FOI release

Freedom of Information request (FOI 22/740)

Published 17 January 2024

FOI 22/740

28th September 2022

Dear

Thank you for your email and we apologise for the delay in response to you.

Please find below answers to the questions you have raised in blue below.

Understanding regulatory requirements

1. The GDC suggest that the MHRA is the regulator for this part of dentistry. Can you confirm that in cases of suspected illegal activity involving dental devices or the Statement of Manufacture (SoM), patients and registrants should report it to the MHRA?

Are these complainants told the outcome of their complaint?

Whilst it is not a legal requirement under the UK Medical Device Regulations 2002 (as amended) to report suspected non-compliant or counterfeit medical devices to MHRA, we do encourage healthcare professionals and patients to report such devices where concerned, either by emailing [email protected] or via Yellow Card for suspected counterfeit devices. Complainants will not be updated on the outcome of the assessment or investigation, as this information is subject to confidentiality requirements set out in the Medicines and Medical Devices Act 2021, and can only be revealed under criminal procedure rules in a court case.

In addition, healthcare professionals and patients are encouraged to report any adverse incident (or near miss) with medical devices using Yellow Card.

The following link to our website provides guidance for how to report a non-compliant or suspected counterfeit medical device.

https://www.gov.uk/government/publications/report-a-non-compliant-medical-device-enforcement-process/report-a-non-compliant-or-suspected-counterfeit-medical-device

1. Would the MHRA agree that dental patients should be able to understand which devices they receive are under regulation and that they will be offered the SoM with their device, and which devices are not?

Manufacturers of all general custom-made devices are required to draw up a “custom-made statement”, as per the procedures in Part II of the UK MDR 2002, Annex VIII (as modified by Part II of Schedule 2A to the UK MDR 2002). For all but the lowest risk (Class I) devices, the manufacturer is required to provide the statement with the device, and the statement shall be available to the patient. As noted in MHRA guidance on custom-made device statements (https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948287/Examples_of_custom_made_statements_Dec2020.pdf), the dentist who prescribes and fits the appliance will be the ‘health professional’ responsible for making the patient aware of the availability of the statement and supplying it on request.  

1. Most dental device manufacturers are not experts in dental device regulation. Would the MHRA agree that as the competent authority, it is for the MHRA to give ‘clear’ guidance as to what a functional custom-made dental device is and who needs to register with the MHRA and follow manufacturing requirements?

Products which meet the legal definition of a medical device laid out in Regulation 2(1) of the UK Medical Devices Regulations 2002 (as amended) will be considered to be medical devices falling under the scope of UK MDR 2002. If these also meet the definition of “custom-made medical device” laid out in the legislation, then they will be considered custom-made medical devices. MHRA has produced guidance on the definition of a custom-made medical device with illustrative examples to assist manufacturers in determining whether their product falls under the scope of the UK MDR 2002 (as amended). The guidance also covers the requirements custom-made medical devices must meet to comply with the legislation. The guidance can be found at https://www.gov.uk/government/publications/custom-made-medical-devices/custom-made-devices-in-great-britain with examples of statements at https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948287/Examples_of_custom_made_statements_Dec2020.pdf.

Responses to questions:

1. GDC registrants are told they have a duty to report illegal activity under GDC standards. Does the MHRA agree that the MHRA must make it clear to manufacturers and dentists what is legally required and what represents illegal activity in regard to making and fitting dental devices?

2. Assuming that there may be a link between fitting illegally manufactured devices to patients and poor dentistry, would the MHRA disagree that in order to maintain confidence in regulation and provide moral hazard for those that choose to break the law, the MHRA should disclose what sanctions it gives to those that choose to break the law?

3. Does the MHRA publish details of cases when it has discovered illegal activity and reached a finding?

4. The MHRA says it will “assess all allegations of non compliance brought to us, using a risk-based system”. With the exception of the fitting of illegally manufactured implants the examples I give below may be low risk compared with say, counterfeit drugs, but ‘are’ poor dentistry. It is the GDC’s duty to regulate poor dentistry. No patients would want to have illegally manufactured dental devices fitted to them. Would the MHRA agree that between them the GDC and MHRA should have a way of regulating that stops it from happening?

