Member States shall comply with the IVDD. Comply, is such a simple word (six letters, two syllables). According to Merriam Webster’s Dictionary, comply is an intransitive verb meaning to conform, submit, or adapt (as to a regulation). Guess What? Simply stated, Articles 23 and 24 are telling Member States to conform, submit, and adapt.

Manufacturers need to know that Member States are required to comply with the IVDD. Who knew? Employing the doctor’s bourbon logic, that would mean the manufacturers of devices covered under List A or List B of Annex II shall comply with the Directive as well. Wow, the doctor is really on a roll this week. All kidding aside, Articles 23 and 24 are extremely important as they actual drive the establishment of the IVDD as European law; and the overall applicability of the IVDD for each Member State.

What IVDD medical device manufacturers need to do 

From a device manufacturer’s perspective, knowing that Articles 23 and 24 of the IVDD exist should suffice. As the doctor previously stated, through the use of bourbon logic, since the application of Articles 23 and 24 has resulted in the IVDD being scripted into EU law, you can take it to the bank that it is applicable for device manufacturers.

That being said, the best advice Dr. D can offer is to start preparing for the proposed changes coming to the IVDD. Device re-class (A through D); more devices requiring notified body oversight; additional in-house testing requirements (subject to essential requirements); specific requirements for point-of-care tests; clinical evidence (clinical validity); and companion diagnostics (demonstration of clinical utility) changes are in the proverbial pipeline. If all goes as expected, 2013 will be an interesting year as these changes take effect. 

Since Articles 23 and 24 really do apply to the Member States and not so much for the device manufacturers, Dr. D took the opportunity to wheel out the old podium and pontificate, but only for a little bit. The takeaway from this week’s guidance is really imbedded in the future. What in the heck does that mean doctor?

I forgot to tell the readers that Dr. D is clairvoyant; and using the doctor’s power to see into the future; Dr. D has a dire prediction. The manufacturers of devices, approved under the IVDD, will experience much angst, pain, and sorrow, if they fail to prepare and take steps to ensure compliance to the Directive is attained, post amendment. Wait, the doctor is looking into his crystal ball and sees visions of CE marks being removed from device packaging. In the background, the doctor also sees the tears slowly rolling down the face of a Chief Jailable Officer (CJO). Please prove Dr. D wrong and do not be that CJO.

Until the next installment of DG, when Dr. D provides insight and guidance into complying with Annex I (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.