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European Medical Device Directive 93/42/EEC: Major Changes Ahead

Rene Van De Zande

Rene van de Zande is president and CEO of Emergo Group, a medical device quality assurance and regulatory  affairs consulting firm with offices in the United States, Europe and Australia. He can be reached at [email protected].

Those of you who export to Europe will certainly be interested in learning about some important changes that are being proposed for the Medical Device Directive 93/42/EEC (aka the MDD) that govern medical devices, plus some changes that will also impact the In Vitro Diagnostic Devices Directive and Active Implantable Medical Device Directive.

Recently, the European Commission released the latest and final recommendations for changes to the MDD. While the reforms fall short of what some had hoped for, there are significant changes nonetheless and regardless of what type of device you manufacture, you should be aware of them.

Summary of Changes

Following are some of the more important changes that will take place once the recommendations are adopted. The Commission Draft Proposal, released December 22, 2005, recommends the following:

Active implantables—The Active Implantables Medical Device Directive 90/385/EEC was adopted in 1990, before the MDD and IVDD. Important updates have been made that make it more coherent with the MDD 93/42/EEC, including references to the Authorized Representative, European databank, health protection and the application of Directive 2000/70/EC concerning devices incorporating stable derivatives of human blood of plasma.  

Authorized Representative (AR)—Appointment of an AR for all classes of devices is now explicitly noted. The AR gets an explicit mandate to act, and be contacted, in lieu of the manufacturer in terms of meeting the obligations by the Directives.

Borderline Products—Whether a product is a drug or device will be determined by the Primary Mode of Action rather than by the Intended Use! If you manufacture a product that could be classified as a drug or device, be sure to read the official EU Guidance document MEDDEV 2.1/3 Rev 2 from July 2001.

Central circulatory system—This now includes the vessels aortic arch (arcus aortae) and descending aorta (aorta descendens) to the aortic bifurcation (bifurcatio aortae). Any devices that come in contact with these vessels will now be considered Class III.

Clinical data—All devices now require these data, including Class I devices. Also, this imposes more stringent requirements as to what constitutes “clinical evidence” and mandates stronger enforcement by authorities. Annex X on Clinical Evaluations has been significantly amended.

Combination devices—If a medicinal product, as defined in Article 1 of Directive 2001/83/EC, is used “in such a way that the device and medicinal product form a single integral product which is intended solely for use in the given combination and which is not reusable, that single produce shall be governed by Directive 2001/83/EEC.” Annex I of this Directive will govern safety and performance.

Conformity assessment—Class I Sterile and Measuring devices now have more flexibility to select a route to compliance, as they will be given the option to select a full quality assurance conformity assessment module. See Annex II of the MDD.

Definition of “continuous use”—This now includes situations in which a device, upon discontinuation or removal, is replaced immediately by the same or with an identical device.

e-Labeling—A provision has been made that opens the door for Instructions for Use to be delivered through electronic media instead of the “leaflet” format currently noted. This would be especially useful for companies that sell in many EU countries because it could potentially allow them to pass along the IFU on a CD or via other electronic means, eliminating the many different paper versions now required. The proposed draft does not explicitly allow this yet.

Ergonomics (“human factors”)—Both in terms of the Essential Requirements (Annex I) and in terms of labeling, the user is now considered a key factor.

EU medical devices agency—The final proposal does not call for the creation of a pan-European devices agency similar to the US FDA.

European databank—Data related to clinical investigations will now be collected for the European databank and shared among Competent Authorities. The databank will also include information on registration, Authorized Representative, certificates and vigilance data. The data must be submitted in a standardized format, yet to be determined. At this time, the European databank is not operational.

Human tissue—Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III. Many changes are included in this section, and companies that have these products should review the final draft proposal carefully.

Increased transparency—Certain non-confidential summary information on devices will now be publicly available. Manufacturers of Class IIb and Class III devices will be required to submit a summary of information and data related to the device.

In Vitro Diagnostics—IVDs are now specifically excluded from Directive 98/8/EC on Biocides, eliminating confusion as to which Directive applies.

Outsourced design and manufacturing—If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the party’s quality system. This can, of course, be achieved through audits, receiving inspections or other means.

Notified Bodies—These will be required to perform an inspection of design documentation for a representative sample of devices using industry standard statistical techniques and “commensurate” with the risk of the device.

Post market surveillance—Custom devices will now require a post-market surveillance system that is reportable to Competent Authorities.

Records retention—Records must now be maintained for inspection by the Competent Authorities for the “useful life of the product” or five years from date of manufacture, whichever is greater. The former rules indicated that you must maintain records for a period of five years but did not specify “from date of manufacture.” If you have never established a “useful life” for your product, you should do so.

Reusable surgical instruments—In earlier drafts, the Commission recommended that these products and other surgically invasive devices for transient use be moved to Class IIa. They will, however, remain Class I devices. The proposed changes had a lot of people up in arms and, in the end, the Commission realized that strengthening their classification was not commensurate with the risk posed to the public.

Software—This will now be considered an active medical device, whether integral with the device or as a stand-alone product. Software validation will also be an Essential Requirement in Annex I.

This is a very high level summary of the most common changes. They must now be adopted by the European Parliament and published in the Official Journal of the European Union. This is expected in the second or third quarter of 2006 and the new Directive will go into effect 20 days following the published date, with an anticipated 12-month transition period following publication.  

You may want to review the many other changes to the MDD not described here. To see a copy of the Final Draft Commission Proposal, visit the main EU Web site at http://europa.eu.int/comm/enterprise/ medical_devices or simply type “European medical device directive” into Google to find links to the official Europa Web site.

Rene van de Zande is president and CEO of Emergo Group, a medical device quality assurance and regulatory  affairs consulting firm with offices in the United States, Europe and Australia. He can be reached at [email protected].