Category: Medical Devices Directive

Medical Devices Directive

New OJ List of Harmonised standards for MD Directive now published

Updated on

January 31, 2023 by author

Gainspeed

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

New OJ List of Harmonised standards for Active Implantable Devices now published

Updated on

January 31, 2023 by author

Gainspeed

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

Now OJ list of harmonised standards for IVD Directive now published

Updated on

January 31, 2023 by author

Gainspeed

Short name:	In vitro diagnostic medical devices
Base:	Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices OJ L 331 of 7 December 1998

EU MDR & IVDR – Final Versions Released

Updated on

January 31, 2023 by author

Gainspeed

Final texts of the EU MDR & IVDR (R = Regulation) have been released recently, the European Council is scheduled to hold a vote to adopt the legislation in March 2017, followed by a vote in the European Parliament in April. It is estimated that the transition periods will start sometime in the 2nd quarter of 2017. The MDD has a 3 year transition period and the IVDR has a 5 year transition period.

For more information see the original article

https://www.linkedin.com/pulse/eu-mdr-ivdr-final-versions-released-you-ready-leonard-eisner?trk=v-feed&lipi=urn%3Ali%3Apage%3Ad_flagship3_feed%3BXaToH1z2%2BkuzyKhwfUQrYQ%3D%3D

Posted in Medical Devices Directive, News |

New List of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) published in the Official Journal

Updated on

January 31, 2023 by author

Gainspeed

A new list of Harmonised Standards for the Medical Devices Directive, (93/42/EEC) was published in the Official Journal on May 13, 2016 – OJ C 173

9 new standards have been added:

EN 556-2:2015 (new) Sterilization of medical devices – Requirements for medical devices to be designated ”STERILE” – Part 2: Requirements for aseptically processed medical devices
EN 1865-1:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 1: General stretcher systems and patient handling equipment
EN 1865-2:2010+A1:2015 (new) Patient handling equipment used in road ambulances – Part 2: Power assisted stretcher
EN ISO 3826-4:2015 (new) Plastics collapsible containers for human blood and blood components – Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015)
EN ISO 11137-1:2015 (new) Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN ISO 11137-2:2015 (new) Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose (ISO 11137-2:2013)
EN ISO 13408-1:2015 (new) Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
EN ISO 13408-7:2015 (new) Aseptic processing of health care products – Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012)
EN 60601-1-2:2015 (new) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral
Standard: Electromagnetic disturbances – Requirements and tests

Posted in Medical Devices Directive, New Standards/Directives, News |