Medical device manufacturers and your Approved Body

What to do in the light of new case law if you consider your notified body has made a wrong decision

How to work with your approved body

Medical device manufacturers often have difficult relationships with their approved bodies ('notified bodies' in the EU). The stakes are high: without the certificate of conformity, the manufacturer cannot start to place their medical device on the market. All their economic eggs are in one basket. We are often asked to intervene when manufacturers reach a brick wall: sometimes simply "the computer says no", sometimes there are very long timelines to getting anything done and sometimes we see variations on those themes.

The first step should always be to talk to your approved body, escalating up the management chain. If this fails, manufacturers should look to their contract for the appeals procedures. These should be followed, if necessary, with the help of a lawyer to shape any legal or regulatory arguments. If these yield no satisfactory outcome, it is possible to ask for the MHRA to intervene. In the past the MHRA would do so in the face of manifest error, not to change the decision, but firmly to request a rethink by the approved body. Unfortunately, with the MHRA under-resourced at present, any, and certainly a timely, intervention on their part is less likely.

If the manufacturer has exhausted the discussion with your approved body, then legal action might be the next step. We recommend considering options carefully with your legal advisers. The contract between the applicant and the approved body may of course make specific provision as to how legal claims should be conducted, but in our view the contract is unlikely to represent the limit of the manufacturer's legal options, even if the contract provides for arbitration as the final means for deciding on disputes. Judicial review of the correctness of the decision of the approved body remains an option for manufacturers and the process will conclude much more quickly than an action for damages. This article discusses a recent case on the topic which illustrates the scope and limitations of this process.

New case law on judicial review of an approved body decision

Over the last few weeks, a case (RRR Manufacturing v BSI) has played out in the High Court along conventional lines. In that case the manufacturer had its right to participate in the market withdrawn by an approved body and challenged that decision. The courts backed the approved body. The dispute does however raise an important question as to the applicability of judicial review to the decisions of approved bodies.

Facts of the case

RRR Manufacturing is an Australian company which developed a handheld defibrillator. This gained a CE certificate indicating that it conformed with European Union standards in 2021. In 2022 BSI issued an equivalent certificate which enabled RRR to market the product in the UK. 

In September 2023 BSI had second thoughts and commenced a review of the certificate. This apparently reflected concerns first raised by third parties (who may have been commercial rivals) with the MHRA. It was asserted that there was insufficient clinical data to confirm safe and effective use and a "lack of peer-reviewed clinical evidence". 

In January 2024, BSI issued a report setting out various non-conformities. RRR appealed within BSI on the basis that the BSI did not follow proper process. That appeal was dismissed, and BSI confirmed its decision to suspend the certificate. 

RRR considered it had exhausted all available appeals and so applied to the High Court for urgent relief (an injunction), to prevent BSI suspending the certificate as well as judicial review of the lawfulness of the BSI's decision.

The judge granted the relief sought, being: 

• an order restraining BSI from suspending the certificate 
• an order that the certificate (which was due shortly to expire) should continue in operation until the lawfulness of BSI's actions had been determined 
• an order that any application for permission to seek judicial review and the substantive hearing should be 'rolled up' into one hearing to save time.

BSI appealed this decision and in due course the Court of Appeal struck down the judge's order on the basis she had erred in law.

The Court of Appeal was reluctant to interfere with the exercise of the discretion of a public authority, citing the "obvious proposition" that the High Court "will not readily restrain a public authority in the exercise of its functions". In addition of course "great weight must be given to the protection of public health and ..in this regulatory framework ..the manufacturer must satisfy the approved body that a device is safe and effective". The judge had erred in giving "decisive weight...to the commercial damage which the suspension of certificate would inflict on RRR".

The judge had relied on a lack of evidence before her that the device was unsafe, when in fact the burden of proof should be the other way around.
The Court of Appeal took a conventional public policy approach that the courts cannot allow devices on to the market which the regulator considers dangerous just because the regulator may have failed to follow the right procedure. The urgency of this application meant that the court was required to decide whether a product should be on the market. Placed in that situation it was always bound to take the most cautious line from a public health perspective. That does not mean that the regulator is immune from applications that it acted unlawfully, just that urgent injunctive remedies requiring the court to decide what products are on the market may be hard to obtain. A regulator in the position of BSI could still be ordered upon judicial review to re-visit a faulty decision in the right circumstances.

A more novel point was whether BSI is a regulator discharging a public law function whose decisions might therefore be challenged through judicial review. This was not taken as a given. At the first hearing RRR suggested that the action be stayed, and the dispute taken to arbitration (an offer the BSI refused). Before the Court of Appeal, BSI reserved its position as to "whether it is amenable to judicial review at all, on the basis that its relationship with RRR is purely contractual".

Contractual claims against approved bodies 

Approved body standard terms provide for rights of appeal within the body but very limited remedies beyond that. Any claim for loss of profit will generally be barred. Any damages claim for breach of contract will usually be limited to the return of the fees charged by or paid to the approved body. This does not provide much leverage for an aggrieved manufacturer. 

The fact that there is such a contract between the manufacturer and the approved body, and thus that the manufacturer has (limited) remedies in contract does nothing, to change the public law nature of the approved body's role. Judicial review is always a last resort only to be sought when the applicant for judicial review has exhausted all available remedies but a very limited claim for damages which might take many months to reach the courts is not a relevant remedy to an applicant seeking access to a market now. 

Option for a judicial review of an approved body decision

Approved bodies for medical devices are appointed by the MHRA and exercise their powers under the Medical Devices Regulations 2002 for medical devices in Great Britain: UK approved bodies for medical devices. Approved bodies are therefore discharging a public law function and ought always to be subject to public law remedies.

If an approved body determines that a medical device is not compliant, it cannot be marketed in Great Britain. It is difficult to think of a clearer example of a body discharging a public law function. The Court of Appeal did not reach a formal decision on this point, but it did address the suggestion that BSI reserved its position as to whether it "is amenable to judicial review at all, on the basis that its relationship with RRR is purely contractual, and therefore only governed by private law. We have not heard argument on this point. I would only observe that if BSI was exercising public powers (which is the premise of the application for judicial review, and of the appeal) it would not be lawful for it to abdicate those functions to an arbitrator."

Manufacturers who feel they have been unjustly denied access to a market by an approved body may apply to the Administrative Court for relief if they can show that that decision was unreasonable or not reached by following a proper process, provided they have first exhausted their rights to challenge the decision. These appeal procedures will be set out in the contract and should be followed first, but the fact that the relationship is governed in a contract (and that contract says all claims should be referred to arbitration) does not mean that the applicant loses its (separate, non-contractual) right to seek judicial review.

Conclusion on judicial review

Judicial review applications are of course difficult, as this case illustrates. They should only be launched after careful thought and it is vital that early legal advice be obtained, not least because an application for judicial review must be brought within very strict time limits. They do nevertheless offer a viable means for obtaining redress in the event a medical device manufacturer faces an approved body's manifestly incorrect decision on certification.