MHRA is responsible for ensuring medical devices meet applicable standards of safety, quality and efficacy.  Manufacturers of medical devices are responsible for ensuring they understand and comply with the regulatory requirements applicable to their device.  There is a range of guidance documents available on the gov.uk website as well as guidance MEDDEVs and designated standards that may help manufacturers understand the regulatory requirements regarding medical devices. Manufacturers are encouraged to seek the views of their own professional advisors and can  also contact MHRA for general advice and guidance.

Chapter 4 of the Medicines and Medical Devices Act 2021 sets out the circumstances in which MHRA (acting on behalf of the Secretary of State) may and may not disclose information.  For example, whilst we may disclose information for the purposes of warning members of the public about concerns regarding the safety of a medical device, we cannot disclose commercially sensitive information where we do not consider it necessary to do so and where the disclosure may not be proportionate to what is sought to be achieved by it.  Therefore, we are not able to disclose details of investigations or outcomes unless we are satisfied that the disclosure is necessary and proportionate.

We acknowledge that even with the most stringent regulatory processes and oversight, there will always be allegations and incidences of non-compliant medical devices.  It would not be possible for MHRA to fully investigate every referral it receives, therefore, we operate a risk-based system to assess  allegations and balance the volume of referrals against available resources.  This system takes into consideration the potential hazards associated with the alleged non-compliance and the degree of perceived potential harm as well as the severity and probability that the alleged non-compliance will result in harm.  This gives us an overall risk rating for each allegation (‘low risk’, ‘significant risk’, ‘high risk’ and ‘serious risk’). 

We assess each allegation on a case-by-case basis and use the risk-based approach to prioritise allegations which pose a higher risk to public health.  That is not to say we won’t investigate allegations assigned a ‘low risk’ rating; we continuously review all reports and intelligence and where resources allow, we can open compliance investigations.

MHRA is committed to strengthening our partnership working across the UK, Europe and globally.  In the UK, we work closely with various other government departments, regulatory bodies, trade associations and health care bodies, however, we recognise the importance of building stronger partnerships and enhancing our public health impact through greater collaboration and engagement.  You can read more about our goals as an Agency in our Delivery Plan 2021-2023.

1. Can patients expect to see the manufacturer named on their SoM listed on the MHRA’s online database? (Subject to time for new registration processing)

MHRA would expect the manufacturer details used on the custom-made statement to be the same as the manufacturer’s MHRA registration details.

1. Are the MHRA aware of any classes of GDC registrants that are exempt from complying with manufacturing regulations?

2. Are the MHRA aware of any types of functional custom made dental devices that may be made without registering with the MHRA and complying with manufacturing regulations?

3. Regarding the attached letter from the EU commission. They have said “Dentists and dental technicians are manufacturers when they fulfil the definition of “manufacturer” in Article 2(30)’. Read in conjunction with Article 5(1) and Article 2(27)(28)(29), the expression “markets that device” must be understood as encompassing both the “placing on the market” of devices and/or “the putting into service” of devices not previously placed on the market.” And that dentists who mill a device out of a block of material and not adapting it because ““Mass-produced devices which need to be adapted to meet the specific requirements of any professional user” are devices which as such can already be used for medical purposes, but still need to be adapted to the patient in question following specific requirements of a professional user. This is not the case with raw material blocks. The blocks as such cannot be used as medical device. We would regard them rather as raw material for the manufacturing of a medical device.” Does the MHRA agree with the EU commission’s legal adviser’s explanation that dentists who make devices using CAD/CAM machines are not exempt from complying with MDR requirements?  If not, please can you say why?

I note your references to a letter from the EU commission and articles within the EU Medical Devices Regulations (EU MDR).  Please note that these regulations are not applicable in Great Britain (England, Scotland and Wales).  The applicable legislation is the Medical Devices Regulations 2002 (as amended) (UK MDR).  The UK MDR defines a ‘manufacturer’ as:

a) the person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party; or

b) any other person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name, apart from a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.

Therefore, if a dentist or dental technician designs and produces a dental device using raw materials, regardless of the method of production, it is likely they will meet the definition of a ‘manufacturer’ and must meet the relevant regulatory requirements in relation to that device.

