From 25 March, the MHRA is inviting medical device manufacturers to apply for fast-track approval of any medical device that can aid in tackling the COVID-19 pandemic.
In our earlier article, we discussed the MHRA’s announcement that it would fast-track the access to ventilators that meet minimum requirements, so that non-CE marked devices could be used by clinicians.
This new announcement goes a step further and stretches the possible exemptions to other medical devices, provided the aim is to use them in the fight against COVID-19. The guidance issued by the government states that these fast-track powers exist under the Medical Devices Regulations 2002 (UK MDR 2002).
The primary fast track route is under Regulation 12(5) UK MDR 2002, which states that the requirement (in Regulation 10) that any device placed on the market must be CE marked, shall not apply:
… where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised … the placing on the market or putting into service of a particular relevant device or relevant devices of a particular class or description without a CE marking, where appropriate subject to conditions (which are complied with), …
Regulations 26(3) and 39(2) UK MDR 2002 also apply. They are identical to Regulation 12(5) but apply to active implantable medical devices and in vitro diagnostic medical devices respectively.
In order to obtain an exemption, a manufacturer must send an application to the Department of Health and Social Care. However, a manufacturer seeking to supply face masks or surgical gloves, should contact the MHRA directly.
To add further flexibility, the MHRA stated that it does not expect to receive a derogation application for a CE marked device, where there is a limited change to its use. For example, changing the use of a device from ward use to intensive care use.
Recent encouragement to manufacturers by the MHRA to fast-track medical devices onto the market comes in the wake of the European Commission (Commission) issuing a Recommendation to that effect on 13 March 2020 (Recommendation). The Recommendation acknowledges the demand for personal protective equipment (PPE) and medical devices across the EU.
In an attempt to meet this demand, many manufacturers are:
- Redesigning supply chains;
- Launching new manufacturing lines; and
- Diversifying their supplier bases.
The Recommendation acknowledges the regulatory barriers which are created by the requirements for PPE, which are set out in Regulation 2016/425 (PPE Regulation), and the requirements for medical devices currently set out in the Medical Device Directive (MDD), which will soon be replaced when the Medical Device Regulations (EU MDR) come into force.
The Recommendation addresses two of the principal regulatory barriers to market for manufacturers of PPE and medical devices:
- Conformity assessments; and
- Market surveillance.
Article 8 of the PPE Regulation and Article 11 of the MDD require a conformity assessment on each product before it is placed on the market. The Recommendation states that due to the current health emergency, Member States should invoke the derogations in order to avoid needing to complete conformity assessments. The Recommendation states:
Derogations from conformity assessment procedures may be authorised by Member States, on duly justified request, for the placing on the market and putting into service, within the territory of the Member State concerned, of individual devices the use of which is in the interest of protection of health.
Further, if one Member State relaxes the requirements for a conformity assessment and approves a product through this mechanism, the Commission can make that approval mandatory across the EU using their powers under Article 59 EU MDR, further decreasing approval time.
The market surveillance provisions in the Recommendation address three points. First, the need for Member States to police non-compliant devices and equipment that have been placed on the market in response to the COVID-19 pandemic. This is so that a wide range of potentially unsafe devices and equipment do not flood the market in response to the pandemic.
Secondly, if, based on market surveillance data, a Member State is satisfied that non-CE marked PPE or medical devices display adequate health and safety in accordance with the essential requirements set out in the relevant legislation, then the Commission can issue a block exemption of all those product types, without them needing to pass a conformity assessment. This is a demonstration of Article 97(3) EU MDR and goes one step further than Article 59 by allowing for block exemptions.
Finally, PPE or medical devices that have not been CE marked may be assessed as part of a bulk purchase organised by the Member State’s authorities, which in the UK’s case would be the MHRA. This would only be permitted if the PPE and medical devices were only used by healthcare workers for the duration of the crisis, and were not made available to other users or put into ordinary distribution channels.
As we have seen, the Commission’s recommendation to lower the administrative burden to placing medical devices and PPE on the market is being embraced, as evidenced by the MHRA encouraging manufacturers to apply for exemptions. Hopefully this will allow vital medical devices and PPE to be placed in the hands of healthcare professionals imminently.