Medical Devices

The term 'medical device' covers all products, except medicines, used in healthcare for the diagnosis, prevention, monitoring or treatment of illness or disability.

The IMB is responsible for the regulation of medical devices on the Irish market. The range of products is very wide. It includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames or other assistive technology products; pregnancy tests, blood glucose monitors and pacemakers - many thousands of items used each and every day by healthcare providers and patients.

Medical devices do not include ambulance vehicles, general workshop equipment such as power or machine tools, or general purpose laboratory equipment. Pre-filled devices, for example, drug inhalers, syringes and certain other drug / device combinations are classed as medicines, not medical devices.

There are three types of medical devices outlined in the legislation. They are as follows:

General medical devices
Active implantable medical devices
In-vitro diagnostic medical device

Medical devices are divided into classes dependent on risk which can be low, medium and high risk.

The principle legislation covering medical devices is:

Directive 90/385/EEC concerning Active Implantable Medical Devices (AIMDD)
Directive 93/42/EEC concerning General Medical Devices (MDD)
Directive 98/79/EC concerning In-vitro Diagnostic Medical Devices (IVDs)

The above Directives have been transposed into national law, as follows:

S.I. No. 253 of 1994, European Communities (Active Implantable Medical Devices) Regulations, 1994 that became mandatory on 1st January 1995.
S.I. No. 252 of 1994, European Communities (Medical Devices) Regulations, 1994 that became mandatory on 14th June 1998.
S.I. No. 304 of 2001, European Communities (In-vitro Diagnostic Medical Devices) Regulations, 2001 that became mandatory on the 7th December 2003.

A number of key guidance notes have been prepared to assist the medical device sector on the use of the Directives and related Regulations. In addition a number of application forms have been prepared to ensure that all data required by the IMB is included with correspondence. These documents can be found on the publications section of the website. These forms can also be obtained in the European Commission Guideline on a Medical Device Vigilance System Meddev 2.12-1, rev 6.

There are three sections within the Human Products Authorisation and Registration Department, details of which can be found on the website:

Pre-Market Evaluation Section
Post-Market Evaluation Section
Auditing & Surveillance Section

The IMB encourages communication with the medical device sector. Should you have specific queries please address them to the Human Products Authorisation and Registration Department of the IMB who will endeavour to be of assistance. Please contact us at medicaldevices@imb.ie

The Irish Medicines Board - www.imb.ie

Medical Devices