The display was classified as required by the MDD according to Annex IX of the directive and the medical device (MEDDEV) guidance available at the time of classification. Because the display uses electrical energy and has no direct patient connections and—by itself—no medical utility, the display is classified according to Rule 12 as an MDD Class I device, component, or accessory. The MDD states that manufacturers of Class I medical devices or accessories shall satisfy the requirements in regard to design and manufacturing controls, that is, the applicable assessment route to be used for CE-marking under the MDD, and it shall carry the CE mark according to Annex XII of the directive, with no notified body annotation.
The applicable safety standards for an MDD Class I display are IEC/EN
60601-1:1990 along with Amendments 1 and 2. To help the medical device designer evaluate the suitability of these displays, Planar has also conducted EMC testing to IEC 60601-1-2 as it can be applied. The display with its power supply alone does not represent a functional medical device. Hence, Planar configured a minimal operating system to exercise the display. The resulting data are made available to interested parties.
This is informative data, not certification data. Certification data must be obtained by the device or system integrator according to Article 12 of the MDD titled “Particular procedure for systems and procedure packs.” Paragraph 2 clearly outlines the device or system integrator’s responsibility in this matter.
In summary, Planar Systems, Inc. is CE-marking these displays under the Medical Device Directive, which establishes compliance to the basic medical safety standards. However, EMC compliance can only be accomplished in the configured medical device or system and is the responsibility of the device or system manufacturer. Planar has the necessary documentation such as IEC 60601-1 notified body and other third-party test reports and certifications, a risk/hazard analysis, an essential requirements checklist, and the Planar International Electrotechnical Commission (IEC) declaration of conformity.