Regulatory Framework Flashcards
What is the definition of regulation?
a rule prescribed for controlling matter or conduct
What is the difference between the UK and Great Britain ?
UK - England Wales Scotland and NI
GB - England Wales Scotland
What is the difference between Europe and the EU?
Europe - geographical continent
EU - group of European countries with aligned regulations.
What are the types of rules in the EU ?
A regulation is binding to all members of the EU and is directly applicable.
A directive is binding to all members as result but there is leeway on how this is achieved.
A decision is only binding to the members which are directly addressed.
What are the types of legislation available by the government ?
Acts – > primary legislation (ascent given by the monarch )
statutory instruments –> secondary legislation (ascent given by the parliament )
Name some relevant primary and secondary legislation to the field of biomedical engineering
Consumer rights act of 2015 –> used by MHRA to inspect and investigate.
Customer protection act of 1987 –> introduced secondary medical device and general product regulations .
Medical devices Act 2021
What is lex specialis ?
specific laws for an industry
What is the MHRA ?
medicines and healthcare regulations agency which regulates medicines, medical devices and blood components in transfusions.
Sponsored by department of health and enforces and regulates the UK MDR.
What are the MDR and the IVDR ?
Medical device regulations and in vitro diagnostic regulations bought in the EU in 2017 to combine the MDD, IVDD and the AIMDD.
What were the planned EU exit dates for GB and what are they post covid ?
Planned exit on 31st Jan 2020 with IP completion in 31st December 2020.
Would have meant IVDR would never have been applied to UK and MDR would only have been applied for a few months.
Covid meant MDR and IVDR were pushed back by a year so were never applied to UK.
What are the differences between UK MDR and MDR ?
UK MDR is a designated standard where the MDR is a harmonised standard.
UK MDR requires devices to have either a UK CA or a CE mark whereas MDR requires a CE mark.
UK MDR applies to devices under MDR and IVDR.
What are the differences between MDR + IVDR vs UKMDR for device classification ?
MDR contains a class Ir ( re-usable) whereas UK MDR doesn’t.
There are more class of in vitro devices in IVDR (class A to D ) vs UK MDR (list A equivalent to class C and list B equivalent to class D)
What is the difference between a notified body and an approved body ?
notified body –> organisation designated by an EU country to assess conformity before products are placed on market (3RD PARTY)
Approved body –> organisation designated by MHRA to assess conformity with the UKMDR regulations
Conforming devices contain a 3 digit number next to their respective marks.
What are class I and class II devices ?
class I protective earthing
class II double insulation
What do manufacturers have the legal obligation to report and what are the 3 types ?
Must report incidents.
Incident –> least serious
serious incident –> directly or indirectly led to death, temporary health deterioration or serious public health threat.
serious public health threat –> could cause imminent risk of death or serious illness that may need remedial action (change to ensure conformity )
