Article 20 (Cooperation between Member States) of the IVDD (98/79/EC) is all about cooperation. Who knew? Under Article 20 the Competent Authorities, from each Member State, are required to cooperate with each other and share information in the pursuit of ensuring compliance with the IVDD is sustained.
Now granted, Dr. D has previously discussed EUDAMED, the European Databank on Medical Devices, as a tool to collect and share relevant information such as certificates issued by notified bodies. However, cooperation is really much more than a shared database. The expectation, in regards to Article 20, is to enforce and expand the lines of effective communication and data sharing amongst Member States.
For example, if a serious device problem has been discovered in the United Kingdom (UK), Medicines and Healthcare products Regulatory Agency (MHRA) can pick up the phone and make a call to the Irish Competent Authority, Irish Medicines Board (IMB) and ask if healthcare professionals in Ireland are having the same problem. Heck, a trip across the Irish Sea for a quick chat over a couple of pints might be in order. At any rate, extemporaneous (look-it-up) meetings between the Competent Authorities are strongly encouraged in pursuit of the spirit of cooperation between the 27-Member States.
The IVDD – 98/79/EC
Article 20 – Cooperation between Member States
Member States shall take appropriate measures to ensure that competent authorities charged with the implementation of this Directive cooperate with each other and convey to each other the information necessary to ensure application in compliance with this Directive.
What IVDD medical device manufacturers need to know
Similar to the last edition of DG when Dr. D discussed Article 19 (Confidentiality); Article 20 is so simple even a caveman can understand it (thank you GEICO). Seriously folks, Article 20 is a one-sentence, one-paragraph Article that basically states that Competent Authorities shall cooperate with each other; and when deemed necessary and appropriate, share information. That being said, the primary concept that device manufacturers need to glean from this edition of DG is that the Competent Authorities, are required to share information. It doesn’t get any easier than that to comprehend.
What IVDD medical device manufacturers need to do
In regards to Article 20, there is really nothing a device manufacturer can do other than ensure devices are safe and effective in their intended use; and compliance to the IVDD is always maintained. Why? Because! Because why Dr. D? Because the Competent Authorities are required to cooperate and share information in accordance with Article 20.
All kidding aside, the regulatory gods in the EU are getting very good at cooperating and sharing information. If a device manufacturer starts racking up the vigilance reports, then that manufacturer can take it to the proverbial bank that all of the Competent Authorities will soon know about the accumulation of reports and the issues driving this negative trend. And the doctor does not mean the European Databank.
There is just one takeaway from this week’s DG, “cooperation.” Yes, Dr. D knows that at times the broken-record factor is high in my weekly ranting. However, some points are just too important; so repetition of a salient concept is the doctor’s way of driving home a point. Remember, “cooperation” is the key term in understanding the fundamental concept of Article 20. Broken-record time again “cooperation” amongst Competent Authorities is the primary takeaway.
Until the next installment of DG, when Dr. D provides insight and guidance into complying with Article 21 (Amendment of Directives) of the In Vitro Diagnostic Medical Device Directive, a.k.a., IVDD – cheers from Dr. D and best wishes for continued professional success.
- 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 for complying with the European medical device directive – MDD. Charleston, SC: Amazon.
- Devine, C. (2011). Devine Guidance series on complying with the MDD. Published in The 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.
This week’s guidance is all about 'keeping secrets' and has three takeaways: having a signed contract and NDA in place; properly labeling all confidential information; and knowing that all information cannot be categorized as confidential.
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.
Article 2 of the IVDD establishes the salient requirements with which IVD devices need to comply to gain entry into the EU. Remember, there is no such thing as minimum compliance, or maximum compliance; it's just compliance.
For this edition of DG, there is just one takeaway: there is never a good reason to have product in the European device market with a wrongly-affixed CE Mark.