When we understand that profitability is a vital part of the equation, it’s easy to see why Sustainability is a challenge worth embracing. By optimizing an existing design, or redesigning to minimize disposable elements, we can make a significant and positive difference.
The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.
Branding professionals and consumer product designers have known about the importance of psychology and self-expression for a long time; these aspects should be as important when designing medical devices.
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and can take away the certification; the CE Mark of registration belongs to the notified body; if a certificate is withdrawn, manufacturers must remove the CE Mark of conformity; and Competent Authorities can suspend or revoke a certificate if the devices are found to be unsafe or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.
This week focuses on Article 13 of the Medical Device Directive that delineates the requirements for “ Decisions with Regard to Classification and Derogation Clause .” The only takeaway the doctor is offering from this edition of DG is to read the Directive and understand the implications each of the Articles and Annexes have on your organization, as understanding the context of device regulations, or the MDD, is synonymous with sustaining regulatory compliance.
Article 12a of the Medical Device Directive (MDD) delineates the requirements for “Reprocessing of Medical Devices.” Is the practice of reprocessing single-use devices safe and effective? Generally speaking, reprocessors believe the practice is safe, device manufacturers, not so much. The reprocessing of medical devices is a widely-accepted practice; however, the doctor questions the validity or reprocessing of devices clearly marketed as single-use, by the manufacturer.