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