All medical devices, including custom-made dental devices, must be registered with the MHRA

The role of the Statement of Manufacture in preventing illegal dentistry.

I understand that the requirements regarding the statement of manufacture are -

(5A) When a custom-made device is supplied to a patient, the healthcare professional who writes the prescription for the custom-made device shall, in relation to each patient that they supply with such a device—

(a) ensure that the patient is aware that they may request the statement containing the information required by Sections 1 and 2 of Annex VIII; and

(b) ensure that the statement containing the information required by Sections 1 and 2 of Annex VIII is made available to the patient on request.

1. Please can you confirm that this is the current wording?

Yes this wording is correct and can be found in the MDR 2002

The GDC have released guidance to those that provide dental devices to patients saying -

‘You must inform patients of the existence of the statement and offer them a copy. You must record whether or not they choose to take a copy of it. If the patient does not choose to take a copy of the statement, you must keep the statement for the lifetime of the device in case it is requested at a later date’

The GDC have released guidance to patients saying –

‘The person who prescribes your treatment (usually your dentist) must offer you a statement of manufacture with full details of the appliance. The statement is like a certificate or warranty, and proves that your device has been made to legal standards especially for you.’

The guidance means that if ever there is doubt over whether the Statement of Manufacture has not been made available or deliberately withheld from a patient for some reason, there is a written record of whether the patient has been made aware of their right to their information.

1. Does the MHRA agree with this mechanism to ensure the law has not been broken and the statement has not been withheld? If it does not, can you please explain the mechanism the MHRA uses in cases where it is in doubt? (For instance, where the device is illegally manufactured and a statement has not been made, or the gold alloy example case below. All members of the dental team will need to be aware of this.)

As stated in the regulations the healthcare professional is required to inform the patient that they may request the statement of manufacture and provide it to them if requested. If the statement has not been offered to the patient or does not exist then it would be a breach of the MDR 2002 and could lead to compliance action. Details on  compliance action can be found here.

What is illegal activity and how is it regulated? Example situations.

These examples do not refer directly to any of the cases that have been reported to the MHRA or GDC.

1. A manufacturer is making custom made functional dental devices to retain patients’ teeth. The manufacturer has not registered with the MHRA. They do not follow any of the manufacturing requirements or make a statement of manufacture for the devices they make.  A dentist chooses to use the manufacturer. When a device is fitted to a child the device cuts the child’s gums, which then bleed because it has not been made properly. The dentist does not make the SoM available for the patient (one was not made) or made the patient aware of their right to have their statement, offer or give it to them.

2. Has the law been broken? (Please can you explain why)
3. If this was reported to the MHRA would you come to a regulatory finding?
4. What sanctions would be given?
5. Would the MHRA make the GDC and CQC aware of the regulatory finding?

6. Would details of the case be published?

7. A patient asks a dentist for a gold crown. The dentist asks a manufacturer to make the crown out of copper/aluminium alloy (a very low-cost metal that is not approved for use in the NHS). The manufacturer makes one and correctly states the alloy used on the patient’s Statement of Manufacture. The patient is not made aware by the dentist of their right to have their statement of manufacture, offered it or given it. (This issue has been discussed on the BBC.)

8. Has the law been broken?
9. Please can you explain why?
10. If this was reported to the MHRA would you come to a regulatory finding?
11. If so, how?
12. What sanctions would be given?
13. Would the MHRA make the GDC aware of the regulatory finding?

14. Would details of the case be published?

15. A manufacturer makes a functional, custom-made dental device for a patient using a CAD/CAM machine. The manufacturer is not registered with the MHRA. They are not complying with manufacturing requirements. When a device from this manufacturer is fitted, the patient is not made aware of their right to have their statement, have it offered to them or made aware of their right to have it.  An incident with this patient leads to a GDC fitness to practice case where the GDC find that the dentist “provided a poorly fitting crown”.

16. Should the manufacturer have been registered with the MHRA?
17. Did the dentist act legally?
18. Has the law been broken?
19. If so, please can you explain why?
20. Would the MHRA expect the GDC to report it to the MHRA if they became aware of these details?
21. If this was reported to the MHRA would you come to a regulatory finding?
22. If so, how?
23. What sanctions would be given?

