EN ISO 14971, “Medical devices – Application of risk management to medical devices,” and it’s Annex Z’s are continuing to give medical device manufacturers heartburn! At the root of the matter is the issue of the presumption of conformity — The concept that adherence to a harmonized EN standard provides the user with proof of conformance to the applicable Directive. With the issuance of the Z Annexes in 2012 for EN ISO 14971, gaps were revealed and this is causing doubt about the basic tenets of the New Approach from back in the 1990’s.
However, there are sources available that can shed some light on how to bridge the gap from the EN ISO 14971’s requirements to those of the 3 relevant European Directives (90/385/EEC, 93/42/EEC and 98/79/EC). One of the best documents I’ve found in recent months is the Team-NB’s Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971: 2012.
Team NB is the European Association for Medical devices of Notified Bodies, a group whose members are the Notified Bodies themselves. These organizations do the auditing for EN certification to the various directives, and in particular in this case, the medical device directives noted above.
As with all certification to the medical device directives, the gap exposed in the “presumption of conformity” by the amended Z Annexes in 2012 has caused a great deal of confusion among medical device companies. So Team-NB created a consensus paper to help shed light on what can reasonably be expected of medical device manufacturers needing to have product certified for sale in Europe.
This particular paper provides device makers with clean and concrete information on how to reconcile the language of EN ISO 14971 with that of the 3 directives. Additionally, it makes recommendations to auditors and to the standards bodies responsible for both ISO 14971 and IEC 60601-1.
For industry, there is information and recommendations for all 7 of the content deviations that have been brought to light by the latest edition of the 3 Z Annexes. This content deviations are:
- Treatment of negligible risks
- Discretionary power of manufacturers as to acceptability of risks
- Risk reduction “as far as possible” versus “as low as reasonably practicable”
- Discretion as to whether a risk-benefit analysis needs to take place
- Discretion as to the risk control options
- Deviation as to the first risk control option
- Information of the users influencing the residual risk
You’ll be pleased to know that there is an explanation of each deviation as well as specific actionable recommendations for each. Combined with the material in the first 3 Sections (Introduction, Terminology, and General Considerations), you will have a good understanding of what’s generated these issues and what you’ll need to do now that they have been raised.
Meantime, if you do not have the latest edition of EN ISO 14971, you’ll need to get a copy. The document is covered by copyright and must be purchased from an authorized dealer like Document Center Inc. It can only be purchased as a national edition since the EN documents are not published in any other format. Take a look at these three options offered by Document Center: SIS EN ISO 14971, BS EN ISO 14971, and DIN EN ISO 14971. All three are in English, so you’ll make your buying decision based on the formats available and the price. Remember: Document Center Inc. is your Standards Expert!
