Tag Archives: Council Directive 93/42/EEC

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

MDD – Annex XII

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

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
Devine Guidance

MDD – Annex XI

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

The takeaway from this edition of DG is extremely simple. Device manufacturers wishing to enter into the European device market must have a notified body. And under Annex XI of the Medical Device Directive, device manufacturers can take some comfort in knowing that notified bodies are also held to a high standard.

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

MDD – Annex III

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

This week, we discuss Annex III (EC Type – Examination) of the Medical Device Directive. There are two takeaways: Device manufacturers should ensure all of the technical documentation is readily available for their notified bodies during the examination process. And second, remember your responsibilities associated with certificate and data retention – there is a mandatory retention period of either 5 or 15-years, depending on the application of the device.

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