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  • Welcome to gainspeed Ltd,

    CE Marking Specialists


    A South Wales based Product  Certification and training company, specialising in supporting small to medium enterprises in meeting their CE Marking obligations


  • Specialists in EMC and Low Voltage

    (Safety) Directives


    We specialise in European and Worldwide approvals.

  • Flexible, Professional, and Affordable Service


    We are a small organisation employing only

    highly experienced associates.

Category: News

New OJ List of Harmonised standards for MD Directive now published

Base: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
OJ L 169 of 12 July 1993
Modification:
  • Directive 93/68/EEC [CE Marking]
  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
  • Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma
  • Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning 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

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Our July 2015 Newsletter packed with latest Compliance news!

Your free comprehensive guide, perfect for saving you time.

Were very proud to announce the Gainspeed news letter is here. Its a friendly complimentary newsletter on everything compliance.

Some of this months features.

  • New directive numbers
  • New Lists of Harmonised Standards
  • RoHS Directive changes
  • Changes to standards and EU Directives
  • A Compliance Calendar to plan for your future.
  • Links to find all the information you need
Posted in News, News Letter |