Medical device CE marking

Publication of MDR


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


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.

Updated MEDDEV-guidance on software


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

New / updated harmonized standards


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

Updated Code of Conduct for Notified Bodies


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


RoHS 2 applicable for Medical Devices per 22 July 2014


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.

New / updated harmonized standards


On May 16, 2014 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.

The updates of horizontal standards, include a.o.:

Ref. Desription In force:
EN ISO 11137-1:2006/A1:2013 Sterilization of health care products – Radiation 2014-11-30
EN ISO 11137-2:2013 Sterilization of health care products – Radiation 2014-11-30
EN ISO 13408-1:2011/A1:2013 Aseptic processing of health care products 2014-11-30
EN 60601-1:2006/A1:2013 Medical electrical equipment 2017-12-31

All harmonized standards you find here:

Medical Devices

In vitro diagnostic Medical Devices

Active Implantable Medical Devices

The ‘new’ Blue Guide


The Guide to the implementation of directives based on the New Approach and the
Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become
one of the main reference documents explaining how to implement the legislation
based on the New Approach, now covered by the New Legislative Framework.

Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to
cover new developments and to ensure the broadest possible common understanding
on implementation of the New Legislative Framework (NLF) for the marketing of
products. It is also necessary to take account of the changes introduced by the
Lisbon Treaty (in force since 1st December 2009) with regard to the legal references
and terminology applicable to EU-related documents, procedures, etc.

This new version of the Guide will therefore build on the past edition, but include new
chapters, for example on the obligations of economic operators or accreditation, or
completely revised chapters such as those on standardisation or market surveillance.
The Guide has also been given a new title reflecting the fact that the New Legislative
Framework is likely to be used, at least in part, by all types of Union harmonisation
legislation and not only by the so-called “New Approach” directives.



New guidance on Software


A final document has been released on December 9, 2013 by the International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD).

This document contains various key definitions which focus on a common definition for when software is considered to be a medical device and a reminder of other key terms.

The document may also be downloaded in our library.