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Changes in Europe: The New Landscape for Existing Medical Devices

According to the European Commission, nearly 8000 types of products, ranging from simple bandages to diagnostic equipment to life-maintaining implantable devices are governed by the European Union’s (EU) medical devices legislation. The regulatory framework comprises three basic medical device directives that have been amended on a number of occasions since their adoption in the 1990s.

The most recent technical revision to the directive on active implantable medical devices and Directive 1993/42/EEC, commonly referred to as the Medical Devices Directive (MDD), was introduced through Directive 2007/47/EC.1

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The 2007 directive expands the existing definition of a medical device to cover "any instrument, apparatus, appliance, software, material, or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings." The directive also defines a medical device as being used for the purpose of:
 
? Diagnosis, prevention, monitoring, treatment, or alleviation of a disease, injury, or handicap.
? Investigation, replacement, or modification of the anatomy or of a physiological process.
? Control of conception.
On March 21, the modifications to Directive 2007/47/EC will go into effect in the 27 EU member states. The effect of this revision on certain types of medical devices already on the EU market is unclear. However, because the directive introduces a number of important modifications to the current EU regime governing implantable medical devices and devices governed by the MDD, its implications merit close examination and clarification.2 This directive makes no change to the current provisions of the directive on IVD devices.
 
Implications for Current Certificates of Conformity
 
The new requirements introduced by Directive 2007/47/EC will affect all classes of medical devices. In addition, the obligations will require changes to current manufacturing and technical processes for certain types of medical devices. These changes could lead to a modification of the existing certificates of conformity issued by notified bodies (see “New Directive Requirements” at the end of this article).
 
Depending on its classification, a medical device may require a certificate of conformity that is issued by a notified body. This certificate is issued following a conformity assessment of a medical device and its manufacturing process. During the assessment, the notified body, which is selected by the manufacturer, ensures that the relevant legal requirements of the MDD regarding device quality and safety and the manufacturer’s procedure of controls are met. For many medical devices intended for EU marketing, a certificate of conformity is required before the manufacturer can place a CE mark on the device to show its compliance with EU requirements.
 
The provisions of Directive 2007/47/EC are likely to impose new obligations that will have implications for some Class II and Class III devices. However, the directive does not include a transitional period during which medical device manufacturers would be required to implement the obligations. The directive also doesn’t indicate whether existing certificates of conformity will continue to be valid once the changes go into effect or whether modifications are required. Therefore, the changes to Directive 2007/47/EC raise the question of the validity of existing certificates of conformity for those medical devices that are likely to be directly affected by its provisions.
 
The existing MDD requires a manufacturer to inform the notified body that approved the medical device quality system of any plan for substantial changes to the quality system or to the product range covered by an existing certificate of conformity. Such substantial changes will often require a new audit and a modification of the existing relevant certificate of conformity.
 
It appears likely that as a result of the provisions of Directive 2007/47/EC, some device manufacturers will be required to modify their quality system or product range. However, nothing in the directive indicates which changes should be considered substantial. In addition, there aren’t any indications as to whether modifications that are considered substantial changes will affect current certificates of conformity.
 
From a legal perspective, there is an interesting conundrum here. When, as a matter of choice, a manufacturer introduces substantial changes either to its quality system or to its product range, it can be expected to accept the related consequences of such changes for existing certificates of conformity. However, the question arises about what obligations a manufacturer faces when substantial changes to its quality system or product range are imposed by legislation rather than by choice.
 
To suggest that Directive 2007/47/EC requires an existing quality system or product range (as well as related certificates of conformity) to be revised is arguably giving retroactive effect to the legislation in question. However, in the absence of any guidance to the contrary, it might be equally argued that a manufacturer is required to respect obligations imposed by the MDD when these enter into force. This would be the case in relation to products having a potential effect on patient health.
 
Following this line of argument, a manufacturer would be required to ensure that an existing quality system or product range be modified to reflect obligations laid down in Directive 2007/47/EC and that related certificates of conformity be revised by March 21 at the latest. The question is whether this conclusion is correct.
 
The European Commission published an interpretative document concerning the implications of Directive 2007/47/EC on June 5, 2009.3 The document discusses the following five topics:
 
? Compliance of medical devices with the new requirements.
? Evaluation by notified bodies according to the new requirements.
? Certificates issued prior to March 21, 2010.
? Consultation of authorities responsible for pharmaceuticals.
? Overlap with the Machinery Directive 98/37/EC.
 
According to the European Commission, the document “shall guide a uniform practice throughout the EU.” For the purpose of this article, the points most relevant to an examination of the interpretative document will be discussed.
 
Although the document is somewhat arcane on certain points, it is clear that all medical devices that are to be placed on the EU market or put into service after March 21 must immediately comply with the new requirements of Directive 2007/47/EC. From that date, notified bodies must also carry out conformity assessment activities in accordance with the new provisions. For practical reasons, however, some notified bodies have agreed to apply the new provisions to assessments undertaken prior to that date.
 
From a legal perspective, one could argue that a previously issued certificate of conformity should remain valid even if the law on which the certificate is based subsequently changed. Representatives of the competent authorities of some EU member states have stated that, to the contrary, certificates of conformity for devices that do not comply with the new legislation will cease to be valid after February 21, 2010. However, neither member state authorities nor the European Commission have stated this officially.
 
