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

IVDD – Article 4

By Dr. Christopher Joseph Devine
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This edition has two important takeaways: one, without a CE mark, the device cannot enter into commerce in the EEC; and two, the language requirement will continue to be a big challenge for device manufacturers as more countries opt to have labeling and IFUs in their native tongues.

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

IVDD – Article 1

By Dr. Christopher Joseph Devine
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There are four fundamental differences associated with Article 1 of the IVDD versus the MDD. It is incumbent upon device manufacturers to comprehend these fundamental differences along with definitions specific to the IVDD to support the successful entry of in-vitro devices into the European market.

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

IVDD – An Introduction

By Dr. Christopher Joseph Devine
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This series of articles will be premised on the IVDD.The primary takeaway from this week’s edition is that there are significant similarities between the MDD and the IVDD. However, there are also several differences that make the IVDD appear quirky. With revisions to the IVDD looming on the horizon, ongoing compliance with this Directive will continue to be a challenge.

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

MDD – Annex XII

By Dr. Christopher Joseph Devine
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Annex XII (CE Marking of Conformity) of the Medical Device Directive is all about the Mark, the whole Mark, and nothing but the Mark. The regulatory gods in the EU like their CE marking of conformity just as the mark is depicted in Annex XII. Dr. D’s best advice is to abide by the Annex and leave perfection alone.

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

MDD–Article 13

By Dr. Christopher Joseph Devine
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This week focuses on Article 13 of the Medical Device Directive that delineates the requirements for “ Decisions with Regard to Classification and Derogation Clause .” The only takeaway the doctor is offering from this edition of DG is to read the Directive and understand the implications each of the Articles and Annexes have on your organization, as understanding the context of device regulations, or the MDD, is synonymous with sustaining regulatory compliance.

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

MDD–Article 12a

By Dr. Christopher Joseph Devine
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Article 12a of the Medical Device Directive (MDD) delineates the requirements for “Reprocessing of Medical Devices.” Is the practice of reprocessing single-use devices safe and effective? Generally speaking, reprocessors believe the practice is safe, device manufacturers, not so much. The reprocessing of medical devices is a widely-accepted practice; however, the doctor questions the validity or reprocessing of devices clearly marketed as single-use, by the manufacturer.

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

MDD–Article 12

By Dr. Christopher Joseph Devine
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Article 12, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive delineates the requirements for “Particular Procedure for Systems and Procedure Packs and Procedure for Sterilization Conformity Assessment Procedures.” Article 12 is all about declarations and compliance with Annex II (EC Declaration of Conformity – Full Quality Assurance System) and Annex V (EC Declaration of Conformity – Production Quality Assurance).

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