Medical Device Directive 93/42/EEC

Community-wide regulation of medical devices commenced with the introduction of Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices. Two further base directives followed that cover all other medical devices The Medical Devices Directive 93/42/EEC and The In Vitro Diagnostics Directive 98/79/EC. All three base directives are similar in content and structure. However, it should be noted that, in addition to dealing with the particular subject matter, the Medical Devices Directive and the In Vitro Diagnostics Directive also contained amendments to the previous device directives. The Medical Devices Directive amended articles in the Active Implantable Medical Devices Directive, while the In Vitro Diagnostics Directive amended articles in the Medical Devices Directive. 

The range of devices regulated under the general medical device directive, 93/42/EEC, can vary from the simple devices that pose little or no risk to patient or user health to those that are life-critical. It is neither economically feasible, nor justifiable in practice. 

Medical Devices Directive 93/42 EEC, Article 10 (Competent Authority Vigilance procedure). Article 14 (Manufacturer registration). Annex II 3.1 (i) (ii) manufacturer s vigilance and reporting duties)... 

Medical Devices Directive 93/42/EEC. http //eur-lex.europa.eu/ LexUriServ/LexUriServ.do ijri=CONSLEG 1993L0042 20071011 EN PDF. Accessed 7 Jul 2014... 

Borderline cases are considered to be those cases where it is not clear from the outset whether a given product falls under Medical Device Directive 93/42/EEC (MDD), the Active Implantable Medical Device Directive 90/385/EEC (AIMDD),... 

In 2012, a European harmonized version of this standard was adopted by European Committee for Standardization as EN ISO 14971 2012. This version is harmonized with respect to the three European directives associated with MDs Medical Devices Directive 93/42/EEC, In Vitro Diagnostic Medical Device Directive 98/79/EC, and Active Implantable Medical Device Directive 90/385/EEC. This was done to address the presumed compliance with the three directives that is obtained through notified body certification audits and regulatory submissions that claim compliance to this standard. 

In 1993 the EU issued a directive (European ParUament 2007) which became known as the Medical Devices Directive (MDD). This EU mandate was enacted into UK law in 2002 by the Medical Devices Regulations 2002. These regulations implement the provisions of the Medical Devices Directive, 93/42/EEC. 

EC Amends Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma... 

EC Introduces detailed specifications as regards the requirements laid down in Coundl Directive 93/42/EEC with respect to medical devices manufactured utilizing tissues of animal origin... 

Figure 9.1 Summary of key elements of the Essential Requirements from the medical device directives 90/385/EEC, 93/ 42/EEC and 98/79/EC.

Directive 93/42/EEC on medical devices (MDs) came into force on 1 January 1995 and became mandatory on 14 June 1998. This covers a wide range of devices ranging from first aid bandages, tongue depressors and blood collection bags to hip prostheses and active (powered) devices. 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

Uuited Kingdom Medical Devices Regulations (1994), Regulation 2(1) SI 1994 No. 3017 (this U.K. regulation implements EU Directive 93/42/EEC). 

European Directive 93/42/EEC concerning medical devices — class lib Parts in and V. 

European Council (1993) Directive 93/42/EEC of 14 June 1993 concerning medical devices. 

EMEA (2001) Guidelines relating to the application of the council directive 90/385/EEC on active implantable medical devices the council directive 93/42/EEC on medical devices, MEDDEV 2.1/3 rev 2 (July 2001). 

European Commission. Medical device guidance document. Classification of medical devices. Guidehnes relating to the application of the Council Directive 93/42/EEC on Medical Devices. 2010. 

The Council of the European Communities, Directive 93/42/EEC, Medical Device Directive (MDD), June 1993. 

Gloves intended for protection of the user are referred to in Europe as personal protective equipment and covered by the Personal Protective Equipment Directive 89/686/EEC. However, gloves intended for use in the medical field to protect patients and user from cross-contamination are referred to as medical devices and are covered by Council Directive 93/42/EEC concerning medical devices (Mellstrom and Carlsson... 

Basic information about the European Directive 93/42/EEC on medical devices, www.mdc-ce.de/downloads/040100 06 e.pdf Accessed 16 Mar 2013... 

Probably the greatest potential differences between CTD and MD dossiers are linked to modules 3 and 4 of the CTD. To properly analyze the differences, however, we must take into accoimt the evolution of the concept of medical device. Today there are objects that can be classified as MDs that cordd not be considered so by those who drafted the initial definition, and who listed the content of the TF required by Directive 93/42/EEC. 

Thus, the EU, in particular, develops a series of interpretative guidelines [28] to help manufacturers in the correct implementation of the requirements of Directive 93/42/EEC in particular, the context of MD applies to guideline MEDDEV 2.1/3 MEDICAL DEVICES Guidance document—Borderline products, drug-delivery products and medical devices incorporating, as an integral part, an ancillary medicinal substance or an ancillary human blood derivative. ... 

Directive 93/42/EEC (and following amendments) concerning medical devices. 

Directive 93/42/EEC, which covers the placing on the market and putting into service of medical devices... 

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