“(i) Is there a serious issued to be tried? (ii) If so, would damages be an adequate remedy for the claimant(s) if the suspension were lifted and they succeeded at trial; is it just in all the circumstances that the claimant(s) should be confined to a remedy in damages? (iii) If not, would damages be an adequate remedy for the defendant if the suspension remained in place and it succeeded at trial? (iv) Where there is doubt as to the adequacy of damages for either of the parties, which course of action is likely to carry the least risk of injustice if it transpires that it was wrong; that is, where does he balance of convenience lie?”
“… the next question is to ask how long a period the suspension might be and to what extent it should be in force. You cannot assess the later Cyanamid questions without this essential background. ….”
“19. I do not consider, on an application to lift the suspension in a typical procurement case, that this is an appropriate matter for the court to investigate. Such cases are a long way from a straightforward claim for an interlocutory injunction, where a particularly good point on a substantive dispute (an admission, say, or an unequivocal contractual term in one side’s favour) might well be of assistance to the court’s consideration of the application overall. It is not appropriate to have a mini-trial in a complex procurement dispute like this. Where, as here, it is accepted that there is a serious case to be tried, then (save in exceptional circumstances) both sides should resist any further temptation to argue about the merits. … 21. … Accordingly, save in the exceptional circumstances where one party has some kind of simple “knock-out” point, I do not consider it appropriate as a matter of principle for the court to conduct a mini-trial or to endeavour to reach any conclusions as to the strength or weakness of one or both sides’ cases.”
“The software Emolife, the BECS module of the product GPIMed4.Blood, is certified as class IIB medical device in accordance with the Regulation MDR 745/2017.”
“in vitro diagnostic medical device” means a medical device which— (a) is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination; and (b) is intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information— (i) concerning a physiological or pathological state, (ii) concerning a congenital abnormality, (iii) to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or (iv) to monitor therapeutic measures, and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.” (i) concerning a physiological or pathological state, (ii) concerning a congenital abnormality, (iii) to determine the safety and compatibility of donations, including blood and tissue donations, with potential recipients, or (iv) to monitor therapeutic measures, and includes a specimen receptacle but not a product for general laboratory use, unless that product, in view of its characteristics, is specifically intended by its manufacturer to be used for in vitro diagnostic examination.”
““accessory” means an article intended specifically by its manufacturer to be used together with an in vitro diagnostic medical device to enable that device to be used in accordance with its intended purpose, which is not – (a) itself an in vitro diagnostic medical device; (b) an invasive sampling medical device; or (c) a medical device which is directly applied to the human body for the purpose of obtaining a specimen.” (a) itself an in vitro diagnostic medical device; (b) an invasive sampling medical device; or (c) a medical device which is directly applied to the human body for the purpose of obtaining a specimen.”
“7.1 Our client considers that it is clear that any solution that meets all of the requirements set out in the Specification at Appendix A of the ITT will be a “medical device” as defined in theMedical Devices Regulations 2002 …. Accordingly a bidder may only lawfully propose, and the Authority may only lawfully accept, a tender to provide a solution that is fully compliant with the MDR and MHRA’s requirements for a medical device. … 7.5 … Based on our client’s market knowledge of GPI’s products and the limited feedback available, our client anticipates that GPI may have bid on the basis of its eDelphyn product. 7.6 If that is correct, our client is very concerned to note that, at the time of writing, our client understands that eDelphyn is not in compliance with the requirements to be met prior to placing a medical device on the market, as set out in the MDR. In particular, our client understands that eDelphyn does not have a CE-IVDR, CE-MDR or UKCA certification and is not registered with the MHRA. … 7.8 … This is despite the fact that GPI holds relevant CE-MDR/CE-IVDR certifications for other products in its range (Emonet and Emolife) that offer similar functionality to eDelphyn in the EU, notably in the Italian market.”
“It is further averred that those aspects of the Gpi4Med.BloodEmolife suite (the product) offered by the successful tenderer) which so interact with third party IVDR instruments, namely the WEBLAB module, are in any event covered by an appropriate CE-IVDR held by that tenderer. This is in addition to the CE-MDR held by the tenderer that covers Emolife which is the BECS module within the GPi4Med.BloodEmolife suite.”
“Founded in 1984, the MAK-SYSTEM brand has established a dominant position in the vein-to-vein blood management market, with more than 100 customers across 35 countries, including national blood services, major hospital networks and global pharma companies … ePROGESA – the original blood collection management platform and largest product by revenue,. This product is the industry gold-standard for managing the blood collection, analysis and storage process, and is used by more than 20 national services globally.”
“The evidence before the court does not indicate that this procurement is unique or high value. However, it is being closely watched by a number of other fire and rescue services and is likely to be perceived as setting the standard for improved protective equipment in this sector. On that basis, it is arguable that, if the automatic suspension is lifted and Draeger is ousted from its position as the incumbent provider of breathing apparatus for LFB, it will suffer a loss for which damages are not an adequate remedy.”
“It is a requirement that Bidder’s (sic) must be able to deliver all three options detailed in paragraph 6.8 as part of their offering during the life of the Contract, however, option 1 as a minimum must be available from the Services Commencement Date ie1st December 2027 . During the contract Implementation Period the Commissioner and Provider will agree the timescales for scheduling and implementing the additional module options and system functionality.”
“The lack of a fully compliant BECS risks incorrect donor eligibility decisions, release of components without complete testing, mislabelling or data integrity errors, inability to rapidly trace, quarantine and recall affected units, and delayed or incomplete reporting.”
“…. it will not normally be an answer to this point for a claimant to contend that the changes are not in fact material or that they do not amount to an improvement. The effect of the continuation of the suspension in circumstances such as those here is that the public body in question is being prevented for (sic) arranging for services to be provided in the form and on the terms which it wishes and which it regards as beneficial. That is a loss which cannot be compensated in damages. The point is reinforced by the fact that consideration of the balance of convenience is required unless the court is satisfied that damages will be an adequate remedy ….”
“When determining where the balance of convenience lies: (i) the court should consider how long the suspension might have to be kept in force if an expedited trial could be ordered ….; (ii) the court may have regard to the public interest: Alstom Transport v Eurostar … at [80]; (iii) the court should consider the interests of the successful bidder, alongside the interests of the other parties: Openview …: (iv) if the factors relevant to the balance of convenience do not point in favour of one side or the other, the prudent course will usually be to preserve the status quo (or, perhaps, more accurately, the status quo ante), that is to say to lift the suspension and allow the contract to be entered into: Circle Nottingham Ltd. v NHS Rushcliffe Clinical Commissioning Group[2019] EWHC 1315 (TCC) at [16].” (i) the court should consider how long the suspension might have to be kept in force if an expedited trial could be ordered ….; (ii) the court may have regard to the public interest: Alstom Transport v Eurostar … at [80]; (iii) the court should consider the interests of the successful bidder, alongside the interests of the other parties: Openview …: (iv) if the factors relevant to the balance of convenience do not point in favour of one side or the other, the prudent course will usually be to preserve the status quo (or, perhaps, more accurately, the status quo ante), that is to say to lift the suspension and allow the contract to be entered into: Circle Nottingham Ltd. v NHS Rushcliffe Clinical Commissioning Group[2019] EWHC 1315 (TCC) at [16].”