TWI Frequently asked questions
by Tom Pinto
All Medical Devices (MDs) are required by regulations to
demonstrate product conformity to a notified body; in the UK this
is the British Standards Institution (BSI). Notified bodies are
commercial organisations that assess manufacturers' conformity
to the essential requirements set out in Annex I of the European
Medical Device Directive (93/42/EEC); in March 2010 this was
revised to European Medical Device Directive (2007/47/EC).
Firstly, it is important to classify your MD correctly; this is
covered by Annex IX of Directive 93/42/EEC
There are four main classes:
| Class |
risk generally
regarded as - |
| I |
low |
| IIa |
medium to low |
| IIb |
medium to high |
| III |
high |
CE marking is not an approval nor is it a
certification either by an authority or by a notified body. It is,
instead, the manufacturer declaring that their medical device
conforms to the safety and performance principles of the
Directives.
Manufacturers must register with a Competent Authority; in the
UK this is the Medicines & Healthcare products Regulatory
Agency (MHRA). MHRA has the responsibility for implementing the
provisions of these Directives in the UK. Manufacturers must inform
them of MDs they are intending to place on the market.
Figure 1 below shows there are several routes to
achieving CE marking, these depend on the class of the MD. Most MDs
achieve CE marking through Annex II or VII since these require a
Quality Assessment system rather than testing of each MD or
statistical verification.
| Fig.1. Routes to CE marking |
| |
Further information
TWI provides its Industrial Members with technical support in a broad range of areas including device design; materials selection; reliability; durability; joining and coating methods; and manufacturing procedures. There are over fifteen scientists and engineers with direct knowledge and experience in medical device developments and an extensive range of facilities and other technical specialists supporting TWI's medical sector activities.
Currently, TWI also co-manages the HealthTech and Medicines Knowledge Transfer Network (HTM KTN).
The HTM KTN is funded by UK Government and is dedicated to accelerating innovation and technology exploitation in the broad health industries sector. The HTM KTN provides unique offerings to its members, with benefits arising from one-on-one consultations on specific needs, to the national and international development of technology strategy that influences future finance. The HTM KTN vision is to be recognized as a world class initiator, translator and disseminator of research and knowledge that contributes to excellence in UK science and leads to rapid exploitation for UK economic and clinical benefit.
The HTM KTN website contains extensive information on medical device related activities.
