Articles 6 and 7, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineate the requirements for “Committee on Standards and Technical Regulations.”

I would like to begin this edition of Devine Guidance (DG) talking a little bit about the importance of the Medical Device Directive (MDD). I attended the MD&M show in Anaheim on February 8 and 9, and was blessed with the opportunity to catch up with some old friends. That being said, a dear friend of mine (yes- the doctor does have a few friends) asked me, “How can Dr. D continue to write about such boring subjects such as regulations influencing the medical device industry?” The doctor’s answer to the question was quite elementary: “If device manufacturers fail to embrace and understand regulations, how can they expect to be successful in this industry?” My final answer (not for a million dollars) to the question was, “device manufacturers will not be successful if they fail to embrace regulations, and that is why I continue to write. At the end of the day, it is my goal to teach, enlighten, and occasionally entertain the readers of DG using common sense and some levity.”

That being said, one thing to remember when reading the MDD is that the document not only affects device manufacturers, it establishes the ground rules for the Member States in Europe, in regards to regulating medical devices. Another concept to remember is that decisions in the European Union (EU) are, for the most part, made by a commission and supported by committees. This can be a daunting task when you consider a few basic facts: one, there are now 27 Member States, and two, each Member State has a say in the regulatory process concerning medical devices. That is the premise for this week’s brief discussion on Articles 6 and 7. Please keep in mind, Dr. D would never offer brummagem (look-it up) advice when writing about quality and regulatory issues facing device manufacturers; advice on picking racehorses, maybe so.

The MDD – 93/42/EEC
Article 6 – Committee on Standards and Technical Regulations

1. The Commission shall be assisted by the Committee setup by Article 5 of Directive, hereinafter referred to as ‘the Committee’.
2. Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC (2) shall apply, having regard to the provisions of Article 8 thereof.
3. The Committee shall adopt its rules of procedure.

Article 7

1. The Commission shall be assisted by the Committee setup by Article 6(2) of Directive 90/385/EEC, hereinafter referred to as ‘the Committee’.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. Where reference is made to this paragraph, Article 5a (1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
4. Where reference is made to this paragraph, Article 5a (1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

What you need to know
Yes, the MDD can really make your head spin with all of the pointers to Articles and paragraphs inserted into multiple locations throughout the Directive. You can call it EU legalese, you can say that the document reflects too many cooks having their hands into the proverbial pot; however, Dr. D calls it job security as the Directive is law in the EU just like the Quality System Regulation (QSR) is law in the United States. Deal with it!

So what should device manufacturers really understand about Articles 6 ad 7 of the MDD. Dr. D’s simple answer is that device manufactures only need to know Articles 6 and 7 exist. These articles, the doctor’s opinion, have no bearing on the day-to-day operations of device manufacturers. These Articles influence the commission and the establishment of the committee, and the adoption of rules by the committee once established. Is this an over simplification? In Dr. D’s humble opinion, no.

What you need to do
Nothing! No the doctor is not “bonkers.” From a device manufacturer’s standpoint, no action is required. Yes, the expectation is to continue to recognize and preferably employ harmonized standards whenever possible. Articles 6 and 7, influence standard oversight within the EU, but do not directly influence device manufacturers. Besides, as a device manufacturer, you do not make the rules, regardless of venue. Why? Because the regulators own the medical device sand box, and that gives them the right to make their own rules. Yes, device manufacturers can influence the rules through a number of venues; however, device manufacturers do not make them.

Takeaways
For this edition of DG, the takeaway is simple, read and understand Articles 6 and 7; however, do not lose sleep worrying over their impact on device manufacturers. Why? Because Articles 6 and 7 pertain to the Commission, the Committee and the establishment of rules for the oversight of standards, period.

Until the next installment of DG, when Dr. D will provide guidance for complying with Article 8 (Safeguard Clause) of Council Directive 93/42/EEC, the MDD – cheers from Dr. D. and best wishes for continued professional success.

References:

1. 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

2. 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.