The document distinguishes between medical devices in relation to which changes must be announced when they are significant and active implantable devices for which any modification to the quality system or design should be approved by the notified body. The document underlines that this is the usual regime regarding change control.4,5 
 
It is arguable that medical devices that have been lawfully placed on the EU market in compliance with EU medical device legislation should continue to be marketed without the need for a new certificate of conformity, at least until the current certificate expires. However, following publication of the European Commission’s interpretative document, it is far from clear that this is the correct conclusion.
 
The document notes that new certification will be necessary for medical devices in case of changes to the approved device design or the approved quality system of the manufacturer, whether triggered by voluntary changes or the new requirements introduced by Directive 2007/47/EC. However, it doesn’t clarify whether these obligations will take effect when the existing certificates expire or whether they take effect on March 21 regardless of whether existing certificates of conformity do not expire on that date.
 
The interpretative document also states that certificates of conformity for medical devices placed on the market before March 21 and delivered in accordance with the current version of Directive 93/42/EC shall, in principle, remain valid until their expiration date or a renewal (in case of a change in the quality system or the design). A certificate of conformity has a maximum validity of five years. However, when a product falls within a new class of devices (e.g., from Class IIa to Class III or from Class IIa to Class IIb), the document provides no clear or direct answer regarding whether the manufacturer needs to obtain a new certificate of conformity to continue marketing its product in the EU after March 21.
 
The document acknowledges that manufacturers may have an interest in anticipating compliance with the new legislation. This could be the case, for example, when a manufacturer brings a new device type on the market for which the new requirements have been followed from the beginning.
 
However, the document also advises an approach “where a device falls in a different class requiring another conformity assessment procedure, or where the adaptation to the new requirements introduced by Directive 2007/47/EC requires changes to the approved design of a medical device or to the approved quality system of the manufacturer, which are subject to prior assessment by the responsible notified body.” This statement could be interpreted as advising that after March 21, when the quality system or the product ranges are subject to substantial change as a consequence of the enforcement of Directive 2007/47/EC, related certificates of conformity must be revised. There would appear to be nothing in the communication to permit a conclusion to the contrary.
 
New Directive Requirements

Although not intended to be exhaustive, the main changes to the existing framework of Directive 2007/47/EC are as follows:

? Technical documentation related to all medical devices must include a clinical evaluation document containing all the clinical data to support the declaration of conformity. This document must be actively updated and must incorporate relevant postmarketing surveillance data.

? Clinical investigation is required for all implantable and Class III devices unless reliance on existing clinical data is duly justified.

? Clinical investigations must be conducted in relation to surgically invasive devices that come in direct contact with the central nervous system (reclassified from Class IIa to Class III). 

? The definition of central circulatory system has been extended and now includes the vessel aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcation aortae).
 
? Clinical investigation will be required when an initial clinical evaluation concludes that the available clinical data does not allow for the full evaluation of the clinical effectiveness and safety of the medical device.
 
? Medical devices that are specifically used for disinfecting invasive devices will be classified as Class IIb (instead of Class IIa).
 
? The definition of continuous use will be expanded to include situations in which a medical device, upon discontinuation or removal, is replaced immediately by the same or with an identical medical device.
 
? Software, whether stand alone or incorporated into a medical device, will be classified as a medical device. With the implementation of the revised Directive 2007/47/EC, software becomes a new category of medical devices independent of other devices with which it may function.
 
? Medical devices will be classified by their primary mode of action and not their intended use.
 
? For borderline products that are medical devices and personal protective equipment, both the requirements of the MDD and the relevant part of Annex II to the Personal Protective Equipment Directive 89/686/EEC must be met. Manufacturers of products that are classified as both machinery and as medical devices must also comply with the requirements of Annex I to the Machinery Directive 98/37/EC and the MDD.
 
? Member states may require information on Class IIa devices.
 
? Specific requirements are introduced concerning the safety, labeling, and information of high-risk medical devices such as devices containing phthalates.
 
Conclusion

The publication of the interpretative document provided clarification concerning certain elements of Directive 2007/47/EC. However, it did not dispel all doubts concerning implications of the MDD in the circumstances discussed in this article. Therefore, it is advisable that manufacturers seek the expertise of a notified body concerning the continued validity of an existing certificate of conformity.

References

1. Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 Amending Council Directive 90/385/EEC on the Approximation of the Laws of the Member States Relating to Active Implantable Medical Devices, Council Directive 93/42/EEC Concerning Medical Devices and Directive 98/8/EC Concerning the Placing of Biocidal Products on the Market, Official Journal (OJ) of the European Union, L 247,21 (September 21, 2007).

2. Council Directive 93/42/EEC of 14 June 1993 Concerning Medical Devices, OJ, L 169,1 (July 12, 1993).

3. European Commission, “Interpretative Document of the Commission’s Services, Implementation of Directive 2007/47/EC Amending Directives 90/385/EEC, 93/42/EEC, and 98/8/EC,” (Brussels, June 5, 2009); available from Internet: http://ec.europa.eu/enterprise/sectors/medical-devices/files/guide-stds-directives/transitionalperiod_2007-47-ec_guidance_final_en.pdf.

4. Directive 93/42/EEC, Annex II, Points 3.4 and 4.4; Annex III, Point 6; Annex V, Point 3.4; or Annex VI, Point 3.4.

5. Directive 90/385/EEC, Annex 2, Point 3.4 and 4.4; Annex 3, Point 6; and Annex 5, Point 3.4.

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