Schedules Schedule 3: Offences of breaching provisions in the Medical Devices Regulations 2002 Part 1: Offence 60B Defence of due diligence
This insertion sets out the defences available.
	Paragraph (1) provides that a person being prosecuted for an offence under Regulation 60A can use the defence of due diligence if they can prove they took all reasonable steps to avoid committing the offence.
	Paragraphs (2) and (3) provide that a person cannot, as part of their defence, claim that the offence was due to either another person’s action/default or to reliance on information provided by another person, unless they have first notified the prosecutor. That notification must include any information the defendant has that may assist in identifying the other person. The notification must be served at least 7 days before the hearing.
	Paragraph (4) states that a person cannot rely on the defence of due diligence if they are relying on information provided by another person (as set out in paragraph 2(b)), unless the defendant can prove it was reasonable to rely on this information. This has to have regard to whether the defendant has reason to disbelieve the information, and steps taken to verify the information.
	Paragraph (5) provides that in the application of regulation 60B to Scotland, references to the defendant are to be read as references to the accused and references to "the hearing of the proceedings" are to be read as "the trial diet".