What is the change in summary?
There is no change in the body text. The changes can be found in the “Z” Annexes: ZA – ZC. It is now clear which requirements must be met to satisfy the European Directives.
Note that the Z Annexes only apply if you are supplying into the EU Market – e.g. have a CE mark
- Annex ZA = Relationship between ISO 13485 and the EU Directive 90/385/EEC on Active Implantable Medical Devices
- Annex ZB = Relationship between ISO 13485 and the EU Directive 93/42/EEC on Medical Devices
- Annex C = Relationship between ISO 13485 and the EU Directive 98/79/EC on In-Vitro Diagnostic Devices
The tables contained in these Annexes indicate three options for each line item of the EU Directive;
Covered, with the ISO clause referenced
- Partial coverage, with the ISO clause referenced
- Not covered – this is where there is a complete gap between the EU Directive and the ISO 13485 standard
What is the Background?
The European standard EN ISO 13485:2012 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 24 January 2012. This replaces EN ISO 13485: 2003. The change was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problem, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.
It is important to note that the text of the global standard ISO 13485:2003 is unchanged. Only the foreword and annexes in the European version have been revised.
Once EN ISO 13485:2012 is harmonized there will be no need for existing customers with ISO 13485 certificates to undergo an automatic update or re-issue of certification. This is because there is no change in the requirements of the standard. Any existing certificates being renewed or reissued to support changes after this date will be updated at the point of reissue to also refer to ISO 13485:2012.