RRR Manufacturing Pty Ltd (RRR, the respondent) is the legal manufacturer of a small, portable defibrillator (Cell AED®, a Class II medical device) under the Medical Devices Regulations 2002.
On 24 August 2022, British Standards Institution (BSI, the appellant) 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.1
As stated in the appeal court judgement, the device had a valid CE certificate from an EU body (DQS) based on RRR’s assertion that the device was equivalent to the Philips HeartStart HS1.
Below is an attempt to provide the circumstances leading to the appeal from BSI and the subsequent judgment from the appeal court.
Taking the time to read the judgement, the references provided below as well as viewing Parts 1 and 2 of the appeal from BSI (links provided below) could facilitate a much better and deeper understanding of the facts and nuances concerning this case.
Background to the appeal from BSI
- In 2023, certain stakeholders raised concerns regarding the Device’s safe and effective use.1
- This resulted in the UK MHRA contacting both RRR and BSI regarding potential safety concerns and a lack of clinical evidence to support the safe use of the Device.1
- 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.1
- Following the review and several other steps including asking RRR for Corrective Action Plans, BSI then decided to suspend the certificate of the Device in question.
- In March 2024, RRR applied for judicial review of BSI’s decision to suspend the certificate and also applied for interim relief (via an injunction) 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).1
- 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.1
- 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.1
- 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.1
- 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 High Court Court Judge made an order:
- (1) restraining BSI from withdrawing or suspending the certificate,
- (2) requiring BSI, when the certificate expires on 26 May 2024, to extend or to renew the certificate until the determination of the application for judicial review (or further order) and
- (3) requiring BSI to pay RRR’s costs of the application for interim relief (‘the order’).
- BSI applied for permission to appeal from the order.
- BSI appealed the interim relief decision on three grounds:2
- Ground 1 was that the Judge misunderstood both the burden of proof under the relevant statutory framework, and what it was that had to be proved2
- Ground 2 was that the Judge had been wrong to issue a mandatory order forcing BSI to renew the UKCA certificate at a future date in circumstances where BSI was not satisfied that the device was safe;2
- Ground 3 was that costs should have been reserved until the outcome of the application was known, as the costs order against the BSI pre-empted the outcome of the JR proceedings.2
The appeal hearing and judgement
- The Court of Appeal conducted an expedited rolled up hearing. Here, you can view Part 1 and Part 2 of the appeal hearing.
- All three judges handed down judgments and were unanimous that all three grounds of appeal should be allowed. They set aside the prohibitory order (restraining suspension), the mandatory order (requiring the BSI to renew the certificate) and the costs order.3
Here, you can view the judgement (delivered on 15 May 2024) from the appeal.
References
1. Court of Appeal rules on suspension of UKCA certificates – Jackie Mulryne et al, 13 June 2024 Bioslice blog
2. Public law update: RRR Manufacturing Pty Ltd v British Standards Institution and MHRA [2024] EWCA Civ 530 -Darryn Hale et al, DAC Beachcroft, 17 May 2024.
3. Court of Appeal overturns grant of interim relief in judicial review – Tim Johnston, Brick Court Chambers, 15 May 2024.