On 15 May 2024, the Court of Appeal (CoA) handed down a unanimous judgment that a medical device manufacturer could not obtain interim relief to prevent its UK Approved Body (UKAB), BSI, suspending a certificate on grounds of safety and non-conformities before a substantive decision in the manufacturer's judicial review claim. The judgment overturns the first instance decision granting the manufacturer an injunction and mandatory order against BSI.
The CoA judgment emphasises courts' deference to expert regulators, particularly in matters of public health, and that courts are unwilling to restrain a public authority in exercising its powers in good faith, particularly when there is an argument concerning public health. The judgment also reaffirms the principle that the burden is on the manufacturer to demonstrate to the satisfaction of the UKAB the safety and performance of a device. Given this is the first decided case challenging the decision of an Approved Body, there are a number of implications for the UK framework and the relationship with the EU.
Factual background
RRR Manufacturing PTY LTD (RRR) is the legal manufacturer of a small, portable defibrillator (the Device) under the Medical Devices Regulations 2002 (the Regulations). On 24 August 2022, BSI issued a certificate enabling RRR to apply a UKCA mark to the Device to market it in Great Britain. This was on the basis of a limited review of the technical file, as the Device was already certified for use in the EU. That initial certification in the EU was based, at least in part, on the purported demonstration of equivalence with another medical device already on the market.
In 2023, certain stakeholders raised concerns regarding the Device's safe and effective use. This resulted in the Medicines and Healthcare products Regulatory Agency (MHRA) contacting both RRR and BSI regarding potential safety concerns and a lack of clinical evidence to support the safe use of the Device. A "technical surveillance review" by BSI in early 2024 identified that there was neither sufficient clinical evidence to show that the Device was safe and effective nor sufficient justification that it was clinically equivalent to other certified devices. This led BSI to suspend RRR's UKCA certificate in relation to the Device.
First Instance Judgment
In March 2024, RRR applied for judicial review of BSI's decision to suspend the certificate and also applied for interim relief that would in effect require BSI to maintain RRR's certificate in place pending the outcome of the judicial review claim (including after the expiry date on the certificate). In the first instance decision on interim relief, the High Court held that the balance of convenience lay in favour of maintaining the validity of the certificate until the conclusion of the judicial review proceedings.
While the judge took into account the potential public health concerns, she appears to have put significant weight on the fact BSI had not deduced direct evidence that the device was unsafe. The judge also appeared to place significant weight on the potential commercial consequences to RRR as well as that making it unlawful to supply the Device could potentially see the loss of a life-saving innovative product from the market. The judge further noted that the MHRA would still have the power to prevent supply of the product should a sufficient safety concern be identified.
The Appeal
BSI appealed the interim relief decision. On 15 May, the CoA unanimously allowed BSI's appeal giving the following reasoning:
First ground: burden of proof
BSI was concerned about the fact the judge at first instance had essentially reversed the burden of proof under the relevant statutory framework. The CoA confirmed that, when granting interim relief in the context of an application for judicial review, a court does so under the powers in the relevant legislation and case law. The judge must therefore approach the questions through the lens of the applicable regulatory framework. In the current case, that meant assessing whether there was a serious issue to be tried under the regulatory framework for medical devices, and any assessment of the balance of convenience must also be made within that context.
On this basis, the CoA held that the High Court judge incorrectly placed the burden of proof on BSI in expecting it to deduce direct evidence to demonstrate the Device was not safe. Under the medical devices regulatory framework, the burden of proof is on the legal manufacturer of a device to demonstrate the device meets the standards for safety and performance under the Regulations. The manufacturer must do this through the pre-market conformity assessment procedure for the device but must at all times be able to demonstrate the device meets the required standards post-market. BSI did not have the burden of proof to demonstrate that the Device was not safe when, on the basis of a more detailed review of the technical file, BSI had concerns that RRR had not demonstrated the conformity of the Device with the essential requirements in the regulatory framework.
