PPE, the MDR and EU 2016/425

James

Involved In Discussions
#1
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
 
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Philip B

Involved In Discussions
#3
Hi James, as a manufacturer of Class I devices presumably you already have either ISO 9001 or 13485? I'm sure either of these would be adequate as the basis for a QMS for your face masks but you will probably have to extend your scope of registration with your certification body. As they take months to do anything at the best of times I would open dialogue with them as soon as possible mentioning that it is Covid-19 related (they might expedite it for you). Also, the Office for Product Safety & Standards has re-issued document Personal Protective Equipment (PPE) Regulations OPSS PPE Legislation Guidance for Businesses and has guidance for manufacturing PPE in the current climate.
 

James

Involved In Discussions
#4
Hi James, as a manufacturer of Class I devices presumably you already have either ISO 9001 or 13485? I'm sure either of these would be adequate as the basis for a QMS for your face masks but you will probably have to extend your scope of registration with your certification body. As they take months to do anything at the best of times I would open dialogue with them as soon as possible mentioning that it is Covid-19 related (they might expedite it for you). Also, the Office for Product Safety & Standards has re-issued document Personal Protective Equipment (PPE) Regulations OPSS PPE Legislation Guidance for Businesses and has guidance for manufacturing PPE in the current climate.
Yes, we are an NHS organisation so we can apply a Health Institution Exemption to our devices. We can't do that with PPE. We also don't need a notified body or formal certification to meet the MHRA expectations, albeit we are working towards 13485 and will have it in place later this year. Temporary production of PPE isn't something we have time to prepare lots of documentation for. There is no guidance for 'legitimate' emergency supply, which is effectively what we want to produce internally.

Thanks

James
 
#5
Hello James,

I dont know if you have made any progress on this so far. But from my understanding PPE that would be used for protection against COVID-19 would fall under category 3 in and would require notified body approval. Any products that are being sold without CE mark have to be assessed and part of a purchase organized by the relevant Member State authorities provided that is ensured that such products are only available for the healthcare workers for the duration of the current health crisis and that they are not entering the regular distribution channels and made available to other users.
So how are you saying you dont require notified body? Could you please clarify?

Thanks.
 
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