New Year, New Details of European Regulatory Changes Ahead

This article first appeared in Medical Products Outsourcing in January 2012.

Regarding revisions to the European Union’s medical device regulations, 2012 is off to a vigorous start. As the new year begins to take shape, it would be constructive to both highlight major EU regulatory developments occurring in 2011 as well as identify major issues likely to impact the European medical device market in 2012.

The year that Was: 2011 Events and the Future of EU Regulation
The major European medical device regulatory developments of 2011 provide a good indication of where the EU Commission will direct their efforts in 2012. As Emergo Group has previously reported in MPO, improving Europe’s Notified Body system received lots of attention last year—not only from regulators, but also from the Notified Bodies themselves. Regulators have strongly hinted that a revamped Notified Body system will be included in any revision of the Medical Device Directives, and Notified Bodies in turn published their own voluntary code of conduct in 2011 to demonstrate good-faith effort to improve their performance. Whether Notified Bodies’ code of conduct will allay regulators’ concerns or be discarded in favor of more rigorous EU requirements remains to be seen, but could be resolved this year.

The EU Commission also indicated in late 2011 that they are considering revising the Medical Device Directives as regulations rather than directives; such a move would obviate the need for transposition by each EU Member State. However, taking a regulatory tack would open up the revision process to significant scrutiny by the European Parliament and the EU Council. This approach may help avoid many of the current regulatory inconsistencies across Member States that have arisen from differences in national transpositions of the existing Directives. Either way, there will be no short cut to reform.

First MDEG Meeting of 2012
Most recently, on January 10, the EU Commission’s Medical Device Expert Group (MDEG) held a meeting in Brussels that produced revisions to major MEDDEV documents, as well as new stand-alone software, In Vitro Fertilization and Assisted Reproduction Technology (IVF/ART), and Authorized Representative guidelines.

MEDDEV 2.12.1, Rev. 7: Medical Devices Vigilance System Guidelines
The meeting yielded updated guidelines for a European Medical Device Vigilance system (MEDDEV 2.12-1 rev.7) including an XML format for Field Safety Corrective Action Reports.

  • Templates for Manufacturers Trend Reporting and Manufacturers Periodic Summary Reporting are also included in this guidance; these templates are based on Global Harmonization Task Force (GHTF) documents, demonstrating the EU’s ongoing commitment to GHTF principles.
  • The Medical Device Vigilance System guidelines emphasize issues such as use error during evaluation of criteria that may constitute an incident, as well as provide examples of Field Safety Corrective Action reports (Annex 1) and how to further involve users in the vigilance process (Annex 11).
  • Furthermore, guidelines for reporting incidents to regulatory authorities in Turkey have been included for manufacturers active in that market.
  • Guidelines also expand IVD classification criteria to include devices not used directly on patients, as well as IVF/ART.
  • Additional requirements for Competent Authorities to use the EUDAMED database for exchanging National Competent Authority Reports (NCARs) in order to provide better coordination with Commission Decisions.


MEDDEV 2.12.2, Rev. 2: Post Market Clinical Follow-Up Study Guidelines
The January MDEG meeting also dealt with amendments to post market clinical follow-up (PMCF) that were stipulated by Directive 2007/47/EC. Revised PMFC guidelines address the monitoring of long-term risks that may not be immediately apparent for some medical devices, recommending when PMCFs are warranted; general principles of PMCFs; proper use of clinical study data; and the PMCF role in Conformity Assessment Procedures.

MEDDEV 2.5.10, Rev. 1: Authorized Representative Guidelines
Also issued during the MDEG meeting were finalized guidelines for Authorized Representatives (AR) (MEDDEV 2.5.10, Rev. 1), Guideline for Authorized Representatives. Intended to clarify AR roles and responsibilities within the EU medical device regulatory regime, the guidelines define EU Member States’ expectations of ARs and strongly recommend use of written contracts between ARs and the manufacturers they represent in order to clearly delineate responsibilities carried out by ARs (such as AR Agreements).

The guidelines also emphasize that device manufacturers and their ARs must make every attempt to keep one another informed of all issues related to products they have commercialized in the EU. Expectations that Member States receive all information they request from ARs is made clear in the guidelines; accordingly, manufacturers must ensure that all device data they possess internally is made available to their ARs.

MEDDEV 2.2.4: IVF/ART Conformity Assessment Guidelines
MEDDEV 2.2.4
Conformity Assessment guidelines for IVF/ART devices apply PMCF, traceability and vigilance principles to these increasingly popular products in accordance with Directive 93/42/EEC. EU regulators considered guidance for IVF/ART devices necessary because safety issues may not arise until months or years after use of such a device. Furthermore, the guidelines list risks specifically tied to use of IVF/ART devices.

MEDDEV 2.14.1, Rev. 2: IVD Medical Device Borderline and Classification Revisions
The January MDEG meeting also saw a substantial revision of MEDDEV 2.14.1 dealing with IVD classification—now a 21-page document, from eight pages in its previous iteration. Now MEDDEV 2.14.1 more closely resembles guidance on the classification of medical devices (MEDDEV 2.4.1, Rev. 9). Specific IVD products and components covered in the guidance include:

  • Specimen receptacles
  • Products to obtain specimens
  • General laboratory use products
  • IVD kits
  • Microbiological culture media
  • Stains
  • Devices requiring invasive body contact with no IVD purpose


Also included in the revised MEDDEV 2.14.1 are classification issues concerning some IVD products in Annex II, Lists A and B of 98/79/EC.

Healthcare software guidelines
Following two years’ worth of development, guidelines covering qualification and classification of software for healthcare applications related to medical devices were also released as part of the MDEG meeting; these guidelines address software for the following uses:

  • Software used as an active therapeutic medical device
  • Software used for diagnosis or therapy
  • Software related to in vitro diagnostic devices

The guidelines address software commonly used in platforms including Hospital Information Systems, Telemedicine systems, medical data monitoring systems as well as IVD software—Laboratory Information Systems, Work Area Managers and Expert Systems.

According to the guidelines, stand-alone software may be classified either as an active medical device under 93/42/EEC or as an IVD under 98/79/EC.

At the writing of this column, many of the above described MEDDEVs were not formally published. However, we will certainly provide updates in upcoming months. Beyond these developments, the EU Commission has planned meetings for February 6 and 13 focused on revisions to medical device legislation, which should shed more light on how European medical device regulations will change. We certainly look forward to many regulatory changes in the EU in 2012!

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