Amendment 1 to the Third Edition of EN60601-1 is harmonized under the Medical Device Directive (MDD)

Enews - 22 May 2014

EN 60601-1:2006/A1: 2013 has now been published in the Official Journal of the European Union, making it a harmonized standard under MDD 93/42/EEC. The cessation of the presumption of conformity for the 3rd Edition standard EN 60601-1: 2006 has been confirmed as 31 December 2017.

The Official Journal includes a note, that the Annex ZZ to EN 60601-1: 2006 ceases to specify the presumption of conformity with the Essential Requirements of the MDD on 31 December 2015. This means that from 1 January 2016, only the clauses and sub-clauses of EN 60601-1: 2006 corresponding with those referred to in Annex ZZ of EN 60601-1: 2006/A1: 2013 will provide presumption of conformity with the Essential Requirements of Directive 93/42/EEC to the extent indicated in Annex ZZ of EN 60601-1: 2006/A1: 2013.

Further details can be found at Europa Website.

Although there is a three year transition period for the 3rd Edition standard without the amendment, only the clauses of the standard that are contained in Annex ZZ of Amendment 1 will have a presumption of conformity from 1 January 2016.  Therefore, Annex ZZ of Amendment 1 should be given some consideration.

What will change in the third edition?

Amendment 1 has introduced 496 individual changes to the standard and these can be broadly divided into editorial/ clarifications or technical changes.

As with all harmonized standards, this standard is not compulsory. Compliance with the requirements of the MDD, including the Essential Requirements, must be established before CE marking is applied to a device. Harmonized standards are often an important part of the evidence to support MDD compliance.

How can BSI help?

Should you have any comments specifically relating to EN60601-1 or any further questions please contact your BSI Scheme Manager directly.

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Yours faithfully

David Adams

Manager of Active Devices

BSI Notified Body