Medical device directive

Question 1

What is the MMD?

Answer 1

Medical Device Directive

EU legal frame work to harmonise laws related to medical devices within the EU

For a manufacturer to place a medical device on the market they must comply with the medical device directive

Products must also be CE marked before being placed on the market

Question 2

What is classes as a medical device?

Answer 2

any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended (intended purpose) by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, treatment or alleviation of disease, (Not a drug)

Question 3

What are the 3 classes of medical devices?

Answer 3

1. Class I (low risk, self declare, if conforming to ISO9001)
2. Class IIa (self declare) and IIb (cannot self declare) (medium risk)
3. Class III (high risk, cannot self-declare)

Question 4

What is the MHRA?

Answer 4

The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. (processes registration)

Question 5

What is exempt from the MDD?

Answer 5

Custom made devices e.g. shield/mould.. must have appropriate documentation, risk assessment e.t.c