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UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment
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Subsequent to our previous post regarding the CE Marking of surgical masks used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist Manufacturers in getting their products into the field.
The Medicines and Health products Regulatory Agency (MHRA) has issued guidance for Manufacturers seeking a derogation from carrying out the full conformity assessment process in the interests of public health.
The guidance invokes a derogation within the Medical Devices Directive allowing the Regulatory Authorities to take such action where the threat to human health warrants it.
Please be aware that this Derogation does not apply to PPE. Manufacturers of PPE seeking should read the guidance offered by the EU Commission and in particular this commission recommendation and the guidance offered by the Uk Government Any queries regarding placing PPE on the market should be directed to the UK Department of Business, Energy and industrial Strategy (BEIS).
Some Frequently Asked Questions regarding the supply of Medical Devices and PPE during the Coronavirus outbreak have been included below.
Is my face mask a Medical Device or PPE?
This depends on the intended use of the mask. If the intention is to protect the patient, the mask is a Medical Device; if the intention is to protect the wearer, it is PPE. the majority of face masks being currently used during the outbreak are PPE.
What certification should I look for when I am buying face masks?
There is no ‘certification’ as such; compliance is demonstrated by the manufacturer. You should look for a ‘Declaration of Conformity’ referencing the legislation as above. Medical Face Masks are classified as ‘Class I’ Medical Devices and as such do not require third party assessment. Face masks used as PPE are classified as Category II (Face masks) or Category III (Respiratory Protective Equipment (RPE)) and will require third party (Notified Body) assessment, the name of this Notified Body should be listed on the Declaration.
What Standards should I use to manufacture my face masks?
The applicable Standard will depend on the product itself; Medical face masks (visors) should conform to EN 14683. In terms of PPE, EN 166 applies to face masks, EN 149 applies to half face RPE and EN 136 applies to full face RPE. For body protection, EN 14126 applies to full body overalls. It is important to stress that Standards are not compulsory, however they do offer good confidence.
What do the current derogations mean to suppliers?
The current derogations ease pressure on the supply chain by allowing healthcare authorities to procure products which have not gone through the formal assessment. However they must still be fit for purpose and safe. The derogation puts the responsibility on the buyer to procure safe equipment.
How do I find a Notified Body for my face mask?
The derogation also puts an obligation on Notified Bodies to prioritise equipment required during the outbreak. Notified Bodies able to carry out assessments against the Medical Devices Directive can be found here and those able to carry out assessments against the PPE Regulations can be found here
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