**You are allowed to modify equipment without invalidating its CE mark)......
True.... but only with the written approval of the design authority in this case G.E!
And only then with such approved details of any modifications filed in the device safety master file having had audit for UL and CE implications.
http://www.mhra.gov.uk/Howweregulate/Dev...ights/index.htmMHRA Enforcement Responsibilities
1. The Secretary of State for health is responsible for administering legislation relating to medical devices and for ensuring the safety and quality of devices. The relevant legislation is the Medical Devices Regulations 2002 (SI 2002 No 618) and Medical Devices (Amendment) Regulations 2003 (SI 2003 No 1697) and General Product Safety Regulations 2005 (SI 2005 No 1803).
2. In respect of both the Medical Devices Regulations 2002 (SI 2002 No 618) and Medical Devices (Amendment) Regulations 2003 (SI 2003 No 1697) for the purposes of enforcement, these regulations are safety regulations under the Consumer Protection Act 1987.
3. The General Product Safety Regulations 2005 (SI 2005 No 1803) enforcement will be under the Regulations themselves with respect to distributors/suppliers who make available to the public, medical devices which are consumer products, as defined by the Regulations.
4. MHRA has a duty to enforce this legislation on behalf of the Secretary of State and has delegated responsibility for England, Wales, Scotland and Northern Ireland. This involves establishing that the Medical Devices Regulations and General Product Safety Regulations have been complied with, and ensuring that the appropriate action is taken wherever necessary to prohibit or restrict unsafe products being placed on the market.
5. The above obligation is met by MHRA in 5 basic ways:
a. Any complaints about CE marked products or products which are not CE marked that are drawn to our attention, will be investigated.
b. Selection for inspection of a sample of manufacturers who place their products on the UK market. Inclusion in this proactive exercise does not mean that there has been a breach of the Regulations.
c. Regular monitoring of the activity of Notified Bodies designated by MHRA to assess the compliance of manufacturers of, in the main, higher risk devices.
d. Investigations undertaken as a result of vigilance reports.
e. Investigations as to complaints concerning unsafe products supplied/distributed to consumers under the General Product Safety Regulations 2005.
I personally would be quite worried to think that ebme departments were making changes to original equipmend designs and fitting sub standard or non approved parts as they saw fit!
regards
broadbean
