You may be able to get exemptions from certain regulations for your medical device during the pandemic. How you go about this depends on what you are manufacturing.
Today we’ll be looking at Ventilators, PPE and COVID-19 testing kits – there are specific guidance notes and routes to follow for these types of devices.
Are you manufacturing ventilators? If you meet the required specifications, you can then contact the Department of Health and Social Care (DHSC) on email@example.com for their approval – with this approval you can submit your application for exemption to the MHRA.
Personal Protective Equipment (PPE)
Manufacturing PPE? The Office for Product Safety and Standards (OPSS) is working with businesses and local authorities to identify where regulatory requirements are preventing them delivering the products needed by the public and NHS. There is detailed guidance covering a range of topics including: hand cleaning and sanitising products; PPE; face coverings and face visors.
There is also a Q&A document for manufacturers of COVID-19 PPE which gives more information on how you can meet the requirements.
Tests and testing kits for COVID-19
The MHRA have produced separate guidance for COVID-19 tests and testing kits including a specification.
Exemptions for all other kinds of medical device
If you manufacture other medical devices such as surgical (medical) face masks, examination or surgical gloves, you can send your application directly to the MHRA at firstname.lastname@example.org
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 you will need to 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 the product is used
- 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 standard – harmonised or other) and any study data you have.
MHRA will be granting any exemptions under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002.
Limited changes to use for medical devices
To create more flexibility for manufacturers and availability of medical devices, MHRA would not expect to receive a request for derogation of a CE-marked device where there is limited change to its intended use. For example, changing its use from ward use to include intensive care use. However, you should perform a risk assessment and contact your notified body for advice in the first instance.
How will your exemption applications be processed?
You might be asked for additional information once your application has been received.
MHRA expects to receive a high volume of applications for derogations.
They will prioritise applications based on the needs of the healthcare providers to increase the supply of critical devices and tests.