Tag Archives: IVDD

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Introduction to the Japanese Medical Device Market

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Epilogue

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

Continue reading

Devine Guidance

IVDD Annex IX

By Dr. Christopher Joseph Devine

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!”

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!”

Continue reading

Devine Guidance

IVDD Annex VIII

By Dr. Christopher Joseph Devine

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.

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.

Continue reading

Devine Guidance

IVDD Annex VI (EC Verification)

By Dr. Christopher Joseph Devine

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.

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.

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Annex III Declaration of Conformity

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

Continue reading

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

IVDD Annex II

By Dr. Christopher Joseph Devine
Dr. Christopher Joseph Devine, President, Devine Guidance International

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.

Continue reading