Alex
The Medical Device Directive is enacted into UK Law as the Medical Devices Regulation under a Statutory Instrument which means any breaches can be prosecuted. Failing to maintain in accordance with the MDD is a breach and therefore a breach of the MDR. The worst case scenario is that whoever is responsible for the breach whether it is the Trust or an individual CAN be prosecuted. Breaches may not be criminal but they are against UK law and therefore punishable by the courts. The MHRA assume the responsibility of the police for the MDR as the UK Competent Authority (trying not to laugh as I type)
As you say the legal field is complicated which is why the MHRA won't make definative statements and point us in the direction of the courts and our own lawyers. Look at the French who have raised prosecutions against manufacturers and the healthcare profession for breaches of the MDD.
We cannot get complacent and assume that we will not face legal consequences, the fact of the matter is we just don't know what the punishments are if an incident occured and we did not follow the manufacturers recommendation even though it is obviously to us that it was not the cause of the incident.
Unfortunately we are working in a field where we must cover our backs, this is the consequence of the public taking more readily to legal action.
Also I raised the issue of varying maintenace schedules with the MHRA in the past. Basically they said if we get written confirmation from the manufacturer accepting our revised procedures then we would not fall foul of the MDR. We approached a few pump manufacturers in the past and were informed that they have passed it on to there regulatory affairs and legal team, 2 years on we are still waiting for a response.
