Annex XII (CE Marking of Conformity) of the Medical Device Directive is all about the Mark, the whole Mark, and nothing but the Mark. The regulatory gods in the EU like their CE marking of conformity just as the mark is depicted in Annex XII. Dr. D’s best advice is to abide by the Annex and leave perfection alone.
The takeaway from this week’s edition on MDD Annex X (Clinical Evaluation) is simple: the expectations of the Competent Authorities are that medical devices should always be safe and effective while conformity to essential requirements is achieved.
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.
Article 12, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive delineates the requirements for “Particular Procedure for Systems and Procedure Packs and Procedure for Sterilization Conformity Assessment Procedures.” Article 12 is all about declarations and compliance with Annex II (EC Declaration of Conformity – Full Quality Assurance System) and Annex V (EC Declaration of Conformity – Production Quality Assurance).
Article 11 of the Medical Device Directive aligns the actual classification of devices with the applicable Annex in order to affix a CE mark containing the notified body’s registration number. There are three important takeaways from this week: one, device manufacturers need to understand the link between device classification and the appropriate Annexes; two, notified bodies are permitted to grant application extensions for up to five years and; three, the Competent Authority can grant device entry…
This week we discuss Article 10 of the Medical Device Directive which establishes the reporting requirements for incidents within the European Union, also known as vigilance reports. The key takeaway is that there is an incident reporting system alive and well within the EU. Device manufacturers are expected to act immediately when reports of patient and user injury or death occur.
This week, we discuss Article 9 of the Medical Device Directive that delineates the requirements for Classification. In fact it is Dr. D’s opinion that the European approach to device classification is significantly better than the approach pursued by FDA. Remember, device classification will drive the path for conformity for devices entering the EU, and ultimately, the need for compiling a technical file or a design dossier to support the application process.
Article 8, of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) delineates the requirements for the “Safeguard Clause.” The takeaway from this edition is simple: device manufacturers are expected to react quickly when their devices have been identified as posing a threat to public health and safety within the EU.
This week, we briefly discuss Articles 6 and 7. For this edition, the takeaway is simple, read and understand Articles 6 and 7; however, do not lose sleep worrying over their impact on device manufacturers. Why? Because Articles 6 and 7 pertain to the Commission, the Committee and the establishment of rules for the oversight of standards, period.
