Regulatory Open Forum

The post says, "for [a] harmonized standard it must be applied immediately after publication in the EUOJ". Is this true?

Under MDD and many other lists of harmonized standards there is a column "Date of cessation of presumption of conformity of superseded standard" which provides the end of the transition period.

The first list of MDR harmonized standards doesn't have that column. As I see it, it could be for two reasons. My expected reason is that, for the time a standard appears on the list there is no superseded standard, so the column would be blank, However, when a standard is superseded eventually, the column will reappear. My unexpected reason is a change in the approach from a transition period to immediate and overnight implementation.

The immediate and overnight approach applied to EN ISO 14971:2012. The reason given was that all manufactures already comply with the MDD, so the new version of the standard had no new information. It turned out that, for nearly all manufactures, the assumption did not hold.

The post says, "for [a] harmonized standard it must be applied immediately after publication in the EUOJ". Is this true?

Under MDD and many other lists of harmonized standards there is a column "Date of cessation of presumption of conformity of superseded standard" which provides the end of the transition period.

The first list of MDR harmonized standards doesn't have that column. As I see it, it could be for two reasons. My expected reason is that, for the time a standard appears on the list there is no superseded standard, so the column would be blank, However, when a standard is superseded eventually, the column will reappear. My unexpected reason is a change in the approach from a transition period to immediate and overnight implementation.

The immediate and overnight approach applied to EN ISO 14971:2012. The reason given was that all manufactures already comply with the MDD, so the new version of the standard had no new information. It turned out that, for nearly all manufactures, the assumption did not hold.

The post says, "for [a] harmonized standard it must be applied immediately after publication in the EUOJ". Is this true?

Under MDD and many other lists of harmonized standards there is a column "Date of cessation of presumption of conformity of superseded standard" which provides the end of the transition period.

The first list of MDR harmonized standards doesn't have that column. As I see it, it could be for two reasons. My expected reason is that, for the time a standard appears on the list there is no superseded standard, so the column would be blank, However, when a standard is superseded eventually, the column will reappear. My unexpected reason is a change in the approach from a transition period to immediate and overnight implementation.

The immediate and overnight approach applied to EN ISO 14971:2012. The reason given was that all manufactures already comply with the MDD, so the new version of the standard had no new information. It turned out that, for nearly all manufactures, the assumption did not hold.

The post says, "for [a] harmonized standard it must be applied immediately after publication in the EUOJ". Is this true?

Under MDD and many other lists of harmonized standards there is a column "Date of cessation of presumption of conformity of superseded standard" which provides the end of the transition period.

The first list of MDR harmonized standards doesn't have that column. As I see it, it could be for two reasons. My expected reason is that, for the time a standard appears on the list there is no superseded standard, so the column would be blank, However, when a standard is superseded eventually, the column will reappear. My unexpected reason is a change in the approach from a transition period to immediate and overnight implementation.

The immediate and overnight approach applied to EN ISO 14971:2012. The reason given was that all manufactures already comply with the MDD, so the new version of the standard had no new information. It turned out that, for nearly all manufactures, the assumption did not hold.