Exemption from the Regulation COVID-19 and QMS requirements

#1
We are currently looking to manufacture and sell Class I surgical face masks. At present we do not hold a 13485/9001 QMS system but have a GMP QMS for medicines. My question on this one would be whether we can CE mark the device (self certify) and use the current system we have in place (with additional requirements added to the system), or whether we will need to seek 13485 certification? We are looking to potentially apply under the exemption to the regulation for COVID-19 but I understand that this will restrict supply only to the NHS and we will not be able to distribute to the general public. We would like to supply to both as soon as possible.

Any advice on the best approach to this would be really appreciated.
 
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chris1price

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#2
Hi Laura, I am not familiar with the COVID exemption, however under normal circumstances, you would be expected to comply with the requirements of the MDD. You would be expected to have a quality system in place, it does not have to be certified to ISO13485, but should be equivalent. A pharmaceutical quality system will be very close, but I would recommend a gap assessment as there are requirements under ISO13485 that are different. For example, there are specific Management Review requirements that are not needed under cGMP.

The MDD does not specify what is needed from the quality system. However, if you look at Article 10 of the MDR, there is a list or requirements. It is probably worth starting from here, rather than having to repeat the exercise it in 6 months time.
 

dgrainger

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#3
Have a look at MHRA's guidance here: Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak

"How to apply to the MHRA
Send your application to [email protected].

Include the following information in your email:

  • for PPE/Protective MD applications only - Confirmation of whether the product is intended to protect the user, the patient or both
  • confirmation of the role of the applicant:
    • whether the applicant is the legal manufacturer for the medical device
    • if the manufacturer is outside of the UK please provide the Authorised Representative information
  • details of the product(s) (including model name, description and intended purpose of use)
  • impact in the context of the COVID-19 pandemic:
    • clinical justification for requesting an exemption from the regulations
    • evidence of demand for the device e.g. evidence of a purchase order/enquiries from NHS or government for you to supply
  • reasons why the product does not have a valid CE mark.
  • an essential requirements checklist demonstrating how the device meets appropriate standards. Where standards are not met a rationale/plan should be provided
  • evidence of ISO 13485 certification or equivalent
  • evidence of regulatory approval of the product within other jurisdictions e.g. FDA etc
  • explanation of any alternative CE marked products on the UK market and reasons why using these products would not be appropriate
  • numbers of product likely to be supplied under the exemption, plus an indication of how widely used the product is
  • expected time to gain/re-gain CE certification
  • instructions for use/labelling plus relevant marketing material
  • the clinical evidence base - clinical studies, literature etc
  • a detailed plan on how the manufacturer will demonstrate compliance or withdrawal of the device from the market after the temporary derogation expires.
You are expected to have evidence that the device performs as intended. For example, you should include performance data such as bench testing (including any that comply with a relevant standardharmonised or other) and any study data you have.

We will be granting any exemptions under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002."
 
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