Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.
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 while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.
Dr. D has just one takeaway from this edition of DG; “Just comply baby!” It does not get any easier than that, well maybe not that easy.
The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”
This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.
Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.
This weeks guidance delineates the steps that a device manufacturer must perform in the pursuit of making application to their notified body. The end result of a successful application process will be the authorization to affix the CE mark of registration onto product packaging and the entry of product into commerce within the EU.
Annex II of the IVDD is critical as it ultimately drives the path for establishing and complying with essential requirements, and hopefully, the eventual approval from your notified body. And significant changes to Annex II are coming.
From Dr. D’s standpoint, similar to 93/42/EEC (the MDD), the Annexes are where the proverbial rubber actually meets the road for device manufacturers.
It really does not get any easier than these two articles when discussing the virtues and implications associated with compliance to this Directive. Enjoy!