2018-07

The European Commission has issued two valuable factsheets concerning the new Medical Devices Regulation (MDR 2017/745/EU and the In-vitro Diagnostic Medical Devices Regulation (IVDR 2017/746/EU)

The factsheets can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2018-04

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.21. Rugby helmet
1.22. Autopsy saw
1.23. UV flow germicidal lamp
1.24. Water filter

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.22. Bone void fillers containing animal growth factors
4.23. Weight management products

8. CLASSIFICATION
8.30. Whole body and partial body cryotherapy chambers

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2017-12

The European Commission has updated its manual on borderline and classification.

It includes now:

1. MEDICAL DEVICE/IN VITRO DIAGNOSTIC MEDICAL DEVICE
1.19. Products intended to reduce the effect of alcohol
1.20. Radiation shields

4. BORDERLINE MEDICAL DEVICE – MEDICINAL PRODUCT
4.20. D-mannose for the prevention of urinary tract infections
4.21. Solution of 8-MOP in extracorporeal photochemotherapy

6. BORDERLINE MEDICAL DEVICE –COSMETIC PRODUCTS
6.2. Alum styptic pencils

7. ACCESSORY TO A MEDICAL DEVICE OR AN IN-VITRO DIAGNOSTIC MEDICAL DEVICE
7.5. Microplate washers

8. CLASSIFICATION
8.26. Tissue expanders used in the breast
8.27. Dura guard for use with a craniotome
8.28. Heart bypass cannulae
8.29. Liquid nitrogen for cryopreservation of cells and tissues of human origin for medical purpose

9. SOFTWARE AND MOBILE APPLICATIONS
9.7. Mobile application for managing pictures of moles
9.8. Mobile application for the assessment of moles

The manual can be downloaded here: library

Source: http://ec.europa.eu/growth/sectors/medical-devices_en

2017-05

The European Commission has officially published the in vitro medical device Regulation (IVDR) on the 5th of May, 2017.

The Regulation may be found in our library

IVDR 2017/746/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU

Transition:

The official timing for transition start 20 days after the new law is published in the Official Journal. Publication was on May 5th 2017, which means an official transition starting date on May 25th 2017. The Regulation will be fully applicable in five years for in vitro medical devices.

2017-05

The European Commission has officially published the medical device Regulation (MDR) on the 5th of May, 2017.

The Regulation may be found in our library

MDR 2017/745/EU:
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Transition:

The official timing for transition start 20 days after the new law is published in the Official Journal. Publication was on May 5th 2017, which means an official transition starting date on May 25th 2017. The Regulation will be fully applicable in three years for medical devices.

2016-07

European CommissionThe European Commission has updated the MEDDEV concerning Software. The document has been released on July 15, 2016.

The purpose of this document is to define the criteria for the qualification of stand alone software, when used in healthcare setting, as a medical device and the application of the classification criteria to such software.
This document only deals with stand alone software and provides some  illustrative examples.
Software incorporated in medical devices is outside the scope of this guideline.
The criteria specified in this document apply also to mobile applications.

The document may be downloaded in our library

2016-07

The European Commission has updated the MEDDEV concerning Clinical Evaluations. The document has been released on July 1, 2016.

The document may be downloaded in our library

2015-07

On July 10, 2015 the EU Commission has published some new / updated harmonized standards for the 93/42/EEC (MDD).

Product, which conform to harmonized standards, are presumed to comply with the essential requirements in the Medical Device Directives.

All harmonized standards you may find here: Link

The European Association of Medical Devices of Notified Bodies (Team NB) has issued version 3.3 of the Code of Conduct for Notified Bodies.

The Code of Conduct is a voluntary code to improve harmonised implementation of the European directives, creating a more level playing field for manufacturers.

At the moment the Code of Conduct version 4.0 is in progress and planned for the near future.

The new Code of Conduct you may download in our library

Source: http://www.team-nb.org

2014-07

RoHS 2 is an update to the European Directive 2002/95/EC that limits the use of certain specified hazardous substances to be placed on the EU market from 1st January 2006. The new RoHS Directive 2011/65/EU (RoHS 2) became effective on 3 January 2013. RoHS 2 deals with the same hazardous substances and the same maximum concentration limits as Directive 2002/95/EC (RoHS 1).

The Directive shall apply to medical devices which are placed on the market from 22 July 2014. There is an extended transition period for in vitro diagnostic (IVD) equipment (until 22 July 2016).

Those affected by this Directive are producers of Electrical and Electronic Equipment (known as EEE). They must ensure that their products and the components of such products comply with the requirements of the Directive.

CEpartner4U may act as your Authorized Representative according the RoHS Directive. If you are interested in this service, please contact us directly.