In this issue, topics include new EMC and LVD Directives for electrical equipment, a newly revised Blue Guide, as well as a reminder regarding recast RoHS (Restriction of Hazardous Substances) Directive (2011/65/EU) compliance for IVDs.
EMC Directive 2004/108/EC and LVD Directive 2006/95/EC Repealed
Yesterday, the European Commission repealed EMC Directive 2004/108/EC and LVD Directive 2006/95/EC, replacing them with new EMC Directive 2014/30/EU and LVD Directive 2014/35/EU. Declarations of Conformity for these Directives, along with the applicable technical documentation, should be updated accordingly. Note that medical devices and IVDs are excluded from compliance to the EMC and LVD Directives, as the MDD 93/42/EEC and IVDD 98/79/EC, respectively, are considered specific directives.
The new Directives align with the New Legislative Framework. Differences are not especially significant, but a few notable ones include:

  • Declarations of Conformity shall be translated into the language required by each member state where the device will be marketed;
  • Additional details regarding the roles of economic operators, such as manufacturers and Authorized Representatives, and market surveillance responsibilities are included;
  • The importer’s name and address must now appear on the label;
  • Manufacturers must now conduct a thorough risk assessment.

The European Commission offers a guidance document (PDF) on the transition from LVD Directive 2006/95/EC to the new LVD Directive 2014/35/EU on their website.
New Blue Guide Released
On 5 April, the European Commission released a new version of their Blue Guide guidance document on the implementation of the New Legislative Framework, including the MDD and IVDD. The new version includes revisions related to the following:

  • Online sales;
  • New Directives, such as the EMC and LVD Directives discussed above;
  • A clarification that products that are rented and not purchased are not considered to be re-placed on the market each time they are rented;
  • Guidance on revisions to Declarations of Conformity based on the repeal/replacement of Directives/regulations;
  • The acceptability of e-labeling.

Please note that as this is an extensive document, it is not possible to summarize all of the changes here.
Reminder: IVD RoHS Compliance Date Approaching
Emergo would like to remind all IVD manufacturers that are considered electrical and electronic equipment (EEE) that the deadline for compliance of such devices with the requirements of the recast RoHS Directive (2011/65/EU) is 22 July 2016.

As always, feel free to reach out to the team involved in the AR service at Atlantico with any questions that you may have. All vigilance related matters may be directed to mschulte@methodizeinc.com. We look forward to continuing to serve as your European Authorized Representative
[European Authorize Representative]

Jack Slovick President Methodize Inc P.O. Box 463 Nevis, MN 56467 763.639.0238 (cell) www.methodizeinc.com