Article 18 does provide for an open channel, ensuring lines of communication exist between the 27-Member States, their Competent Authorities, the offending device manufacturer, and the device manufacturer’s European Authorized Representative.
For this edition of DG, there is just one takeaway: there is never a good reason to have product in the European device market with a wrongly-affixed CE Mark.
The regulatory gods in the EU like their CE Mark as is, so there is no need for improvement. In fact, the notified bodies are mostly in agreement (a rare event indeed) that there needs to be consistency in regards to CE mark construction and visibility.
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.
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.
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…