The CoA further held that the first instance judge had been wrong to place decisive weight on the commercial impact the suspension of the certificate would have on RRR, and that the judge should have put little or no weight on the apparent lack of evidence that the Device was dangerous given there was an alternate product on the market that could fulfil the same demands but without the alleged safety concerns. The court further emphasised that an important factor in determining where the balance of convenience lies in public law cases is that the court will not readily restrain public authorities from exercising their power in good faith.
The court summarised the principles that applied to this case as:
- great weight must be given to the protection of public health
- in the context of the medical devices regulatory framework, the manufacturer must satisfy the UKAB that a device is safe and effective
- the court should also give great weight to the assessment of the relevant material by the expert regulator
Applying these, the CoA held that the balance of convenience was in favour of the suspension of the certificate on public health grounds and this was not outweighed by the potential commercial impact to RRR.
Second ground: mandatory order to confirm UKCA mark
A second ground of appeal related to whether the judge was wrong to grant a mandatory order that would force BSI to renew the UKCA certificate when BSI was not satisfied that the Device was safe. The CoA reaffirmed that courts must be reluctant to grant a mandatory order that would compel a public authority to act in a way that it considers to be contrary to the public interest. There were some "obiter" comments from the judges discussing when such an order may be appropriate, but it seems that any such decision would be based on the specific facts and only granted in exceptional cases, if at all.
Impact on the industry
The case is important for both medical device manufacturers and UKABs and clarifies the approach of the courts to reviewing a decision of a UKAB. This is the first case against a UKAB and leads to some important additional points:
- Manufacturers: the case highlights the challenges in preventing a UKAB from suspending a certificate through interim relief before a court has made a determination on the lawfulness of that decision to suspend. This is the case even where there is little or no evidence of harm.
- UKABs: The case will provide some comfort to UKABs that they will not necessarily be forced to maintain a certificate for a device during ongoing judicial review proceedings where there are doubts as to its safety, nor that they will be compelled to "extend" a certificate beyond an existing expiry date during any such proceedings.
- Public health: The case confirms that such decisions must be made on public health grounds. Suspension decisions can be made on public health grounds taking into account the standards for safety and performance set out in the regulatory framework, rather than taking into account the commercial impact on the relevant manufacturer. However, while it is concerning that such decisions can be taken in the face of little or no evidence of harm, the CoA did indicate that the balance of convenience could be different where patients did not have access to an alternative device. For RRR, that the conformity assessment procedure had relied on equivalence with an existing competitor device meant it was straightforward to identify an alternative. Manufacturers may have more success in arguing the balance of convenience lies in maintaining the certificate where they have not relied on equivalence – this will likely be the case less and less often given the EU medical devices regulatory framework has moved away from equivalence and places greater focus on clinical evidence for new devices (and the new Great Britain regime is expected to take a similar approach once finalised).
- International recognition: The case also has implications for the international recognition of medical devices. As set out in our previous blog, the MHRA recently announced its proposals for wider recognition of international recognition of "approvals" for devices, and it is expected that UKABs will carry out the limited reviews under this process. The judgment implies that UKABs will have significant discretion to take action in respect of devices for which they have only conducted a limited review, but later have reasons to doubt the safety or conformity of the device. Within the EU, different notified bodies are unlikely to review the same device, but the additional review in the UK post-Brexit may provide a second layer of security for devices. In this case, the Device is CE marked in the EU and this CE mark remains, as far as we are aware, valid.
- Ability to challenge UKABs: The judgment does not decide on whether UKABs are amenable to judicial review – BSI reserved its position and the judges did not hear arguments on this matter. UKABs (and the predecessor Notified Bodies) have long argued that they are not amenable to judicial review under English administrative law. However, many argue that in matters such as those at issue in this case, UKABs are exercising public law functions and therefore their decisions should be able to be challenged in the courts. The decision in the substantive proceedings in this case should provide clarity on this point.
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