24. Would the MHRA make the GDC aware of the regulatory finding?

25. The MHRA is made aware of an illegal importer of custom-made dental implants (I believe the MHRA has disclosed knowledge of illegal importation of this type in a freedom of information answer).

26. Do the MHRA come to a regulatory finding in these cases?
27. If so, how?
28. What sanctions are given?
29. Given that these devices will be fitted by GDC and CQC registrants, do the MHRA make the GDC and CQC aware of the regulatory finding?
30. Would details of the case be published?

In the example situations given, there is evidence of breaches in the UK Medical Device Regulations 2002, which in turn are transposed to offences under safety regulations such as the Consumer Protection Act 1987. MHRA investigate allegations of regulatory breaches and the specific actions taken are determined on a case-by-case basis of our findings in each investigation or risk assessment.

MHRA investigations typically focus on bringing parties found to have breached the regulations into compliance with the requirements and their obligations. If parties fail to cooperate or there is a serious risk to public health MHRA may consider utilising enforcement powers, such as legal notices prohibiting the supply of medical devices or compelling them to undertake certain actions in the interest of patient safety. In cases where MHRA consider that a serious offence has been committed by failing to comply with the regulations or a legal notice, the parties involved may be subject to prosecution which can carry a penalty of an unlimited fine and/or 6 months imprisonment. Further information on our enforcement of the regulations can be read on our webpage linked here.

MHRA do not provide updates or outcomes on our investigations to complainants, nor do we publish our investigatory summaries or findings upon conclusion of our investigations. Details from an MHRA investigation may be published where it has progressed to public prosecution. We may notify or share information from our investigatory findings with relevant stakeholders, such as the NHS, GDC, or CQC where necessary, however this is also determined on a case-by-case basis.

Education

1. Can a manufacturer of custom-made dental devices based in a dental hospital choose not to register with the MHRA and comply with manufacturing requirements including not making a statement of manufacture for the patient?

Please review the following link of our website page below.

In-house manufacture of medical devices in Great Britain - GOV.UK (www.gov.uk)

1. Can a dentist in a dental hospital choose not to make the statement of manufacture ‘available’ to their patients and make the patient aware of their right to have their statement, offer it to them or give it to them? 

2. If manufacturers and dentists in dental hospitals can choose not to implement the MDR, would this be legal for their students not to comply when they leave the dental hospital?

3. If the MHRA and GDC allow dental hospitals to act in a way that would be illegal outside in regard to making and fitting of dental devices, how would the MHRA respond to a suggestion that allowing dental hospitals to claim health institution exemption from the MDR for custom made dental devices conflicts with the GDC’s duty to educate and could be considered to be ‘teaching illegal practice’?

4. Is the MHRA aware of any impediment that would stop manufacturers and dentists in dental teaching hospitals from following the same legal requirements as outside the dental hospital?

5. Does the dental hospital claiming exemption have to notify the MHRA?

6. If the MHRA is aware of policy that allows dental teaching hospitals to claim institutional exemption then under the freedom of information act please could I request the following information.

A. Information that would identify which organisation/s identified the need for the exemption, why they thought it was needed and when this was.

B.  If a consultation was held, the discussion document giving the points for discussion and which stake holders were consulted.

C. The finished policy.

As stated in the regulations, any custom made medical device that is manufactured and placed onto the UK market has a number of requirements that must be met. The manufacturer must be registered with MHRA, or have a UK Responsible Person registered with MHRA on their behalf (if the manufacturer is based outside of the UK). The manufacturer must also inform the patient of the devices statement of manufacture and produce and provide if requested a statement of manufacture to the patient.

If a device is manufactured and used on a patient within the UK then MHRA will expect the previous action to be undertaken and if they are not the manufacturer and/or the UK Responsible Person would be in breach of the Medical Device Regulations 2002 and could face compliance or enforcement action.  Details on compliance action can be found here

MHRA does not require a formal notification or application to manufacture under the in-house exemption in Great Britain and therefore do not hold this information for GB-based institutions applying the exemption.

