It is important to note that CE marking does NOT endorse any product as meeting standards. CE marking is only awarded to companies that meet the manufacturing requirements and standards that allow them to sell and market within Europe, it does not mean that the products meet any specification standards.
This depends on the risk classification of the device as far as I'm aware - otherwise we'd be in a situation where every device, irrespective of potential risk it may present to patients, by virtue of how it is connected, physical effects it has on the patient, etc, would be CE marked and in use - simply based on the manufacturer's quality system meeting the required standards.
As far as I'm aware the
notified body number, in conjunction with a valid certificate of conformance, gives an indication that a device, presenting a particular, potential, risk to patients meets the applicable BS/EN standards (this depends on the particular MDD annexes that apply, based upon the risk classification of the device; thus risk establishes the approach taken towards certification and whether manufacturing standards necessarily apply, I think).
The applicable manufacturing and quality system standards should be indicated on the certificate provided by BSI if they type tested the device. The question is which Standard does the flowmeter fail to meet - MDD annexes will indicate some "standard" that needs to be applied and the CE mark indicates conformity in the European market under MDD - that's the whole point of it I think.
