As noted in our previous overview article, it is vital that interested companies continue to monitor and strategically act on the rapidly changing government position on the regulation of specific medical supply product types in the context of COVID-19.
The UK authority responsible for overseeing medical devices, the Medicines and Healthcare Products Regulatory Agency (MHRA), have announced a series of relevant initiatives. Their guidance documents provide broad-ranging exemptions, but in very narrow and prescriptive circumstances. This approach tends to suggest a very targeted approach with a view to strategic public health goals. Based on several references to relevant regulation penalty provisions, non-compliant products, and the fact that some initiatives expressly seek out non-compliance, the documents also have a distinctly ‘no free for all’ undertone that strongly suggests straying outside the MHRA’s well-defined parameters will not be tolerated, at least without express consultation with the regulator.
Recent key developments for medical devices in the UK produced as COVID-19 supplies are:
- An exemption from CE-marking requirements for medical devices in limited circumstances. Applicants must continue to obtain relevant approval from the Department of Health and Social Care (DHSC), if required (such as for ventilators, see below for more on ‘Ventilators’). Applicants then email the MHRA to benefit from this exemption. Applicants will need to supply certain basic information to the MHRA – most notably justification for exemption and likely timeframe to obtain CE marking. Applicants will need to establish, through bench testing or testing under harmonized standards, that the products function as intended. Manufacturers simply changing the use of their pre-existing medical devices are expressly excused from having to apply for this exemption – but are advised to perform a risk assessment and contact their notified body. (See full guidance of 25 March 2020 here).
- A ‘regulatory check’ form for manufacturers of CE-marked professional use test kits to confirm their products can be placed on the market. The form runs to 3 pages and asks detailed questions, including: basic information and test information (notably confirmation of professional use); details of test taking steps and commercialisation plans (including proof of CE mark status and volume of proposed supply). Whilst information about testing is included in the form, the MHRA will not review any test data to ensure its suitability. The MHRA also dissuades the use of pharmacy-sold test kits and reiterates the fact supply of CE-marked home use tests is illegal currently. (See full guidance, of 25 March 2020, here).
- Development of comprehensive guidance specifically on ventilators and free access to relevant technical standards on ventilators. This very specific guidance is provided on the basis that ventilators are identified as medical devices central to COVID-19 patient care, and yet have extremely prescriptive technical requirements for efficacy. The 25 page document sets out in detail requirements for ‘minimally acceptable’ performance of ‘rapidly manufactured ventilator systems’. It covers discrete areas such as: ventilation; gas and electricity; infection control; monitoring and alarms; biological safety; software safety; testing and unknown uses (see full guidance of 20 March 2020, here).
- Guidance on regulatory status of gloves, face masks and antimicrobial hand sanitisers and reiteration of offence provisions under applicable regulatory regimes: The MHRA have outlined detailed considerations when deciding which regulatory regimes (medicines, medical devices, PPE, biocides or cosmetics) apply in respect of surgical masks, general masks, hand sanitisers and examination gloves, surgical gloves and PPE gloves. The document recognises the nuances in determining applicable regulatory regimes. The guidance emphasises the existence of offences for breaching medicines, medical devices and PPE regulations also. (See full guidance of 26 March 2020, here).
The MHRA have foreshadowed the fact they expect to receive a high volume of inquiries as well as applications under the CE-derogation and test kit application/form routes, and that they will be prioritising the same based on the needs of healthcare providers for supply of critical devices and tests. Companies should consider these factors when determining their own strategies for production and application, therefore.
We will keep you updated on future developments on this rapidly changing topic. The MHRA have so far foreshadowed the development of future guidance on COVID-19 specific test kit specifications.