Similar to the MDD (93/42/EEC), Article 2 (Placing on Market and Putting into Service) of the IVDD (98/79/EC) establishes the salient requirements with which in-vitro diagnostic devices must comply in order to gain entry to the European Union (EU).
However, under the IVDD, Article 2 has been expanded to include an obligation clause specific to Member States and their responsibility to ensure the safety and quality of in-vitro diagnostic medical devices, including devices being made available for performance evaluation. In writing this Article, Dr. D briefly thought about performing a cut-and-paste of the article the doctor penned on complying with Article 2 of the MDD, but what fun would that be? Besides, I would never want the readers of DG to accuse the good doctor of being a languid (look-it-up) writer. Dr. D’s expectation would be for the readers to revisit my blog and read the article posted in January of this year.
The IVDD – 98/79/EC
Article 2 – Placing on Market and Putting into Service
Member States shall take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. This Article applies also to devices made available for performance evaluation.
What IVD manufacturers need to know
A phrase that Dr. D likes invoke from time to time is, “There is no such thing as partial compliance with a regulatory requirement mandated by law, there is only compliance!” That being said, there is no such thing as minimum compliance. There is no such thing as maximum compliance. Why? Let the doctor repeat, “There is only compliance!”
Hoping that the readers have grasped the point just made, the fundamental purpose of Article 2 is to establish the need for in-vitro diagnostic devices to comply with all of the requirements delineated within the Directive. Simply stated, manufacturers of IVD devices cannot pick and choose the Articles and Annexes they wish to comply with. In fact, the employment of Article 9 and Annex II (List A and List B) will drive the conformity requirements needed for device manufacturers wishing to gain entry into the EU, for their devices.
One point that Dr. D needs to make is in regards to Annex II and the pending reclassification of devices listed under List A and List B. As stated in the doctor’s Introduction to the IVDD
article, this will eventually change and the changes will be substantial. Trust me, even the notified bodies are concerned with the proposed changes.
Similar to the MDD, IVD medical device manufacturers need to have an experienced notified body; and preferably one with substantial IVDD experience in dealing with:
(a) Technical documentation (technical files and design dossiers);
(b) Meeting essential requirements;
(c) Preparing signed Declarations of Conformity (DoC);
(d) Device applications;
(e) Data retention;
(f) Establishing an approved quality management system (QMS);
(g) Notified body audits;
(h) Vigilance reporting (post-market surveillance);
(i) The CE marking of conformity;
(j) Establishing a European Authorized Representative; and
(k) All of the other regulatory requirements do not change.
Remember, the expense associated establishing a QMS and activities performed by the notified bodies are considered the basic price of admission into the European IVD device market.
Finally, even the Competent Authorities from each of the Member States have proverbial “skin in the game” under Article 2. As stated earlier, Member States have a clear responsible thrust upon their shoulders under this Directive. Member States, which means the Competent Authorities, shall “monitor the security and quality of these devices (a.k.a. IVD medical devices).”
What IVD manufacturers need to do
If the manufacturer is already entering devices into the EU under the MDD, then the additional challenges posed by the IVDD should be fairly easy to navigate. In fact, the additions to Article 2 under the IVDD only impact Member States and ultimately, the Competent Authorities, with added responsibilities. For IVD medical device manufacturers, they are expected to comply with all aspects of the Directive, as delineated under Article 2. Remember, not minimum compliance, not maximum compliance, “just compliance.”
There are three takeaways for this edition of DG. (1) Similar to the MDD, Article 2 establishes the requirement that IVD medical device manufacturers must comply with the Directive, the whole Directive and nothing but the Directive. (2) There is no such thing as minimum compliance, or maximum compliance, just compliance. (3) Member States have the responsibility for the security and quality of IVD medical devices.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 3 (Essential Requirements) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – 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.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in Medical Device Summit.
- Directive 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
- EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).
The device industry is far from being utopic, so manufacturers need to be ready to quickly respond to and act with integrity when the Competent Authorities come knocking on the door with concerns about device safety and efficacy.
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