Please review the guidance published online at the following link of our website page below:

https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices

We believe there may have been a mix up with the public consultation on the future medical devices regime however please let us know if this is the case.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/948827/Health_institution_exemption.pdf

Risk

1. If someone said it was ‘safe’ for a dentist to fit illegally manufactured or imported custom made dental devices to patients how would the MHRA respond?

Any medical devices used within the UK need to meet the requirements of the MDR 2002, if they do not then the manufacturer would be in breach of the regulations and the healthcare professional would also be in breach for putting into service an illegal device. Details on  compliance action can be found here

1. If someone said it was ‘acceptable’ for a dentist to fit illegally manufactured or imported custom made dental device to patients how would the MHRA respond?

Any medical devices used within the UK need to meet the requirements of the MDR 2002, if they do not then the manufacturer would be in breach of the regulations and the healthcare professional would also be in breach for putting into service an illegal device. Details on  compliance action can be found here

1. Would the MHRA disagree that a GDC registrant who is engaged in illegal activity may invalidate their indemnity insurance?

MHRA are not responsible for providing advice or guidance surrounding healthcare professionals’ insurance policies. I would recommend that if you have questions or concerns then contact your insurance provider.

Working with other regulators.

1. In Feb 2016 the GDC director of FTP told a registrant “Our internal guidance which is given to caseworkers comprises some 116 pages and is a key document which caseworkers refer to on a regular basis. This document was being reviewed as part of our business as usual activity, and after discussions with the then Head of Casework, the specific sections relating to the MHRA and referrals to the MHRA in light of a breach of the MDD were updated. I have included the relevant extracts from this guidance and would be happy to hear any feedback you may have as to its contents. In addition to this updated guidance, which was circulated to all caseworkers, representatives from the MHRA visited the GDC and provided a training session to our caseworkers on the work of the MHRA, and the regulations surrounding custom made medical devices in particular. The feedback was positive, both from the floor of the meeting where several questions were asked, and from the representatives of the MHRA. Further information relating to the work of the MHRA and custom made medical devices, was circulated to our caseworkers by email after the training. During the course of this project, we also reviewed our processes for recording information relating to a breach of the MHRA regulations, to ensure that our processes were as robust as possible, we implemented a new process for recording incidences of MHRA regulation breaches in our cases system. We are also in contact with the MHRA and are in the process of developing a formal Information Sharing agreement, to ensure that an appropriate level of information is being shared between our two organisations so that in situations where there has been a breach of any relevant legislation, public protection can be guaranteed.   From the caseworker guidance – “71.2 Registration with the MHRA A manufacturer of custom-made devices or their authorised representative must register with the competent authority of the member state in which they have registered the business. Registration will include a description of the devices concerned and the business address. This requirement applies to both general medical devices and active implantable medical devices. Any complaint received about a registrant who is manufacturing medical devices as defined in the Medical Devices Directive 93/42/EC and who is not registered with the MHRA should be referred to assessment and a referral made to the MHRA.”

This information was published in The Dental Technician.

1. Does the MHRA have a ‘formal information sharing agreement’ with the GDC? If yes please can I have the details?
2. If one was not developed, why was the project to remove regulatory gaps unsuccessful?
3. Did the MHRA decline to share data with the GDC?

MHRA work closely with a number of external organisations, including the GDC, on a regular basis to ensure that medical devices within the UK are safe and effective. MHRA will share pertinent information to these external organisations when appropriate under Chapter 4 of the Medicines and Medical Devices Act 2021 to protect patient safety, especially where MHRA have learned of a healthcare professional not performing to standard in the course of an investigation into non-compliant medical devices.

Please note that we are happy to give general advice on the Medical Device Directives and new EU Medical Devices Regulations.  Any views expressed by us on the interpretation of the legislation represent our best judgement at the time based on the information available; they are not intended to be a definitive statement of law, which can only be given by the courts. Accordingly, we would always advise you to seek the views of your own professional advisers.

If you have a query about the information provided, please reply to this email.

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

Please remember to quote the reference number above in any future communications.

If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:

Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

Yours sincerely

MHRA Customer Experience Centre