In this edition of Devine Guidance (DG), the doctor will provide guidance for the final two Articles associated with Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD). Article 22 of the MDD delineates the requirements for “Implementation, Transitional Provisions.” Simply put, Article 22 mandates that Member States are required to comply with the MDD no later than 01 July 1994. Now Dr. D believes it is a pretty safe bet to assume that 17 years after the fact, Member States are complying with this Directive.
Article 23 of the MDD, contains no formal title. That being said, Dr. D refers to this Article as the “Formal Address Clause.” As for Article 23, it contains one eight-word sentence; “This Directive is addressed to the Member States.” Because Article 23 is so eloquently simple, the doctor will provide just one piece of guidance for this Article. It is not addressed to device manufacturers, it is addressed to Member States; and no the doctor is not trying to be a wise guy (well, maybe just a little). All kidding aside, just because Article 23 is addressed to Member States; it does not mean device manufacturers do not have to comply with the Directive. Remember, the MDD is not a piece of supposititious (look-it-up) legislation but the law within the European Union (EU) and compliance is mandatory.
The MDD – 93/42/EEC
Article 22 – Implementation, Transitional Provisions
- Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive not later than 1 July 1994. They shall immediately inform the Commission thereof. The Standing Committee referred to in Article 7 may assume its tasks from the date of notification (1) of this Directive. The Member States may take the measures referred to in Article 16 on notification of this Directive. When Member States adopt these provisions, these shall contain a reference to this Directive or shall be accompanied by such a reference at the time of their official publication. The procedure for such reference shall be adopted by Member States. Member States shall apply these provisions with effect from 1 January 1995.
- Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field covered by this Directive.
- Member States shall take the necessary action to ensure that the notified bodies which are responsible pursuant to Article 11 (1) to (5) for conformity assessment take account of any relevant information regarding the characteristics and performance of such devices, including in particular the results of any relevant tests and verification already carried out under preexisting national law, regulations or administrative provisions in respect of such devices.
- Member States shall accept: —devices which conform to the rules in force in their territory on 31 December 1994 being placed on the market during a period of five years following the adoption of this Directive, and —the aforementioned devices being put into service until 30 June 2001 at the latest. In the case of devices which have been subjected to EEC pattern approval in accordance with Directive 76/764/EEC, Member States shall accept their being placed on the market and put into service during the period up to 30 June 2004.
Article 23 – “Note: There is no title”
This Directive is addressed to the Member States.
What you need to know
Article 22 is broken down into four components directed at the Member States. The first component prescribes the need for Member States to “adopt and publish the laws, regulations, and administrative provisions” before the drop-dead date of 01 July 1994. Simply stated, compliance to the Directive is mandatory by the July date. The second component of Article 22 is a requirement for Member States to communicate the provisions made in regard to national law, in support of this Directive, back to the Commission.
The third and fourth components of Article 22, at the time of the initial release of the Directive, did have the potential to influence medical device manufacturers and the devices they entered into commerce within the EU. Specifically, the third component of Article 22 directed Member States to ensure notified bodies re-evaluated devices approved under national standards and the relevancy of testing and verification activities previously performed. The fourth and final component of Article 22 directed Member States to grant approval for devices that conformed to their country-specific rules in place on 31 December 1994. The Directive delineated a five-year period, “following the adoption of this Directive.” So Dr. D what does all of this really mean? In short, Article 22 really has no impact on device manufacturers today. The dates critical to device manufacturers have long passed; and the first two components of Article 22 are directed at the Member States.
Article 23 is addressed to Member States. While device manufacturers need to know that there are 23 Articles associated with the Directive, however, Article 23 does not affect them. In fact, since Article 23 is so simple, you may want to impress your friends by being able to recite an entire Article from memory. Then again, what would be the point?
What you need to do
I love it when the good doctor has the opportunity to say; “Device Manufacturers have nothing to do or worry about in regards to these Articles.” Once again folks, Dr. D will climb to the top of his soapbox and commence with the broken-record speak. Compliance to the Directive is mandatory; however, not all of the Articles apply directly to Device Manufacturers. That being said, all of the provisions depicted in Article 22 that may have influenced a device manufacturer’s product being in the EU have long-since expired. The other requirements mandated by Article 22 are Member State centric. As for the very complex and succinct Article 23, it is directed to Member States, period.
For this edition of DG, the doctor will leave just one piece of guidance, “forgetta-bout-it” (a quote made famous by James Gandolfini – a.k.a., Tony Soprano). Seriously, device manufacturers need to know that there are 23 Articles; however, in regards to Articles 22 and 23, they have zero influence on device manufacturers so please, just “forgetta-bout-it.”
Until the next installment of DG, when Dr. D will begin providing guidance for complying with Annexes of Council Directive 93/42/EEC, the MDD – cheers from Dr. D and best wishes for continued professional success.
- Council Directive 93/42/EEC. (1993, June). Council Directive 93/42/EEC concerning medical devices. Retrieved December 21, 2010, from http://eur-lex.europa.eu
- Devine, C. (2009, July). Exploring the effectiveness of defensive-receiving inspection for medical device manufacturers: a mixed method study. Published doctoral dissertation. Northcentral University. Prescott Valley, AZ.