http://iet.metastore.ingenta.com
1887

EU MDD 93/42/EEC

EU MDD 93/42/EEC

For access to this article, please select a purchase option:

Buy chapter PDF
£10.00
(plus tax if applicable)

IET members benefit from discounts to all IET publications and free access to E&T Magazine. If you are an IET member, log in to your account and the discounts will automatically be applied.

Learn more about IET membership 

Recommend Title Publication to library

You must fill out fields marked with: *

Librarian details
Name:*
Email:*
Your details
Name:*
Email:*
Department:*
Why are you recommending this title?
Select reason:
 
 
 
 
 
Engineering High Quality Medical Software: Regulations, standards, methodologies and tools for certification — Recommend this title to your library

Thank you

Your recommendation has been sent to your librarian.

Council Resolution 85/C 136/01 of the May 7, 1985 defined the so-called “new approach” to technical harmonization and standards with the aim of removing barriers to trade and facilitating the free movement of goods within the European Union (EU). In the health-care domain, the effect of such a resolution had been the definition of a legal framework for medical devices that consists of three directives: (1) Council Directive 90/385/EEC on Active Implantable Medical Devices (1990) [7]; (2) Council Directive 93/42/EEC on Medical Devices (1993) [8]; and (3) Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices (IVDMD) (1998) [9]. Therefore, such a legal framework had been originally conceived in order to “remove barriers to trade and facilitate the free movement of medical devices.” The effort of harmonization, however, had resulted in the definition of a set of common requirements for safety, which had previously been defined separately by the Member States.

Chapter Contents:

  • 2.1 Background
  • 2.2 Content of the Directive 93/42/EEC
  • 2.3 The approval process for software as a medical device
  • 2.3.1 Qualification
  • 2.3.2 Classification
  • 2.3.2.1 Software as active therapeutic medical devices
  • 2.3.2.2 Software intended for diagnosis or therapy
  • 2.3.2.3 IVDD and software in conjunction with in vitro diagnostic devices
  • 2.3.3 Selection of the Authorized Representative and notified body
  • 2.3.4 Implementation of a quality management system
  • 2.3.5 Documenting software as a medical device
  • 2.3.6 Auditing by the notified body
  • 2.3.7 Display of the CE marking

Inspec keywords: software standards; health care; medical computing

Other keywords: EU MDD 93/42/EEC; technical harmonization; legal framework; health-care domain; Council Directive 93/42/EEC; European Union; in vitro diagnostic medical devices; Council Directive 98/79/EC; active implantable medical devices; Council Directive 90/385/EEC; IVDMD; Council Resolution 85/C 136/01; standards

Subjects: Biology and medical computing

Preview this chapter:
Zoom in
Zoomout

EU MDD 93/42/EEC, Page 1 of 2

| /docserver/preview/fulltext/books/he/pbhe012e/PBHE012E_ch2-1.gif /docserver/preview/fulltext/books/he/pbhe012e/PBHE012E_ch2-2.gif

Related content

content/books/10.1049/pbhe012e_ch2
pub_keyword,iet_inspecKeyword,pub_concept
6
6
Loading
This is a required field
Please enter a valid email address