By James I. J. Green

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Abstract

A custom-made device is a medical device that is ‘intended for the sole use of a particular patient' made ‘in accordance with a written prescription'. In a dental setting, common examples of custom-made devices include crowns, dentures and orthodontic appliances. Until fairly recently, dental professionals who manufactured custom-made devices within the European Union (EU) were required to do so in accordance with Council Directive 93/42/EEC (Medical Devices Directive [MDD]), which was given effect in the United Kingdom (UK) by the Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]). The MDD has since been replaced by Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR]). However, the withdrawal of the UK from the EU, the coronavirus disease 2019 (COVID-19) pandemic and the implementation of the Ireland/Northern Ireland Protocol has led to different parts of the UK following different legislative frameworks. Dental professionals in Great Britain (England, Scotland and Wales) who manufacture custom-made devices must follow the relevant requirements of the UK MDR 2002 (although devices may be placed on the market in accordance with the EU MDR until 30 June 2024) whilst those in Northern Ireland are subject to the EU MDR. This paper provides answers to some key questions regarding the ways in which these legislative changes have impacted the provision of custom-made devices in the UK.

Introduction

A custom-made device is ‘intended for the sole use of a particular patient' made ‘in accordance with a written prescription' (see Table 1 for full definitions). Figure 1 provides examples of custom-made devices in a dental setting. Until 2021, custom-made devices manufactured within the European Union (EU) were governed by Council Directive 93/42/EEC (Medical Device Directive [MDD]).1 The MDD is given effect within the UK by The Medical Devices Regulations 2002 (Statutory Instrument 2002/618 [UK MDR 2002]).2

Table 1 Definitions given in medical device legislation that are pertinent to this paper
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Fig. 1
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Typical custom-made devices provided in a dental setting

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In the years that followed the implementation of the MDD, incidents with sub-standard devices outside dentistry led to the need for more robust requirements.3 On 5 April 2017, Regulation (EU) 2017/745 (Medical Device Regulation [EU MDR])4 was published and introduced significant changes to EU medical device legislation. The EU MDR came into force on 25 May 2017 and was scheduled to replace the MDD on 26 May 2020, but on 23 April 2020 full implementation was deferred by one year (until 26 May 2021) by Regulation (EU) 2020/561 as a result of the coronavirus disease 2019 (COVID-19) pandemic.5,6

On 1 April 2019, in preparation for the UK's departure from the EU, the EU MDR was effectively transposed into UK legislation by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (Statutory Instrument 2019/791 [UK MDR 2019]),7 an amendment of the UK MDR 2002, which was expected to take effect on the day the UK departed the EU.

The UK left the EU on 31 January 2020 and entered an 11-month implementation period (IP) the following day, during which EU legislation continued to apply in the UK.8 On 8 December 2020, the UK MDR 2002 was further amended by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2020, (Statutory Instrument 2020/1478 [UK MDR 2020]),9 which revoked the provisions of the EU MDR and substituted ‘exit day' for ‘IP completion day'. The IP ended on 31 December 2020.10

Despite the UK's departure from the EU, one of the UK's four constituent countries, Northern Ireland (NI), remains in line with the EU legislation due to the Ireland/Northern Ireland Protocol, which was designed to avoid a hard border between NI and the Republic of Ireland.11,12 Therefore, medical devices in Great Britain (GB) must conform to the relevant requirements of the UK MDR 2002 (as amended) while those manufactured in NI are subject to the EU MDR.13 Alternatively, medical devices in GB may be manufactured in accordance with the EU MDR until 30 June 2024 (rather than 30 June 2023 as previously stated).14

An article published in the British Dental Journal in 2021,15and republished in BDJ Team in 2022,16 provided answers to some key questions regarding the ways in which these legislative changes have impacted the provision of custom-made devices; this paper provides answers to a further ten questions concerning this topic.

1. What is the difference between an EU directive and an EU regulation?

The EU's constitutional basis is set out in treaties that establish their rules and objectives. These objectives are met by different types of legislative acts: regulations, directives, decisions, recommendations and opinions. A regulation automatically becomes law in all member states from the date that it is fully implemented. A directive sets requirements that must be met in all member states but does not dictate the means of achieving them and needs to be transposed into national law in each member state before it becomes enforceable. A decision only applies to certain individuals or organisations. Regulations, directives and decisions are binding; recommendations and opinions do not impose legislative obligations and are non-binding.

