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.
The Medical Device Directive encompasses a far more complex array of documents than the Quality System Regulation. The major takeaways from this edition of DG are: (a) significant changes made to the definitions of the MDD (21 March 10) should be clearly understood; (b) PPE requires a stand-alone and unique ERC; (c) depending on the application, software is now in scope of the MDD; and (d) combination devices require compliance to requirements delineated in multiple Directives.
Dr. D will dissect the MDD in 2011. The MDD is far more complex and in this first article in the series, I present a 47,500-feet summary. The number one takeaway from this edition of Devine Guidance is that a CE Mark is required for product to enter the EU. No CE Mark, no product sales in Europe!
The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).
Over the past two months, Dr. D has focused on supplier management from a quality and regulatory perspective. However, the successful execution of a well-defined supplier-management system, and the overall organizational success within the medical device industry, is premised on a strong cross-functional approach to quality. It takes a collegium (may need to look it up) of dedicated professionals, in multi-functional roles, to ensure all aspects of the supplier management system function efficiently. In…