivers adaptive and comprehensive software solutions that give
the transparency and control customers seek in managing compliance and
sustainability. For more information, visit http://www.ipoint-systems.com
The press release is also available online at http://www.ipoint-systems.com
SOURCE: iPoint-systems Gmbh
