Key Facts
- •RRR Manufacturing Pty Limited (RRR), an Australian company, manufactures CellAED, a handheld smart personal defibrillator.
- •CellAED received CE certification in the EU (May 2021) and UK market certification from BSI (August 2022).
- •BSI, at the MHRA's request (following concerns raised by a competitor), initiated a review of CellAED's certification, leading to a report identifying non-conformities and requests for corrective action plans (CAPs).
- •RRR appealed BSI's decision, which was refused. BSI then indicated its intention to suspend RRR's certificate.
- •RRR sought judicial review, claiming BSI's actions were unlawful (illegality, procedural unfairness, irrationality, fettering of discretion).
- •RRR requested a stay of proceedings and arbitration, but BSI declined.
- •RRR applied for interim relief to prevent suspension of its certificate pending the judicial review.
Legal Principles
Principles governing the grant of interim relief in judicial review proceedings (American Cyanamid principles, modified for public law cases).
American Cyanamid Co v Ethicon Limited [1975] AC 396; R (Medical Justice) v Secretary of State for the Home Department [2010] EWHC 1425 (Admin)
A serious question to be tried requires a real prospect of the claim succeeding at the substantive hearing.
R (Medical Justice) v Secretary of State for the Home Department [2010] EWHC 1425 (Admin)
Damages are rarely an adequate remedy in judicial review claims.
The balance of convenience considers harm to the claimant and public interest if relief is not granted vs. harm to the defendant and public interest if relief is granted.
Public interest favors respecting a public body's decision unless set aside; the strength of the claim is significant in assessing the balance of convenience.
Outcomes
Interim relief granted: BSI restrained from suspending or withdrawing RRR's certificate until the claim is determined.
RRR demonstrated a serious question to be tried; damages are inadequate; the balance of convenience favors maintaining the status quo, considering potential harm to RRR and the public interest in maintaining access to potentially life-saving medical devices; MHRA has other powers to address safety concerns if necessary.
Injunction extended to require BSI to maintain certification until the claim's determination, potentially through extension or time-limited renewal of the existing certificate.
To avoid defeating the court order and ensure the issue of certification is not used against RRR while the court considers the underlying legality of BSI's actions.
Permission hearing postponed to a 'rolled-up' hearing with the substantive hearing.
To save time and resources.