Additive manufacturing could never have been foreseen under the Medical Device Regulations 2002. However, in particular use-cases, the regulations are friend not foe.
The Medical Device Regulations 2002 (link) are the longstanding body of legislation governing the regulation of all medical devices in the United Kingdom. It is the UK's implementation of EU decision 768/2008/EC that created the EU's common CE marking framework and allowed devices created in member states, to be sold in the single market and, due to recognition by 3 of the 4 EFTA states, the EU's Customs Union.
The regulations also create the Medicine's and Healthcare products Regulatory Agency's (MHRA) legal remit to assess clinical evidence and crucially, give record certification of medical devices into one of 4 difference classes (I, IIa, IIb and III). Class I, the least onerous for manufacturers must still bear a CE mark and is applicable to all manufacturers or authorised representatives of a manufacturer, who places such devices on the market, even for free.
Who Made This?
Identifying the manufacturer and authorised representative is crucial to this. Without that, the responsibility for regulatory approval cannot be determined.
The trouble with additive manufacturing is this muddies the water between the manufacturer, representative and client. Standards bodies like the BSI, who conduct conformity assessments for PPE conforming to EU 2016/425 and must include a quality system reference as part of that conformity assessment, like ISO 13485:2016. Anything beyond Class I requires an assessment which can take 6 to 12 months and cost up to £30,000 to implement. When trying to keep costs down for the NHS, and in an emergency scenario, this can be a huge risk to supply lines and is a large cost to bear.
During the 2020 Coronavirus pandemic, the call from the WHO in response to supply shortages caused by unprecedented demand and equipment hoarding, forced the European Commission to issue an embargo on medical devices conformance, to prevent delays getting adequate, but not medically assessed equipment to front-line workers. This was carried out in accordance with section 12 clause 5 of MDR2002, which had already foreseen the need to act in the event of emergency.
(5) Regulations 8 and 10 shall not apply where, following a duly justified request and in the interests of the protection of health, the Secretary of State has authorised, where appropriate for a specified period, 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), and has not withdrawn that authorisation.
From this, the short-term MHRA exemption followed.
However, inside section 12, is also a key, important clause that helps the healthcare additive manufacturing industry identify the manufacturer. Clause 2 on Custom made devices.
In-house Manufacturing
Within healthcare, the healthcare establishment and the additive manufacturer decide who the manufacturer is and who has full design control over the device. In some cases, the healthcare establishment can assume manufacturer or authorised representative for their own products in accordance with in-house manufacturing rules.
Key to this, is the fact those products are not propagated nor sold to another health establishment, even within the same foundation trust or care partnership and allowed Guy's and St Thomas' Hospital to create a 3D printing farm to manufacture face visors internally, and supply their own staff en-masse or of course, our own fleet in pharmacy and primary care.
These proved the use-cases work and demonstrated burst supplies are a viable way to ensure the NHS takes control of its supply chain using tools like Automedi to ensure they can function during an emergency. The Medical Device Regulations 2002 has proven itself as the conduit to that contingent supply. Can Public Health England afford not to consider it?