In the years that followed the implementation of the MDD, incidents with sub-standard devices outside dentistry led to the need for more robust requirements

In terms of UK medical device legislation, an EU Directive and an EU Regulation continue to have relevance. Following the UK's departure from the EU, the one-year deferment of the full implementation of the EU MDR due to COVID-19 and the implementation of the Ireland/Northern Ireland Protocol, GB follows an EU Directive (the MDD, given effect by the UK MDR 2002) whilst NI follows an EU Regulation (the EU MDR).

2. How does risk classification affect the legislative requirements for custom-made devices?

Under UK and EU legislation, medical devices are divided into four classes according to the potential level of risk associated with their use (I, IIa, IIb and III). Devices are categorised using classification rules, which are based on factors such as intended duration of use, intended purpose and invasiveness (Table 2). Some requirements for custom-made devices are driven by classification:

Table 2 Custom-made dental device classification under UK and EU medical device legislation
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  • Class I devices do not need to be provided with a statement17

  • Class I or IIa devices can be provided without instructions for use if they can be safely used without them1,4

  • Medical device manufacturers in NI and the EU are required to have a quality management system (QMS) ‘that is proportionate to the risk class and the type of device'. (EU MDR Article 10[9]): Class III custom-made implantable devices (such as dental implants with a biological effect) are subject to the conformity assessment set out in EU MDR Annex IX Chapter I or Annex XI Part A.4 In GB, following the government response to the consultation on the future regulation of medical devices, it is expected that custom-made device manufacturers will be required to have a QMS in place. The government considers that this QMS should be certified by a UK Approved Body in the case of Class IIb and Class III custom-made devices18

  • Medical device manufacturers in NI and the EU are required to prepare a Periodic Safety Update Report (PSUR) (EU MDR Article 86). The PSUR needs to be updated at least biennially for class IIa devices and annually for class IIb and class III devices. A similar requirement is expected to be introduced for GB manufacturers.18

3. What are the requirements of GB-based manufacturers who place custom-made devices on the NI or EU market?

Under the Ireland/Northern Ireland Protocol, a medical device moving from or through Great Britain to NI is considered to be an import into the EU.11 A GB-based manufacturer providing a medical device for a patient based in NI or the EU would constitute placing a medical device on the NI or EU market. Manufacturers outside the NI or EU who place a medical device on the NI or EU market must comply with the relevant requirements of the EU MDR and designate an Authorised Representative (as defined in Table 1) based in NI or the EU.13 The obligations of the Authorised Representative are set out in EU MDR Article 11 (Table 3).

Table 3 Obligations of the UK Responsible Person and the EU Authorised Representative
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4. What are the requirements of non-UK manufacturers who place custom-made devices on the GB market?

A medical device manufacturer that is based outside the UK who places medical devices on the GB market must appoint a UK Responsible Person (UKRP; definition given in Table 1).13 The UKRP is the UK equivalent of the EU Authorised Representative. A GB-based dentist who prescribes and fits a custom-made device that was constructed outside the UK may act as the UKRP for the overseas manufacturer. The obligations of the UKRP are set out in UK MDR 2002 regulation 7A(3) (Table 3).

5. Does a custom-made device prescriber need to be a healthcare professional?

Under the UK MDR 2002, a custom-made device must be ‘specifically made in accordance with a written prescription of a registered medical practitioner, or any other person authorised to write a prescription…' and under the EU MDR, a custom-made device must be ‘made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications…' This means that a custom-made device prescriber does not necessarily need to be a healthcare professional. However, in terms of UK dental professionals, only dentists can prescribe custom-made devices, except in the case of complete dentures, which can also be prescribed by clinical dental technicians.19

6. Do sports mouth guards fall within the jurisdiction of medical device legislation?

A sports mouth guard can be defined as ‘a resilient device or appliance placed inside the mouth (or inside and outside), to reduce mouth injuries, particularly to teeth and surrounding structures'.20 The Medicines and Healthcare products Regulatory Agency (MHRA) states that ‘mouth guards are only medical devices when intended for a specific ‘medical' purpose, for example as a retainer following orthodontic treatment or for use in the treatment of sleep apnoea or for bruxism. In most other cases these products will be PPE [personal protective equipment], including those intended for sports purposes.'21 Therefore, sports mouth guards are classed as PPE and are not governed by medical device legislation.

