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.
Article 5 of Council Directive 93/42/EEC, a.k.a., the Medical Device Directive (MDD) defines the requirement for “reference to standards.” For this week, there is just one takeaway. The notified bodies like the harmonized standards. They will make the lives of device manufacturers miserable if the manufacturers fail to embrace these same standards.
Article 4 of the Medical Device Directive establishes the requirements for “free movement, devices intended for special purposes.” This week’s Devine Guidance will provide some insight needed for complying with Article 4 of the MDD. In my opinion, the language issue will continue to be a challenge for the device industry, for the foreseeable future.
There are three takeaways from this week’s edition: one, Article 3 of the MDD establishes the need for compliance to Essential Requirements with a mandate to comply with Annex I; two, completion of the ERC is not optional, it is a requirement, and you are expected to keep the checklist current; and three, Dr. D strongly suggests adhering to harmonized standards.
Once a notified body is selected, the purchase order issued, and the contract signed, can device manufacturers affix a CE Mark and start shipping product into Europe? The answer to this question would be a resounding ‘no.’ And this edition of DG will explain why.