In fact, Articles 6 and 7, which went through a rescript in 2003, are so confusing with all of the pointers to other Directives, Decisions, and Articles; the doctor was almost driven to lachrymose (look-it-up) with tears of pain forming in the corner of my eyes. Well, not exactly, as Dr. D was typing this guidance, one of my dogs ran into a wall while attempting to chase a cat down the hallway. In reality, the doctor was actually laughing hysterically. 

 

I know back to the guidance Dr. D. Articles 6 and 7 really are somewhat difficult to comprehend versus their original format when the IVDD was first released. Under Article 6, the Commission receives assistance from the Committee established under Article 5 of Directive 98/34/EC. However, under Article 7 of the IVDD the Commission is assisted by the Committee setup by Article 6 of Directive 90/385/EEC (the AIMD). What the heck Dr. D, these revisions are down-right confusing. Can’t the regulatory gods in the EU leave well enough alone? 

 

Regardless, the Committee’s primary task is to review and provide opinions in regards to standards and technical regulations; henceforth, the title of Article 6. Just to drive home a point Dr. D would like to repeat that, Articles 6 and 7 were part of a rescript of the Directive that occurred on September 2003 under Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003; and Regulation (EC) No 596/2009 of the European Parliament and of the Council of 18 June 2009. Dr. D has taken the liberty of presenting the old and the new for clarification purposes. 

 

Regardless, the purpose of the revised Articles 6 and 7 are inherently the same, with the addition of regulatory double-speak and EU legalese sprinkled into the mix. Dr. D’s personal opinion is that Articles 6 and 7 were fine as originally scripted, but hey, half the fun of the device industry lies in deciphering crazy changes.

 

1. The Commission shall be assisted by the Committee set up by Article 5 of Directive 98/34/EC (hereinafter referred to as ‘the Committee’).
2. Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC (1) shall apply, having regard to the provisions of Article 8 thereof.
3. The Committee shall adopt its rules of procedure.

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

1. The Commission shall be assisted by the committee set up by Article 5 of Directive 98/34/EC.

2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter, if necessary by taking a vote.

The opinion shall be recorded in the minutes; in addition, each Member State shall have the right to ask to have its position recorded in the minutes.

The Commission shall take the utmost account of the opinion delivered by the committee. It shall inform the committee of the manner in which its opinion has been taken into account.

 

1. The Commission shall be assisted by the committee set up by Article 6(2) of Directive 90/385/EEC.
2. The representative of the Commission shall submit to the committee a draft of the measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the majority laid down in Article 148(2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the committee shall be weighted in the manner set out in that Article. The chairman shall not vote. The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the committee. If the measures envisaged are not in accordance with the opinion of the committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority. If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.
3. The committee referred to in paragraph 1 may examine any question connected with the implementation of this Directive.

Thank God, Articles 6 and 7 can be categorized as “nice-to-know” pieces of information as they really have no direct effect or bearing on the day-to-day activities pursued by IVD medical device manufacturers. The Committee is empowered to review and provide opinions in regards to regulations and standards. If necessary, this does become somewhat of a democratic process as a vote can be held in support of the overall process of delivering a binding opinion. 

 

Typically, the entire review and opinion process commences when a duly appointed representative of the Commission submits a draft or proposal of measures to be taken to the Committee. Work being pursued by the Committee can also be prioritized premised on the sense of urgency invoked by the Commission. Since the EU is a collection of 27 Member States, each State retains the legal right under the Directive to have their opinion/position clearly stated for the record and recorded in the minutes taken. In fact, all opinions rendered are to be recorded in the minutes. 

 

Finally, the Commission must seriously consider all opinions drafted by the Committee. The Commission cannot arbitrarily ignore the opinion of the Committee without written justification supporting their decision. Although the current revision to the standard no longer eloquently states the roles of the Committee and the Commission, the salient purpose of Articles 6 and 7 remain intact.

Folks, there is no need to lose sleep over worrying about the potential impact of Articles 6 and 7 of the IVDD to your business. As the doctor stated earlier, these Articles all about the Commission, the Committee, and the Member States. IVD medical device manufacturers should have a basic understanding of the process; however, the only real influence on your business is when changes to standards and technical regulations are actually published.

 

In closing this week’s guidance, IVD device manufacturers should always be aware of obscure and not so obscure changes made to the IVDD and Directives as a whole, especially with more changes to the IVDD being planned. As a regulatory and quality professionally, changes that appear irrational continue to drive Dr. D bonkers. 

 

That being said, I am sure the regulatory gods in the EU will be angry at the doctor for providing a less than flattering critique of their changes to Articles 6 and 7, which were previously perceived as well-written and comprehendible. Please learn to leave well-enough alone, as change is not always necessarily good. 

 

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 8 (Safeguard Clause) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD, cheers from Dr. D and best wishes for continued professional success.

References: 

1. Council Directive 90/385/EEC. (1990, June). Council Directive 90/385/EEC on the approximation of the laws of Member States relating to active implantable medical devices. Retrieved November 15, 2011, from http://eur-lex.eurpoa.eu
2. 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
3. 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.
4. Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The Medical Device Summit. http://medicaldevicesummit.com
5. Directive 98/34/EC. (1998, June). Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 – laying down a procedure for the provision in the  field of technical standards and regulations and of rules on information society services. Retrieved November 15, 2011, from http://eur-lex.europa.euDirective 98/79/EC. (1998, October). Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Retrieved September 12, 2011, from http://eur-lex.europa.eu