Devine Guidance

IVDD – An Introduction

Dr. D would like to begin this new series of DG by providing a definition for the term “in vitro.” According to Merriam-Webster’s on-line dictionary, the Latin translation for “in vitro” is “in glass.” Now the doctor understands that not many folks are walking around speaking Latin anymore; so the English translation is “outside the living body and in an artificial environment.” Now for the Latin translation, the only thing that Dr. D prefers in vitro is good bourbon. However, if Dr. D walked up to the bar and asks for; “Jack on the rocks – in vitro,” I am sure the bartender would quickly show the good doctor the door.

Getting back to the IVDD, the readers are going to find a significant amount of similarities between the IVDD and the MDD. The IVDD is equally verbose and is broken down into Articles and Annexes, just like the MDD. In fact, many of the Articles and Annexes share the same titles as the MDD. So why bother with a stand-alone Directive Dr. D? It seems the regulatory folks in the EU could have easily expanded on the virtues of the MDD and save themselves the time and effort of creating another Directive.

That being said folks, is not the doctor’s call, besides another Directive gives Dr. D the chance to continue writing so the readers can enjoy his colorful approach to analyzing the IVDD and providing some useful guidance.

The IVDD was ratified by the European Parliament on 28 October 1998. There are 24 Articles and imbedded in the body of the IVDD. The Articles are:

1. Article 1 – Scope, definitions
2. Article 2 – Placing on the market and putting into service;
3. Article 3 – Essential  requirements;
4. Article 4 – Free movement;
5. Article 5 – Reference to standards;
6. Article 6 – Committee on Standards and Technical Regulations;
7. Article 7 – “No title” A continuation of Article 6;
8. Article 8 – Safeguard clause;
9. Article 9 – Conformity assessment procedures;
10. Article 10 – Registration of manufacturers and devices;
11. Article 11 – Vigilance procedures;
12. Article 12 – European databank;
13. Article 13 – “No title” Protection of public health and safety clause;
14. Article 14 – Amendments to Annex II, and derogation clause;
15. Article 15 – Notified bodies;
16. Article 16 – CE marking;
17. Article 17 – Wrongly affixed CE marking;
18. Article 18 – Decisions in respect of refusal or restriction;
19. Article 19 – Confidentiality;
20. Article 20 – Cooperation between Member States;
21. Article 21 – Amendment of directives;
22. Article 22 – Implementation, transitional provisions;
23. Article 23 – “No title” Publication into the Official Journal clause; and
24. Article 24 – “No title” Directive addressed to Member States clause.

The Annexes associated with the IVDD are:

1. Annex I – Essential Requirements;
2. Annex II – List of Devices Referred to in Article 9(2) and (3) – Lists A & B;
3. Annex III – EC Declaration of Conformity;
4. Annex IV – EC Declaration of Conformity (Full Quality Assurance System);
5. Annex V – EC Type-Examination;
6. Annex VI – EC Verification;
7. Annex VII – EC Declaration of Conformity (Production Quality Assurance);
8. Annex VIII – Statement and Procedures Concerning Devices for Performance Evaluation;
9. Annex IX – Criteria for the Designation of Notified Bodies; and
10. Annex X – CE Marking of Conformity.

As most device industry professionals realize, the introduction of new regulations or changes to regulations always creates an elevated level of angst. Guess what? The IVDD is no exception. The reason Dr. D is saying this is because changes to the IVDD are on the horizon. In June of 2010, the European Commission made the decision to ask for public comments in regards to proposed revisions to the Directive. The Commission was very specific when drafting a series of questions applicable to current sections in the Directive and potential additions to the Directive. Early in 2011, the Commission published the results. A few of the key areas where opportunities for change and improvement were noted:

1. The Classification System, specifically clarity surrounding List A and List B devices depicted under Annex II (expanded risk-based classification to be considered);
2. Revision and/or potential deletion of Annex VI – EC Verification; 
3. Clarification of device testing modalities;
4. Clinical requirements; and
5. The addition of an option to obtain a Conditional CE Marking of Conformity.  

In short, it is inevitable that revisions to the IVDD will happen. Some of the notified bodies the doctor has spoken with expect these changes to become effective in 2015. A final draft should be available next year. 

Now granted, change is inevitable so what else do the manufacturers of IVD medical devices need to know? 

1. For starters, the Quality Management System (QMS) should still be premised on ISO 13485:2003. 
2. The IVDD is the law of the land for the 27-Member States comprising the EU. 
3. The path for conformity and the obtainment of the CE marking of conformity is defined within the IVDD.
4. IVD medical devices need to conform to their essential requirements.
5. Technical documentation, including design dossiers, is still required as part of the approval process through the notified bodies.
6. Devices categorized under List A (high-risk) requires a mandatory examination of the technical documentation by a notified body (prepare the dossier).
7. The establishment of a European Authorized Representative is still a requirement.
8. IVD devices still require a CE Mark reflecting the registration number of the manufacturer’s notified body.
9. The establishing of a post-market surveillance program remains a salient requirement.
10. The Chief Jailable Officer (CJO) still needs to sign the Declarations of Conformity.

The late Al Davis, National Football League Hall of Fame Member and the long-time owner of the Oakland Raiders always used to say, “Just win-baby-win!” Dr. D would like to borrow his tag line and say, “Just comply-baby-comply!” Regardless of the perceived idiosyncrasies associated with 98/79/EC, compliance to this Directive is mandated by law within the EU. The similarities to 93/42/EEC should make compliance to the IVDD a relatively simple task for device manufacturers with experience introducing medical devices into the EU, under the MDD. However, there are some subtle differences that can make attempts at complying with the IVDD a frustrating experience. For example, correctly identifying the appropriate classification of a device in accordance with List A versus List B (Annex II) appears to pose a significant challenge for IVD device manufacturers. Dr. D always recommends holding court with the notified body to ensure the correct device classification is selected in accordance with Annex II. 

Similar to the MDD, IVD device manufacturers are required to comply with basic requirements delineated throughout the directive. For example IVD device manufacturers: