The European Union in 2008 and a Review of CE Marking

By Evangeline Loh

The champagne flutes have been washed and returned to their respective places on the shelves and already are accumulating dust, and the New Year’s resolutions established and broken. Therefore, it is now appropriate to take a moment to review CE marking in 2008. Some of the topics that follow will be covered in more detail in this column as the year progresses, but for now, this column will address the following questions: Is the European Union truly developing into one internal market, or is it reverting into individual national states with their own national laws and requirements? And, are we abandoning one of the four principles of the internal market, free movement of products?

Before we look at CE marking in Europe, bear in mind the following facts: The European Union boasts 27 member states (official ascension of Bulgaria and Romania occurred in January 2007), a population of 490 million and, at last count, 23 languages. Furthermore, as it relates to medical devices, Norway, Lichtenstein, Iceland and Switzerland are additional countries that have transposed European laws into their national legislation. Add to that EU candidate member states, and there is a tremendous marketplace for medical devices that must possess CE marking in the European Union. In fact, Turkey, an EU candidate member state, has transposed the Medical Devices Directive MDD 93/42/EEC.

Now, let’s move on to the main topic.

CE Marking  

 

Does CE Marking really imply “conformance throughout Europe”? Council Resolution of 1985 (May 7), titled New Approach to Technical Harmonization and Standards, was the European Union’s technique to remove barriers to the free circulation of certain products. The 21 New Approach directives describe products subject to CE marking. The three medical device directives are part of the New Approach: MDD 93/42/EEC; Active Implantable Medical Devices Directive AIMDD 90/385/EEC; and In Vitro Diagnostic Directives IVDD 98/79/EC. These directives define essential requirements and (for medical devices) characteristics such as risk assessment and safety to patients. In addition, chemical physical and biological properties, etc. are delineated, but the directives do not necessarily proscribe specific technical requirements to permit flexibility, innovation and development of the device. (It was envisioned that European harmonized standards published in the Official Journal of European Communities would facilitate compliance with essential requirements, as compliance with such standards presumes compliance with the relevant essential requirements.)

Devices that meet the applicable essential requirements and have undergone the appropriate conformity assessment routes will be granted CE marking. It is a common misconception that CE marking is a distinction of quality or a mark of consumer assurance. In reality, the CE marking is an attestation by the manufacturer of compliance with the appropriate New Approach directives’ requirements.   

One should note that while a product may be subject to multiple New Approach directives, the Medical Devices Directive (MDD) is a specific directive and takes precedence over the other directives. For example, medical devices subject to both the MDD 93/42/EEC and the Electromagnetic Compatibility Directive EMC 2004/108/EC possess CE marking to the MDD but still are subject to the relevant provisions of the Electromagnetic Compatibility Directive. Medical devices that also are machinery, as defined by the Machinery Directive 2006/42/EC, are CE marked to the MDD; however, where relevant hazard exists, they also must meet the essential health and safety requirements relating to the design and construction of machinery (Annex I, Machinery Directive) when the requirements are more specific than essential requirements (Annex I in the MDD).

Regulatory Documentation and Notified Body Involvement

The regulatory documents compiled to demonstrate that the medical devices are in compliance with the requirements of the MDD are called technical files and design dossiers. Typically, technical files are compiled for Class I, Class IIa and Class IIb medical devices; design dossiers are drafted for Class III medical devices.

One of the activities of the Global Harmonization Task Force (GHTF) Study Group 1 is a harmonized technical document used to describe how the device was developed, designed and manufactured and also demonstrate how the device meets the Essential Principles of Safety and Performance of Medical Devices. This format, termed Summary Technical Documentation, was developed and published in a GHTF guidance document in hopes of harmonizing the regulatory requirements between different jurisdictions. The STED and evaluation of its effectiveness is still a work in progress.

Manufacturers self-certify Class I non-measuring and non-sterile devices, which implies that notified body involvement is not required. Class I sterile and measuring, Class IIa and Class IIb devices require notified body interaction, as do Class III devices. Notified body engagement is designated by a CE marking with a four-digit notified body number (individual identifier) beside it. It is obvious from Directive 2007/47/EC that the notified body will be required to more vigorously review technical files for Class IIa and Class IIb medical devices.

Is CE Marking the Passport to the EU?

Entities conducting business in Europe have observed increasing challenges with selling medical devices that have the CE marking. The MDD originally required manufacturers of Class I devices to register the device in the member state in which they were based or, if not established in the European Union, in the member state where their European authorized representative was based. The MDD provided latitude when member states transposed the directive into their national law to require notification for Class IIb and Class III devices. Obviously, certain member states required that Class IIb and Class III devices be registered.

Directive 2007/47/EC, which amends the MDD. now allows member states latitude when they transpose the directive to include Class IIa devices in the registration requirements. Considering the regulations and national laws, some member states don’t appear to be adhering to the directive—in fact, some regulatory authorities in Italy have flagrantly disobeyed the directives and required registration of all classes of devices, Global Medical Devices Nomenclature (GMDN) codes, VAT numbers and detailed information about the devices, though the inclusion of Class IIa devices to the litany of information that may be requested by member states accomplishes the same objective.

A Lesson From Shakespeare

“What is in a name? That which we call a Rose by any other name would smell as sweet.”

When William Shakespeare wrote that line for Juliet, and she expressed to Romeo that names were meaningless and artificial conventions, they certainly were not referring to the emphasis being placed on the GMDN. It has become apparent that one of the barriers to marketing in Europe may become the GMDN codes, if the codes become a requirement for national registration without easy access to them and a transparent process to develop new codes. This may be an even greater challenge when the European database, Eudamed, becomes functional.

Vigilance Reporting

The MEDDEV 2.12.1 Rev. 5 seems to be harmonizing the vigilance reporting timeframes, though it is not evident if this will be true for all member states. Several member states have begun to acknowledge MEDDEV 2.12.1, Rev. 5 as the guidelines that they will follow and have used the electronic forms for incident reports and field safety corrective action (FSCA) reports. National competent authorities—inspired by the activities of the GHTF SG2, National Competent Authority Report Exchange Program—have been communicating and exchanging more information with each other.

Refuse and Refrain From Certain Substances

Several directives that have become mandatory over recent years highlight the importance of the environment to the European Union: Directive on Packaging and Packaging Waste Directive 94/62/EC; Directive on Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC; Directive on Batteries and Accumulators and Waste Batteries and Accumulators Directive 2006/66/EC; Directive Relating to the Restrictions on the Marketing of Certain Measuring Devices Containing Mercury, Directive 2007/51/EC; and, the preamble to Directive 2007/47/EC, discussing phthalates and carcinogenic, mutagenic or toxic substances in medical devices. Directive 2006/66/EC must be transposed by Sept. 26, 2008, and establishes rules regarding the placing on the market of batteries and accumulators and rules for the collection, treatment, recycling and disposal of waste batteries and accumulators. Directive 2007/51/EC must be transposed by Oct. 3. These directives have been transposed into national laws and have created major challenges to the free movement of products within the European Union by imposing complicated national registrations.


This intent of this particular column has been to provide a rudimentary review—as well as an editorial—of various topics that are viewed as important in the upcoming year. While it may be March, it is never too late to wish everyone a happy and successful European experience in 2008.

Evangeline Loh, PhD, RAC is director regulatory affairs of Emergo Group, a consulting firm that provides quality assurance, regulatory affairs and distribution services. Emergo Group has offices in the United States, Europe, Canada and Australia. Evangeline can be reached at [email protected].