Risks to Health - Patient and Clinician



When defining the risks to health that may be associated with the use of a medical device does one generally also include those risks that the clinician may be exposed to? Interested in how others handle this. Thanks.


In US FDA jurisdiction, yes. FDA does not integrate well with PPE regulation, which is handled under different rules by a different agency with no cross-communications. FDA defines a number of purely-clinician-protecting product types as devices, i.e. surgical gowns, radiation vests/aprons/face shields/etc., and others.

In Europe, yes if you read the MDD literally. No, however, if you instead adopt the common view among some EU regulators that whatever it actually says, the MDD was only intended to apply to patients, and risks to and protection of clinicians instead fall under the PPE directive.

We make devices and PPE and have two NBs that have differing views on this question, and are subject to FDA jurisdiction and their viewpoint as well, so it's one that's dear to my heart. :rolleyes:


Note also from the introduction of 14971:

The particular complication of this is that some regulators don't consider some PPE (particularly that PPE which protects only the clinician, and not simultaneously the patient) to be a medical device, and 14971 is limited in applicability to medical devices.

It's a bit of a mess.
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