Article 20a of the Medical Device Directive delineates the requirements for “Cooperation.” While the term almost sounds like an oxymoron, much like “military intelligence” or “genuine artificial jumbo shrimp,” there is just one takeaway for this edition of DG: this directive requires the Competent Authorities, from each of the Member States, to cooperate – period!
Article 20 of the Medical Device Directive delineates the requirements for “Confidentiality.” There are three takeaways from this edition: Under the Directive, reasonable attempts at confidentiality are required to be sustained; three categories of information are not protected under the confidentiality clause—registration, user, and certification information; and the best way an organization can protect itself in regards to the managing of proprietary information is through a well-documented policy augm…
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…
Article 16, of the Medical Device Directive delineates the requirements for “Notified Bodies.” The notified body is authorized to issue certification, and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or ineffective.
Article 15 provides guidelines for device manufacturers that have product or are planning to introduce product, into an EU Member State, for the purpose of conducting a clinical investigation. Failure to comply with this will result in device manufacturers failing to obtain approval to pursue clinical investigations within the EU, and in today’s increasingly complex medical device market, not performing a clinical investigation will result in device manufacturers being shut out of the European market.
Article 14b, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for “Particular Health Monitoring Measures.” There are two takeaways from this edition of DG: One, a robust design and development process will lead to medical devices that are safe and effective; and two, devices that are safe and effective and meet their essential requirements seldom, if ever, will run afoul of Article 14b of the MDD.
Article 14a, of Council Directive 93/42/EEC delineates the requirements for “European Databank.” This week’s edition of Devine Guidance relates to the European Union (EU) and their need to develop a standardized format for data collection associated with medical devices; and a receptacle for collecting voluminous amounts of data. The takeaway for device manufacturers is that the EU continues with their pursuit of standardization in supporting the establishment of effective data management, with the devel…
The takeaway for this week’s edition is extremely simple; however, understanding Article 14 is vitally important. Device manufacturers need to retain a European Authorized Representative in order to place medical devices into commerce in the EU with the following in place: a contract with the EU Authorized Rep; an accurate product list on file with the EU Authorized Rep; and the EU Authorized Rep’s address on the product labeling.