Tag Archives: Chris Devine

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

IVDD Article 14 – The Derogation Clause

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

There are two takeaways from this week: One, Member States retain the right to request revisions to the list of devices delineated under Annex II of the IVDD, and pursue device conformity via the derogation from provisions established by Article 9; and two, the Commission will not blindly make a decision and will review available device information, including vigilance procedures, prior to rendering an opinion.

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

IVDD – Article 12

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

The regulatory authorities in the EU are getting much better at managing the flow of information as it pertains to device manufacturers, device registration, certificates, and vigilance reporting. Prior to May 2011, use of the EUDAMED was strictly voluntary; now, however, it is mandatory and the Competent Authorities, from each of the Member States, are required to input data into the databank.

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

IVDD – Article 10

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

Article 10 (Registration of Manufacturers and Devices) delineates the notification requirements in regards to the Competent Authorities located in each of the Member States; and the need to have a European Authorized Representative, with a valid European address, if a manufacturer does not have a registered place of business in the EU.

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