PR Newswire: news distribution, targeting and monitoring

Medical Devices Affected by RoHS Directive From 2014

Share with Twitter Share with LinkedIn

REUTLINGEN, Germany, February 27, 2013 /PRNewswire/ --

- CE documentation and several years of document archiving will become obligatory

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

Contact and further information:
iPoint-systems gmbh

Katie Böhme
Ludwig-Erhard-Str. 52-56
D-72760 Reutlingen
Tel.: +49(7121)1-44-89-6-13
Fax: +49(7121)1-44-89-89

The press release is also available online at

SOURCE iPoint-systems gmbh

Journalists and Bloggers

Visit PR Newswire for Journalists for releases, photos and customised feeds just for media.

View and download archived video content distributed by MultiVu on The Digital Center.

Contact us now to find out how we can help you
Share with Twitter Share with LinkedIn

Get content for your website

Enhance your website's or blog's content with PR Newswire's customised real-time news feeds.
Start today.



Contact PR Newswire

Send us an email at or call us at +44 (0)20 7454 5382



Become a PR Newswire client

Request more information about PR Newswire products & services or call us at +44 (0)20 7454 5382


Regulatory News Search
  1. Products & Services
  2. Knowledge Centre
  3. Browse News Releases
  4. Meet the Media
  5. Contact PR Newswire