How Will Europe’s Amended Device Directives Change Your Approach?

By Evangeline Loh

In late September, the long-anticipated revisions to the Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) were published in Directive 2007/47/EC. (This new directive also amends the Biocidal Directive 98/8/EC.) Those who lament memorizing numbers may be grateful, because no consolidated text replacements were issued. The MDD and AIMDD will remain with their originally issued monikers. The laws, regulations and administrative provisions necessary to comply with this directive should be adopted and published by Dec. 21, 2008. And, the measures should be applied beginning March 21, 2010.

The following discussion describes the changes delineated in Directive 2007/47/EC as well as how these changes modify the MDD and AIMDD.

Device Definitions More Well Defined

The MDD and AIMDD define a medical device more explicitly to include software as a category. An additional point in the stated purpose of a medical device was added to the AIMDD to align it with the purposes of medical devices as described in the MDD. Four definitions were added to Article 1 of the MDD: clinical data, device subcategory, generic device group and single-use device. Two definitions were added to Article 1 of the AIMDD, authorized representative and clinical data. Furthermore, three of the definitions in the AIMDD were modified to reflect the definitions provided in the MDD: custom-made device, device intended for clinical investigation and intended purpose.

Combination Products Delineated

Both the MDD and AIMDD emphasize that the principal mode of action is the characteristic used to distinguish whether the product should be classified as a device or drug. When a device is intended as both a medical device and personal protective equipment (PPE, Directive 89/686/EEC), the MDD and relevant basic health and safety requirements of the PPE also must be fulfilled. Medical devices and active implantable medical devices that also are machinery, as defined in the directive on machinery (2006/42/EC), are subject to the MDD and AIMDD, respectively—as well as the essential health and safety requirements in Directive 2006/42/EC. Medical, active implantable and in-vitro diagnostic devices are excluded from the biocidal directive.

Clarification on Single-Use Devices and Reprocessing

In the MDD, “single use” is explained as a device used once on a single patient. In the Essential Requirements (Annex I of the MDD), a manufacturer’s indication that a device is a single-use device must be consistent in the European communities and, obviously, must be labeled consistently. The information on characteristics and factors that pose a risk if single-use devices were to be reused should be published in the manufacturer’s labeling section on instructions for use (IFU). If an IFU isn’t provided, this information must be provided if someone requests it. On the issue of the reprocessing of medical devices, the MDD requires the European Commission to submit a report to the European Parliament by Sept. 5, 2010, for further consideration.

Administrative Modifications

The provision that permitted member states the option to request label and IFU information on Class IIb and Class III devices was extended to include Class IIa. A manufacturer that does not have a registered place on business in a member state shall designate one Authorized Representative for the device or family of devices. The European databank is expanded to include information about the authorized representative and clinical investigations. The European databank must be implemented by Sept. 5, 2010. Documents related to implantable devices need to be retained for at least 15 years. The Declaration of Conformity must clearly identify the device by product name, product code or unambiguous reference and must be kept by the manufacturer.   

Directive Annexes  

In the MDD, the first Essential Requirement is clarified to extend to design considerations for patient safety due to ergonomics and for users based on their knowledge, experience, education, training as well as medical and physical condition. In both directives, a requirement is added that software must be validated according to the state of the art. The date of issue or the latest revision must be posted on the IFU for both medical and active implantable devices. The considerations, requirements and procedures for a notified body reviewing a device that incorporates, as an integral part, a substance that, if used separately, is a medicinal product, according to the medicinal product directive, is more thoroughly described in both the MDD and AIMDD.

Noteworthy MDD Changes

Notified body review of the technical documentation for Class IIa devices is more thoroughly delineated—the notified body must review at least one representative sample for each device subcategory. For Class IIb devices, the notified body must see one representative sample for each generic device group. This most likely will trigger a greater time involvement by the notified body and, therefore, increased notified body fees. Manufacturers of Class I sterile or measuring devices have the option of using the full quality conformity assessment. A manufacturer that uses subcontractors to design and/or manufacture its device must demonstrate sufficient monitoring and efficient operation of the quality system, as well as adequate control of the subcontractor.

MDD Classification Changes, Annex IX, Classification Criteria

A definition of continuous use of a device is provided as “uninterrupted actual use for the intended purpose or use of the device discontinued only for immediate replacement by the same or identical medical device.” Getting more specific, the central circulatory system is extended to the arch of the aorta and descending aorta. Invasive devices with respect to body orifices connected to active Class I devices now are included in the classification as well. Medical devices in direct contact with the central nervous system are categorized as Class III. Devices intended to disinfect invasive devices are in Class IIb.

Emphasis on Clinical Data

Both directives are modified to place a greater emphasis on clinical data and evaluations. Clinical data are defined as “the safety and/or performance information generated from use of the data, derived from clinical investigations of the device, clinical investigations reported in the scientific literature, and reports on clinical experience.” A requirement—6a and 5a—was added to the Essential Requirements of the MDD and AIMDD, respectively, that “Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with” the appropriate section, Annex X for MDD and Annex 7 for AIMDD. Annexes II, III and VII of the MDD are revised to reflect the clinical evaluation in accordance with Annex X. In Annex X and Annex 7, there is a stipulation that the clinical evaluation must follow a defined and methodologically sound procedure, and the MDD deletes the reference that particularly implantable devices and Class III devices require clinical data. It is expected that clinical evaluations will be expected of even low-risk devices, including Class I devices. Many Class I and Class IIa medical device manufacturers will have to add clinical evaluations to their current technical documentation.


Directive 2007/47/EC amends the MDD and the AIMDD. It has been a long awaited directive, but the circulated draft versions appear to have adequately prepared the community for the changes.

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].