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What is the Status of Directive 2007/47/EC?

Evangeline Loh

Transitions aren’t always easy. For example, I recall price placards at a shop in Portugal during a trip in December 2001. The shopkeeper generously had thought to educate consumers by quoting the Portuguese escudo and European Union’s euro, in preparation of the euro’s introduction as the currency on January 1, 2002. The shopkeeper wanted his customers to be accustomed to the euro and understand the correlation between the two. A transition period existed for 59 days during which time both the escudo and euro were accepted as legal tender. That period of time was necessary for consumers to get used to the new currency.

But how does this relate to medical devices? Medical device companies often need a transition period to prepare for and adapt to new or changed regulations. In particular, manufacturers often inquire about the transitional provisions of Directive 2007/47/EC. They are interested in understanding when they must be compliant with the Medical Devices Directive MDD 93/42/EEC, as amended by Directive 2007/47/EC.

To see how prepared you are, let’s take a short quiz. Please select what you think is the best answer.

When must manufacturers comply with Directive 2007/47/EC?

a. As of Dec. 21, 2008

b. After the five-year transition period

c. Whenever they want after Dec. 21, 2008

d. Whenever they want after March 21, 2010

e. By March 21, 2010

A Little History

When the Medical Devices Directive (MDD) was published in mid-June 1993, Article 22 provided for a transition period. The deadline for member states’ transposition of the MDD 93/42/EEC into their national laws/ regulations was July 1994. Application of the provisions occurred from Jan. 1, 1995, onward, and manufacturers could comply with the MDD or member-state national regulations. There was a five-year transition period. The drop-dead date was recognized as June 1998. It is understandable that CE marking medical devices was a novel concept at the time, and thus medical device manufacturers, competent authorities, notified bodies and users needed time to adjust.

Transitional Period forDirective 2007/47/EC?

It is understood that member states had until Dec. 21, 2008, to transpose the modification into their national laws. Have all member states met this date? No. And, member states need to apply the measures beginning March 21, 2010. What is the transition period?

Think you got the answer correct to the quiz above? The best response to the question is not response C, though it is partially correct. Response E is most accurate. The European Commission expressed its interpretation on the implementation of Directive 2007/47/EC in a document issued in June of this year (ENTRA/F3/PBE/D(2009) 19003). After March 21, 2010, medical devices placed on the market or put into service, must conform to the (new) requirements of the revised directives. This is applicable to each individual product. The terms “placing on the market” and “putting into service” are defined in Article 1 of the MDD 93/42/EEC.

European CommissionInterpretation

Directive 2007/47/EC does not discuss a period of transition. Thus, the European Commission document seeks “to guide a uniform practice throughout the EU.”  The document discusses five key topics:

• Compliance of medical devices with the new requirements

• Evaluation by notified bodies according to the new requirements

• Certificates issued prior to the application of Directive 2007/47/EC

• Consultation of authorities responsible for pharmaceuticals

• Overlap with the machinery directive

Directive 2007/47/EC Timelines

By March 21, 2010, manufacturers’ devices must be compliant with the modified Directive (Directive 2007/47/EC). Compliance before March 2010 is voluntary. Products already lawfully on the market or put into service prior to March 2010 can continue to be marketed.

However, if a manufacturer’s devices are compliant before the March deadline, the Declaration of Conformity (DoC) for the device should document the compliance with the directive and include the text: “as amended by Directive 2007/ 47/EC.” And if a notified body is involved in issuing the CE marking for the device, it must have verified compliance with Directive 2007/ 47/EC, before the DoC reflects compliance with Directive 2007/ 47/EC. 

The notified body’s CE marking certificate never would reflect inclusion of Directive 2007/47/EC—the notified body’s audit report or design dossier examination report would indicate that conformity assessment was performed to include consideration of Directive 2007/47/EC.

Directive 2007/47/ECIs an Amending Directive

Said another way, on March 21, 2010, Directive 2007/47/EC is integral to and considered part of MDD 93/42/EEC. Modifications made by Directive 2007/47/EC are denoted by footnote M5 in the consolidated version of the Directive. DoCs issued after March 21, 2010, are presumed to be compliant to the MDD and AIMDD as amended—DoCs after that date would not reference Directive 2007/47/EC. And any notified body assessments (renewal or delivery) that occur after the March deadline must consider the (new) requirements of the revised directives. Medical devices whose classification was modified as a result of Directive 2007/47/EC (changes to Annex IX, Classification Criteria) must have obtained a new certification if it is placed on the market or put into service on March 22, 2010.

The Days of Unlimited CEMarking Certificates Are Over

By the March 2010 deadline, notified bodies should no longer issue unlimited CE marking certificates (MDD 93/42/EEC Annex V and Annex VI, AIMDD 90/385/EEC Annex 2 and Annex 5): These are to be limited to a maximum of five years. Also, prior to the deadline, existing unlimited certificates need to be reissued with a limited validity that has considered Directive 2007/47/EC.

Conclusion: March 21, 2010

If your conformity assessment involved a notified body, it is strongly recommended that the status of the current CE marking certificates and the provisions of Directive 2007/47/EC be discussed with the notified body. The most important takeaway from this column is that manufacturer’s medical devices must be compliant by March 21, 2010, to the MDD, as revised by Directive 2007/47/EC.

Evangeline Loh, Ph.D., R.A.C., is vice president of regulatory affairs for Emergo Group, an international consulting firm providing regulatory, quality assurance and distribution consulting services. Emergo has offices in the United States, Europe, Japan, China, Canada, Mexico and Australia. Evangeline can be reached at [email protected].