EU Commision New Rules For Auditing by NBs

The EU Commision published “COMMISSION RECOMMENDATIONof 24 September 2013 on the audits and assessments performed by notified bodies.

This clarifies and strengthens the criteria for certifying (and auditing) notified bodies and the criteria that the notified bodies have to use in assessing companies and products.

The main changes are that the member states are required to do a joint assessment of a potential notified body with experts from the Commission and to carry out surveillance and monitoring of notified bodies. It also requires notified bodies to do unannounced factory audits which they were not allowed to do before (but the FDA

It also states “As publication of residual risks in the information given to the user does not reduce the risk, but publication of residual risks and warnings used as risk
control measure may be beneficial, have residual risks been correctly placed on IFUs or provided in training, and have manufacturers evaluated whether those warnings are effective…” This clarifies that although labeling cannot reduce risk labelling can still be used as risk control measures.

Need Your Input!

We have been researching where and when to hold our next 3-day 62304/FDA training course and we want your feedback!
1) Does the location in the US for a public course matter to you … for example, west coast (e.g., San Francisco area) vs. east coast (e.g., Boston)?
2) What locations do you prefer?
3) Would you prefer just the 3-day FDA/62034 course or to have the option of a full week 3-day course followed by cybersecurity 1-day, and a usability 1-day?
4) What other countries would you want to see our course offered publicly?
5) What are best two months of the year for the course?  What are the least favored (not workable) months?
Please respond by email to by Sep 25, 2019 if possible!

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