Schedules Schedule 3: Offences of breaching provisions in the Medical Devices Regulations 2002 Part 1: Offence 60A Offence of breaching certain provisions
This inserted regulation outlines the definition of an offence under certain circumstances. The circumstances are defined as where a person fails to comply with a requirement or breaches a prohibition contained in a provision listed in the Schedule to the MDR inserted by Schedule 3.
	Paragraph 2 sets the maximum penalties a person may be subject to if guilty of an offence. These are:
As a result of a summary conviction in England and Wales, which is an offence that is only triable in a magistrates court, and is often summarised without the need for trial, a person can be imprisoned for up to 51 weeks, receive a fine, or both.
As a result of a summary conviction in Scotland or Northern Ireland, a person can be imprisoned for up to 6 months, or receive a fine not exceeding £5,000, or both. A level 5 on the standard scale references the scale of fines for summary offences as outlined in the Criminal Justice Act 1982.
	Paragraph 3 sets out the limitation period that applies in relation to the offence, which is the earlier of:
the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor; and
the end of the period of three years beginning with the day on which the offence was committed.
	Paragraph 4 outlines that a certificate outlining the date on which the evidence came to the prosecutor’s knowledge and that is signed by the prosecutor is to be considered conclusive evidence that the evidence referred to above has come to the prosecutor’s knowledge.
	Paragraph 5 outlines that the maximum 51 weeks imprisoned outlined in paragraph (2)(a) should be 6 months if the offence is committed before section 281(5) of the Criminal Justice Act 2003 is commenced.