I have found two different interpretations of the phrase “legal entity”
which has implications in the application of the IVD Directive to work done
by an NHS lab for another Trust, including GP Direct access work from
PCT's.
The Department of Health appears to regard the NHS as part of the legal
entity called “The Crown” (ref 1). The MHRA, an Executive Agency of the
Dept. of Health, regards Health Institutions as legal entities (ref 2). To
my simple mind the only way of reconciling these two definitions is by
treating the NHS as a single Health Institution.
The alternative is that the NHS is not part of “The Crown”. Some of us will
remember the public sector (including hospitals) losing “Crown Immunity”
for Health and Safety issues which to my mind implies that at that time at
least the NHS was indeed part of the Crown.
Does anybody have access to a good lawyer?
Dennis Wright
Ref 1 Service Level Agreements
27. There must be two parties to form a contract. One application of this
rule is that,
because public sector organisations are often officially part of the single
legal entity called
the "Crown", they cannot form "contracts" with each other. Agreements
between public
sector organisations are usually called Service Level Agreements, to
distinguish them from
legally enforceable documents. However, whatever these documents are
called, they cannot
be enforced in a court of law because the Crown cannot sue itself.
(http://www.dh.gov.uk/assetRoot/04/07/06/12/04070612.pdf )
Ref 2 Scenario 3: Health Institution A manufactures and uses an IVD to test
patient samples provided by another legal entity.
In this case the device is not being used "within" the same health
institution because it is being used for the provision of services to a
third party (ie the testing of third party samples). Our view is therefore
that the IVDD and Regulations apply and Health Institution A will need to
comply with the relevant requirements. This remains our view regardless of
whether or not it is providing this testing service as part of a commercial
transaction.
(
http://devices.mhra.gov.uk/mda/mdawebsitev2.nsf/webvwKeyTopics/DC3A7FD0D7337
51680256D56004F7C67?OPEN )
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