ISO14155 - Parts 1 & II
This is the international standard for the conduct of clinical studies with medical devices in human subjects. There are plans to produce a unified standard based on both the ISO 14155 and EN540 standards
EN540 (superceded Sept 02)
This is the European Standard for the conduct of clinical studies with medical devices in human subjects to obtain regulatory approval and is referenced in the MDD and AIMD Directives
MDD/AIMDD
The medical device directive and active implantables medical device directive are the European requirements for the approval for sale via the CE mark approval process for medical devices throughout the EU. Annex X of the MDD is related to the conduct of clinical studies
Competent authority
These are the government bodies in Europe which are responsible for the appointment of Notified Bodies and administration of the MDD and AIMDD at national levels. The Medical Device Agency (MDA) is the Competent Authority in the UK - this is now part of the MHRA. The Competent Authority must be approached when planning a clinical study to obtain a CE mark, although the specific requirements vary from country to country.
Notified body
These are the standards organisations (e.g. BSI, TUV) who are responsible for ensuring that a company's procedures are up to the appropriate standard and are involved in the granting process of the CE mark.
FDA
Food & Drug Administration (FDA) in the USA is the regulatory body which controls the licensing and marketing of amongst other things medical devices.
CE mark
This is the mark of approval that allows a product to be placed on the market in Europe.
CE mark study
A clinical study with a product that does not have a CE mark and is therefore designed to obtain regulatory approval.
PMS study
Post Marketing Surveillance Study is a formal study where data is collected to evaluate the wider use of the product after CE marking has been obtained.
Adverse Event
Any undesirable clinical occurrence in a subject whether it is considered to be Device related or not.
Adverse Device Effect
A Device-related Adverse Event.
Note
An Adverse Event or an Adverse Device Effect may be mild, moderate or severe and are usually unexpected. If as a result of an Adverse Event during a Clinical Investigation, a Subject has to be hospitalised or their hospitalisation is unduly prolonged because of a potential disability or danger to life or because an intervention has been necessitated or the event is terminal, the Adverse Event or Adverse Device Effect is regarded as severe
