Article 2 of the IVDD establishes the salient requirements with which IVD devices need to comply to gain entry into the EU. Remember, there is no such thing as minimum compliance, or maximum compliance; it’s just compliance.
There are four fundamental differences associated with Article 1 of the IVDD versus the MDD. It is incumbent upon device manufacturers to comprehend these fundamental differences along with definitions specific to the IVDD to support the successful entry of in-vitro devices into the European market.
This series of articles will be premised on the IVDD.The primary takeaway from this week’s edition is that there are significant similarities between the MDD and the IVDD. However, there are also several differences that make the IVDD appear quirky. With revisions to the IVDD looming on the horizon, ongoing compliance with this Directive will continue to be a challenge.
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.