Consultation outcome

Chapter 2 - Classification

Updated 26 June 2022

Since the classification rules were established for medical devices, there has been significant technological progress. The existing classification rules are, in some respects, out of step with best international practice, particularly for implantable medical devices such as surgical mesh and software as a medical device.

The changes we intend to introduce take advantage of the significant opportunity we have to amend the classification rules for general medical devices. They will help ensure medical device classification better reflects changes in technology and better accounts for how medical devices are used in a modern world, including the level of invasiveness and potential toxicity of certain devices. The changes will update the classification rules within the UK medical devices regulations to better align with best international practice and ensure that the scrutiny a medical device receives is commensurate with the level of risk that the device presents.

Section 5 - Classification of general medical devices

5.1 Possible changes

The consultation invited views and comments on possible changes to classification rules for general medical devices in the UK medical devices regulations, with examples provided in the consultation text.

The abridged consultation in Chapter 17 also invited views on possible changes to classification rules for general medical devices in the UK medical devices regulations, with examples.

5.2 Feedback

Overall, a large proportion of those commenting on this section of the consultation were in favour of the possible classification changes outlined in the consultation. Of the 470 responses in this section:

• 70% were in favour of amending the classification rules for general medical devices in the UK regulations in any or all of the ways set out in the consultation
• 13% were not supportive
• 17% did not know or had no opinion

A small number commented on which of the proposed amendments they were in favour of. Overall, 126 respondents commented in favour of all proposed changes. Many highlighted the importance of alignment with EU Medical Devices Regulation (2017/745) (EU MDR). A small number expressed support for particular changes, including those concerning re-classification of:

• active implantable devices and accessories
• in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
• surgical mesh
• joint replacements
• spinal implants
• nanomaterials
• changes impacting devices inserted into the mucous membrane
• delivering a drug by inhalation
• applied to the skin or a body orifice
• involving closed loop systems/automatic defibrillators

A small number expressed concerns about specific changes among those set out in the consultation, including:

• the regulatory burden and costs that changes to classification of active implantable devices and their accessories would bring
• some respondents noted that the proposed changes would render all types of device involved in IVF/ART procedures Class III medical devices, thereby increasing costs and reducing access to those procedures
• some respondents considered that making surgical mesh Class III may be disproportionate

When asked to outline any other amendments which should be made to the classification rules, the following themes were raised:

• a small number felt that there should be a classification rule explicitly on dermal fillers - however, no clear rationale was expressed for changing how dermal fillers in scope of classification rules are currently classified
• a number of respondents commented on the need for clear guidance to help manufacturers determine the correct classification, and some commented that the classification of borderline devices should be met with more flexibility

The abridged consultation (Chapter 17) invited views from respondents on whether the classification rules for general medical devices and in vitro diagnostic medical devices (IVDs) should be amended as outlined in the consultation text. Of the 59 responses received:

• 85% were in favour of amending the classification rules as outlined in the consultation text
• 8% were not in favour of these amendments
• 7% did not know or had no opinion

When respondents were asked in Chapter 17 to provide their reasoning for their answer to the previous question or any general comments on the classification of medical devices (including ideas for other ways classification may need to change), 23 responses were received, and the following themes were raised:

• UK regulations should be aligned with the EU
• device classification should be risk based

5.3 The government response

Having considered the views of respondents, and including the concerns outlined above, the government remains in favour of progressing all classification changes set out in the consultation, subject to the following:

• the amendments it is considering around the classification of IVF/ART related devices would apply specifically to substance-based devices used in vitro in direct contact with human embryos before implantation or administration into the body, and not to every tool used in IVF/ART. We consider that up-classification is warranted for these limited devices involved in IVF/ART to ensure that the classification risk is commensurate with the risk that such a device presents, but not for all devices involved in these procedures, the majority of which are classified appropriately by existing classification rules, and
• the amendment to the classification of medical devices incorporating nanomaterials (being classified between Class IIa – III depending on potential internal exposure levels) should apply not only to those incorporating nanomaterials, but also to those generating nanomaterials.

We acknowledge concerns raised by respondents about up-classifying surgical mesh but consider that this change is warranted to ensure the classification of these products is commensurate with the risk they present and to better protect patient safety. The government also acknowledges interest in clear guidance around classification rules and any changes to these - and will ensure that suitable guidance on classification rule changes is made available.

The government remains of the view that these changes will enable classification to be more commensurate with the risk of a medical device, ultimately helping to support the safety of medical devices, while supporting global harmonisation regarding how medical devices are classified. For the government’s position on the classification of IVDs and of software as a medical device, see Chapters 9 and 10 respectively.