Hello friends
I have suddenly been emerged into the world of PPE. We normally manufacture class 1 medical devices, but are temporarily manufacturing some face visors due to PPE shortages. From my understanding, items protecting the patient from the clinician fall under MDR, but if its protecting the clinician from the patient, its PPE?
I'm unsure what ISO standard would best apply to manufacturing under the 2016/425 regulation. We will be manufacturing simple disposable, single-use visors to be used during the Covid-19 pandemic only, but we want to ensure our processes are as compliant as possible with the Essential Health and Safety Requirements and other regulatory expectations.
Any guidance or information about relevant ISO systems for PPE manufacture would be appreciated
ALSO - Who regulates PPE in the UK? (Assuming the MHRA only regulates the PPE that fits the 'medical device' definition)
Regards
James
I have suddenly been emerged into the world of PPE. We normally manufacture class 1 medical devices, but are temporarily manufacturing some face visors due to PPE shortages. From my understanding, items protecting the patient from the clinician fall under MDR, but if its protecting the clinician from the patient, its PPE?
I'm unsure what ISO standard would best apply to manufacturing under the 2016/425 regulation. We will be manufacturing simple disposable, single-use visors to be used during the Covid-19 pandemic only, but we want to ensure our processes are as compliant as possible with the Essential Health and Safety Requirements and other regulatory expectations.
Any guidance or information about relevant ISO systems for PPE manufacture would be appreciated
ALSO - Who regulates PPE in the UK? (Assuming the MHRA only regulates the PPE that fits the 'medical device' definition)
Regards
James
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