Regulatory

Medical Device Regulation

Medical devices have become an increasingly important health care area in relation to their impact on health and health care expenditure. The sector covers some 8000 types of products, ranging from simple bandages and spectacles, through life maintaining implantable devices, equipment to screen and diagnose disease and health conditions, to the most sophisticated diagnostic imaging and minimal invasive surgery equipment.

The European Community's involvement concerns mainly the regulatory framework for market access, international trade relations and regulatory convergence, and the competitiveness of industry. More information can be found on the Industry and Enterprise web site - Medical Sector

The following European Directives regulate the marketing and putting into service of medical devices

Directive 2007/47/EC of the European Parliament and of the Council of 5

September 2007 amending Council Directive 90/385/EEC on the approximation of the

laws of the Member States relating to active implantable medical devices, Council

Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the

placing of biocidal products on the market.

Active Implantable Medical Devices (AIMDD) - Directive 90/385/EEC - OJ L189/ 20.7.90
Medical Devices Directive (MDD) - Directive 93/42/EEC - OJ 169/ 12.7.93
In Vitro Diagnostic Directive (IVDD) - Directive 98/79/EC - OJ331/ 7.12.98

Useful Links

http://www.cen.eu/cen/Members/Pages/default.aspx

http://ec.europa.eu/health/medical-devices/index_en.htm

http://ec.europa.eu/health/medical-devices/links/contact_points_en.htm

These three Directives

Deal with the free movement of Medical Devices in the European Union (27 Member States) and the 4 countries of the European Free Trade Association: Iceland, Liechenstein, Norway, and Switzerland. (EFTA); Member States have retained national competence for other areas, such as reimbursement policy, health policy infrastructures, patient's medical care.

define the essential requirements that devices must meet before being placed on the market, establish conformity assessment procedures and create mechanisms available to national competent authorities to manage implementation or to intervene on the market when reasons of public health so require; they are based on the New Approach and, thus, contain provisions on conformity assessment procedures involving Notified Bodies and Harmonized Standard elaborated by CEN, CENELEC or ETSI, providing a presumption of conformity with the Directives' essential requirements.

have been transposed into the national laws of the Member Sates, and in the EFTA countries. Candidate Countries must fully transpose and implement EU legislation in the framework of their accession to the Union.
can be complemented by other implementing measures , such as Common Technical Specifications in relation to IVDs, reclassification measures, and measures based on the precautionary principle.

Guidelines relating to medical device directives can be found on the Enterprise and Industry website

Sterile Barrier systems are considered to be ‘accessories’ to medical devices as defined under the Meical Device Directive MDD i.e. ‘an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device’.

The Directives concerning medical devices are based on the principles of the New Approach. Read more about the New Approach at http://www.newapproach.org/index_en.htm. Under this approach, the Directives define the essential requirements that devices have to meet when they are put on the market or put into service. Requirements relate to issues such as risk assessment and risk management. In order to facilitate compliance with the essential requirements, the Directives foresee recourse to harmonised European standards. Where reference of these standards has been published in the Official Journal, compliance with such standards provides presumption of conformity with the relevant essential requirements. Whilst the essential requirements are obligatory, the standards remain voluntary. Follow the link for a summary list of titles and references of harmonised standards related to medical devices.

CEN is the European Committee for Standardization. The CEN Technical committee CEN/TC102 drafts standards that address the Essential Requirements of EU Directive 93/42/EEC and EU Directive 90/385 as they apply to sterilizers, wash-disinfectors and their associated accessories in order to ensure sterilisation and sterile products. Sterile Barrier Systems fall into this category. A list of the standards published by this committee can be found by following the link CEN Published Standards .

For a more detailed overview follow the link

Members of the SBA use the published standards to demonstrate conformity of their products with the essential requirements of EU Directive 93/42/EEC.