Tag Archives: CE Marking

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

MDD – Article 19

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

Article 19 of the Medical Device Directive delineates the requirements for “Decision in Respect of Refusal or Restriction.” There are two takeaways: One, Member States must provide rationale in regards to decisions made that result in market withdrawals, refusals, and restrictions; and two, device manufacturers and/or their authorized rep shall have the opportunity to consult with the Member State in regards to the decisions made.

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

MDD – Article 18

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

This week’s edition of Devine Guidance is all about the (CE) mark, the whole mark, and nothing but the mark. There’s just one takeaway: Never affix a CE Mark on device packaging until written approval and certification is received from the device manufacturer’s notified body.

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

MDD – Article 17

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

This week discusses the requirements for “CE Marking.” Devices entering into commerce within the EU, unless identified as custom-made or for a clinical investigation, require a CE Marking that indicates conformity to its essential requirements; the device manufacturer cannot affix the CE Marking until certification is issued by their notified body; the CE Marking must be visible and legible; and it cannot be altered, changed, improved upon, hidden, obstructed, defaced, or augmented in a manner that would…

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