During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive (a.k.a., the IVDD) while extracting salient elements in the hope of providing Devine Guidance for the readers. I am happy to announce, this journey has come to an end.

For readers that have joined the doctor for all or even part of this journey through exploring the IVDD. I thank you. I know several readers have written Dr. D and asked if the doctor will be following up this series with another book? The answer is yes, so please stay-tuned; Devine Guidance for Complying with the IVDD will be available in the fall.

That being said, the doctor would like to provide some insight and wisdom, while attempting to summarize the IVDD series. Let me start by saying the doctor has occasionally experienced some level of a hypnagogic (look-it-up) state as he fell off into REM sleep after an exhaustive day of typing. Unfortunately, the resulting dreams were usually compliance-based nightmares, which Dr. D attempted in earnest, though his ranting and writing, to save my readers from experiencing the same horrific dreams. The key to avoiding compliance nightmares is living and believing in a simple mantra, “Just Comply, Baby!”

Dr. D really struggled on how to wrap-up and place a pretty bow on this series about understanding and complying with the IVDD. Since it really did not make sense for the doctor to revisit all of the Articles and Annexes as part of a large summary, Dr. D decided to provide some pearls of wisdom that hopefully will keep the readers and their organization out of regulatory Hades.     

1. Never take shortcuts in regards to the Quality Management System (QMS). Once the QMS has been approved by your notified body, ensure that it is monitored, reviewed, revised, and maintained, in a constant of compliance (hint – it all starts with EN ISO 13485:2003).
2. Use QMS tools such as internal audits, management reviews, and CAPA to keep the QMS in compliance.
3. Consider the selection of a qualified notified body a mission critical activity. 
4. Treat the notified body relationship like a marriage; hopefully a good marriage, because the notified body is the portal into the European device market.
5. Always design, develop, and manufacture a quality medical device. If a medical device cannot be deemed safe and effective in its intended use; or in the case of an IVDD, capable of providing accurate and repeatable results, well – what is the point?
6. Make sure all medical devices and the processes employed to build them are properly verified and/or validated.
7. Compiling technical files and design dossiers for review and approval by the notified bodies is only half of the regulatory challenge. Ensure this technical documentation is properly maintained for the life of the product.
8. Place the CE marking of conformity onto the packaging of all approved medical devices shipped into the EU. 
9. Never wrongly affix a CE Mark to unapproved product.
10. Maintain an effective post-market surveillance system to address customer complaints and vigilance reports. If a medical device is hurting the user or the patient, do not hesitate to pull it from the market.
11. All medical devices require a signed Declaration of Conformity (DoC) as part of the application process. Ensure the Chief Jailable Officer (CJO) signs the DoC.
12. When the Competent Authorities ask you jump, ask: “How high?” 
13. Changes to the IVDD are coming. Make sure your organization is proactive and quickly identifies and incorporates these changes.
14. When in doubt, ask your notified body. You pay them for their support so make them earn their paychecks.

In closing out this series on the IVDD, there is only one takeaway; “Just Comply Baby!” That being said, Dr. D would first like to thank the staff of the Medical Device Summit for their support (Rick, Sangita, Tom, and Marc).

Secondly, Dr. D would like to thank BSI-America for sponsoring the DG series on the IVDD.

Finally, and most importantly, the doctor would like to personally thank all of the readers of DG. Without you, there would be no Devine Guidance, at least from a medical device perspective. Please stay-tuned for the next series on one of the largest device markets outside of the United States – it’s a surprise! Cheers from Dr. D and best wishes for continued professional success.

 

1. Devine, C. (2012). Devine Guidance series on complying with the IVDD. Published in The Medical Device Summit. http://medicaldevicesummit.com
2. 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
3. EN ISO 13485:2003. (2004, February). Medical devices – quality management systems – requirements for regulatory purposes (ISO 13485:2003).