• The update of the list of harmonized standards under the 3 Directives is planned for the end of 2020.
• A new standardization request to CEN / CENELEC for harmonized standards under the Regulations is expected in the 1st quarter of 2021.
• Notified bodies cannot required the use of a certain version of a standard, but must check whether a standard (like any other technical solution) is correctly implemented by the manufacturer to comply with legal requirements.
• Manufacturers can choose between the use of a harmonized standard conferring the presumption of conformity, even if it is an old version, or a more recent standard which would represent “the state of the art “.
• The MDCG could prepare a guidance document to clarify the use of standards in relation to the regulatory obligation to take into account the state of the art (which is not a concept legally defined precisely).
• According to the work carried out by HAS (HArmonisation Standards), 3/4 of the standards produced by CEN / CENELEC cannot be “harmonized”.
For more information, see the minutes here: https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeetingDoc&docid=42283