The Medical Devices Directive (93/42/EEC) was transposed into Irish law via the European Communities (Medical Devices) Regulations, 1994, and became fully mandatory on 14 June 1998. The directive forms part of an overall drive to complete the single market in Europe and lays down essential requirements for the manufacturing of medical devices and the procedures for checking that all products comply with them. Devices meeting these requirements are entitled to bear the “CE” marking and may be placed on the Community market without further restrictions.
The directive groups medical devices into three broad categories: low risk, medium risk and high risk, depending on the perceived risk associated with the devices. Manufacturers of medium and high risk devices, such as catheters or heart valves, must be assessed by what is called a "notified body" before they can place their devices on the market. Manufacturers of low risk devices which have a very small chance of seriously injuring patients, such as crutches or spectacles, can place their devices on the market without recourse to a notified body.
The directive is primarily aimed at regulating the manufacture of medical devices. A manufacturer is defined in the directive as the person responsible for defined activities relating to a device with a view to it being placed on the market under his or her own name. The reason for the link with the placing on the market of the device is that the aim of the directive is to subject to its requirements the passing of a product from a manufacturer to a final user by way of change of ownership in a commercial transaction. In the normal course of events the medical devices which are used on patients in our hospitals are normally purchased by the hospitals concerned after they have already been placed on the market by their manufacturers. Therefore, hospitals are not normally considered to be manufacturers of medical devices and the question of them complying with the directive does not usually arise, although there can be a small number of exceptions to this rule where, in certain circumstances, hospitals could be considered to be manufacturers of medical devices within the scope of the directive.
For example, where a hospital sterilises a medical device and makes it available to another hospital, which is a separate legal entity, it is considered that this would be placing it on the market if a change of ownership takes place.
Additional InformationIn this case the hospital which sterilises the device would be considered as the manufacturer and would have to adhere to the appropriate provisions of the directive. On the other hand, where a hospital sterilises a device and it is used only within the hospital's environment, it would not be considered to have been placed on the market. Similarly where a hospital sterilises devices on behalf of a second hospital but no change of ownership takes place, the devices would not be considered to have been placed on the market and the directive would not apply.
Regardless of whether hospitals which sterilise medical devices are within the scope of the directive, the management of the hospitals have an important role to play in ensuring the devices which are used in their hospitals are safe for patients. They can do this in the first instance by ensuring they purchase only medical devices which have been appropriately CE marked. If they are manufacturing or sterilising medical devices themselves, they should ensure their staff are appropriately trained, follow any relevant standards and that all equipment is properly installed and maintained.
My Department has contacted all health boards and hospitals to inform them about the implications of the directive and, in the first instance, it is up to local management to assess whether any manufacturing activities within the scope of the directive take place in their areas. If so, they should comply appropriately.
The directive is one of what are commonly called the "new approach directives", which also regulate other areas such as machinery, telecommunications equipment and toys. The new approach directives contain certain basic concepts which are the key to their harmonised, effective application across the European Union.
As a result of the decision by the European Union to use standards in the new approach legislation, standards play an important part in the conformity assessment procedures which manufacturers must follow before they can place their devices onto the market. The European standards bodies, CEN and CENELEC, have been mandated by the European Commission to produce the relevant standards to support the directives and member states are obliged to adopt these harmonised standards once they are issued. Having said this, however, adherence to standards has always been voluntary and remains so despite the advent of the directive. That is, when a manufacturer is endeavouring to show that his devices meet the essential requirements of the directive, it is not mandatory to comply with any standard. However, in discerning what needs to be done to satisfy the essential requirements, a manufacturer's task will be quicker and easier if he or she shows prior compliance with certain standards. If the pertinent standards are not complied with, the manufacturer must be able to demonstrate an alternative method of showing compliance with the essential requirements of the directive.
I am conscious of the benefits to the health of patients which can be gained by our hospitals adhering to standards. The Deputy will be aware that I recently launched a pilot scheme for hospital accreditation. The accreditation programme will formalise standard setting and measurement across many aspects of a hospital's operations. A notable feature of the general accreditation programme is the relationship which has been established between the major academic teaching hospitals group and the Independent Hospitals Association of Ireland as the representative body for private hospitals in the State. The IHAI and the MATHs group began to develop an accreditation scheme at different times and from different standpoints but are now actively pursuing measures to bring about convergence of their respective endeavours. In this regard, both have agreed to work together on the establishment of a single accrediting body for the Irish health sector.