Medical devices have been around for thousands of years. Neolithic dentists using drills made from flint heads were active in Pakistan 9000 years ago. Since those times, medical devices have greatly transformed the quality of our lives, facilitating the lengthening of our life span.
Regulation of medical devices is required to ensure that only devices that can be shown to be both safe and effective are allowed on to the market. According to the EU Medical Device Regulation (MDR), a medical device is:
‘Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used alone, or in combination, for human beings…’.
European Parliament and the Council of the European Union, 2017
The CE mark
Between 1993 and 2020 the regulation of medical devices in the UK required conformity assessment, resulting in a now very familiar ‘CE mark’ (Figure 1). This mark is recognised throughout the European Economic Area (consisting of the EU and three the four members (Iceland, Liechtenstein and Norway) of the European Free trade Association), as well as by Turkey. This marking allowed for the harmonisation of technical requirements, facilitating free movement of goods and removing national barriers to trade.
In a manner that we have come to expect from the EU, the letters ‘CE’ do not actually stand for any particular words as the member states could not agree on what the words would be—and in what language. There was agreement that the letters would not stand for anything, which incidentally leads to some confusion because many Chinese products are now branded with a ‘CE’ symbol, which stands for ‘China Export’, that looks remarkably similar to the EU conformity assessment symbol!
To achieve such a mark, manufacturers must use a ‘notified body’ such as the British Standards Institution (BSI). A Notified Body is designated by one of the member states to assess whether the devices conform with applicable essential technical requirements as published in either the European directives or regulations.
There are currently 27 such Notified Bodies that have achieved such designation (European Commission, 2022). These bodies are wholly independent entities, but their certification procedures are not uniform and there is a difference of degrees of experience among Notified Bodies. There has been the suggestion that manufacturers may shop around within Europe to use those Notified Bodies with the most lax operating standards. The recent move to the Medical Devices Regulation aims to counteract this by imposing joint assessments when Notified Bodies are designated by multiple member states and the Commission to drive consistency.
Notified Bodies have come under particular scrutiny following episodes such as the Poly Implant Prostheses (PIP) scandal. The French manufacturer of silicone gel breast implants had been using unapproved in-house manufactured industrial-grade, instead of medical-grade, silicone for most of its implants. Investigators brought criticism down on notified body TÜV Rheinland for issuing a certificate of quality for a production process that did not include the in-house industrial-grade silicone. However, TÜV stated that ‘its remit was to check the production process, not the content of the silicone’. In 2021 a French court found TÜV Rheinland negligent and partially liable for damages. The amount of damages has yet to be set, but is likely to be eye-wateringly large.
The need for confidence in device certification has resulted in further EU regulations. Such regulations also need to keep pace with scientific and technical developments. One key regulatory change resulting from the PIP scandal was for Notified Bodies to routinely conduct unannounced visits to manufacturing premises to increase the likelihood of detecting any suspicious activities.
Since the UK left the EU on 31 January 2020, new arrangements have had to come into place to allow for the continued regulation of devices to ensure that only safe and effective devices are placed on the UK market.
UKCA mark
The UK Conformity Assessment (UKCA) mark (Figure 1) therefore came into force on 1 January 2021. It is the new UK product marking that will be required for certain products being placed on the market in Great Britain (England, Wales and Scotland). The UKCA mark covers most products that previously required the CE mark. From 1 July 2023, CE marking will no longer be accepted on most new products placed on the market in Great Britain and the UKCA mark will be required instead.
CE marking will continue to be recognised in the UK until the end of June 2023 to allow businesses time to adjust to the new requirements. The government will introduce legislation so that the UKCA marking can be placed on a label affixed to the product or on a document accompanying the product until 31 December 2023. Most products that are currently covered under regulations and directives for CE marking will fall under the scope of UKCA marking.
First impressions
Consultation on the future regulation of medical devices in the UK was completed in November 2021 and provided a first glimpse of the direction the UK may be taking. First impressions suggest that the UK will align quite closely with the new European MDR, especially in the areas of device risk classification, more restricted use of equivalence, provision of more health professional and patient information such as Summary of Safety and Clinical Performance (SSCP) documents and Implant Cards, as well as increased post-market surveillance requirements.
There does, however, appear to be more appetite for further requirements on implantable devices, with suggested prohibited use of equivalence, more stringent pre-market requirements such as additional monitoring and patient follow-up through a specified initial launch period, controlled user access to implantable devices during launch and the possibility of collecting and sharing of information through national device registries.
Some devices (eg Class I) do not require an ‘approved’ or notified body, but can be ‘self-certified’ by a manufacturer. These devices include examples such as glasses, stethoscopes and wheelchairs. The circumstances for self-declaration of conformity for UKCA marking will be the same as for CE marking.
If a manufacturer wants to sell a product into both the EU and the UK, they will require both UKCA and CE marking. It is certainly possible to achieve and place both marks on a single product. The UKCA mark will not be recognised in the EU market. Products that require CE marking will still need a CE marking to be sold in the EU.
The issue of Northern Ireland has complicated many of the arrangements so far established with the EU. As it currently stands, the UKCA marking alone cannot be used for goods placed on the Northern Ireland market. These devices will require both a CE mark and a UK (NI) supplementary mark when approved by a UK approved body (Figure 1).
The technical requirements (‘essential requirements’) that devices must now meet for the UKCA mark—and the conformity assessment processes and standards that can be used to demonstrate conformity—are largely the same as they were for the CE marking. As time passes, it is quite possible that there will be a divergence between the CE and the UKCA requirements, as different requirements are added by each. Manufacturers may choose to only market their devices in one or other of the markets, rather than both as they have done previously.
BSI
BSI (Figure 1) was founded as the Engineering Standards Committee in London in 1901. It operates in 195 countries and has over 5000 employees. BSI was instrumental in the formation of ISO, the International Organization for Standardization, in 1947 and of its European equivalent, CEN, in 1961. With over 80 000 clients, it is one of the world's largest certification bodies. It was the world's first national standards body and is now the market leader in the USA, the world's biggest healthcare market.
BSI employs 10 internal clinicians who provide clinical oversight to the regulation of medical devices. This is part of an ever-expanding team since its inception in 2015 when BSI hired its first practising clinician. This was to ensure that direct clinical competence was involved in the decision-making process when granting certification and that this could be conducted internally rather than having to rely solely on external experts. As well as practising clinicians, BSI also employs a variety of clinically competent reviewers who previously worked as doctors, nurses, dentists and similar health professionals.
The increase in clinical personnel has mirrored the increase in scrutiny required on clinical evidence when applying for a CE mark, where the bar is being set ever higher.
Confidence
The regulation of medical devices must be tight enough to prevent dangerous (or useless) products being placed on the market, but not too restrictive that it hinders manufacturers from innovating. As the UK steers it own course in the future, it must ensure that these boundaries are kept and that the public, as well as medical and nursing staff, remain confident in the devices available to them.