7. Do repairs to custom-made devices fall within the jurisdiction of medical device legislation?

The UK MDR 2002 defines ‘manufacturer' as ‘the person with responsibility for the design, manufacture, packaging and labelling of a device' or ‘who assembles, packages, processes, fully refurbishes or labels' a device (UK MDR 2002 Regulation 2) and the EU MDR states that ‘manufacturer' means a natural or legal person who manufactures or fully refurbishes a device...' (EU MDR Article 2[30]). As shown in Table 1, ‘fully refurbishing'… means the complete rebuilding of a device… or the making of a new device from used devices…' (EU MDR Article 2[30]). A custom-made device repair does not constitute ‘fully refurbishing' so is outside the scope of UK and EU medical device legislation.

8. Does medical device legislation make any stipulations regarding packaging for custom-made devices?

Custom-made devices in a dental setting are usually delivered in a non-sterile state. UK and EU legislation specify that packaging for non-sterile devices must maintain the integrity and cleanliness of the device. In cases where a device needs to be sterilised before use, such as arch bars and interocclusal wafers for orthognathic surgery facilitation, the packaging must minimise the risk of contamination from infectious material and also take the method of sterilisation into consideration (see Table 4).

Table 4 Packaging for non-sterile devices
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9. Does the Medicines and Medical Devices Act have any implications for manufacturers of custom-made devices?

A significant proportion of UK medical device regulations are currently derived from EU legislation. The Medicines and Medical Devices Act 2021 passed into law on 11 February 2021 and is an important step towards the UK devising its own legislation.22 The Act allows the amendment or supplementation of current human and veterinary medicine and medical device regulations (such as the UK MDR 2002). Medical devices are covered by Part 4 of the Act. The Act does not directly change the regulation of custom-made devices but allows the amendment of UK medical device legislation through secondary legislation (statutory instruments). Future statutory instruments, which have yet to be published, are expected to change the legislative requirements for custom-made devices.

Where a device needs to be sterilised before use, such as arch bars and interocclusal wafers, the packaging must minimise the risk of contamination and [consider] the method of sterilisation

10. What is the future expected to hold for the regulation of custom-made devices in the UK?

Between September and November 2021, the MHRA ran a consultation on proposed changes to UK medical device regulation, the government response to which was published on 26 June 2022.18 The UK government intends to introduce the following requirements for custom-made devices:

  • Clarification that the prescription for a custom-made device can be written in an electronic format

  • More enhanced Annex I requirements. All medical devices manufactured in Great Britain must conform to the relevant Essential Requirements set out in MDD Annex I (as modified by the UK MDR 2002) while those manufactured in NI need to comply with the General Safety and Performance Requirements (GSPRs) set out in EU MDR Annex I. The MDD Annex I and EU MDR Annex I requirements are largely comparable, but the latter have been expanded and include the obligation to establish, implement, document and maintain a risk management system. The government intends to broadly reflect the GSPRs in the UK regulations, tailored to a domestic context, and also introduce a requirement for manufacturers to list component parts or ingredients that are known allergens or sensitisers

  • The requirement for custom-made device manufacturers to implement a QMS, which should be certified by an Approved Body in the case of Class IIb and Class III custom-made devices

  • More detailed requirements for the technical documentation that must be drawn up and kept by custom-made device manufacturers

  • Enhanced post-market surveillance requirements: an obligation to produce periodic summary update reports or post-market surveillance reports. It is also expected that there will be a requirement for manufacturers to have measures in place, such as financial coverage, for providing recompense to those impacted by adverse incidents with medical devices.18

Conclusion

This paper intends to raise awareness of the changes to medical device regulations in the UK and the EU and answer some key questions regarding the ways in which these changes have affected the provision of custom-made devices. This paper is not intended to be a substitute for reading the legislation itself.

This article is based on a paper that was originally published as Medical device legislation for custom-made devices after the UK has left the EU: answers to a further ten important questions in the BDJ on 11 August 2023 (Volume 235, pages 205-210).