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).
In a perfect world, there would never be a need to handle non-conformances from your supplier base. However, the world of medical device manufacturing is far from perfect (please do not tell the regulators). You may call it fate, destiny, or bad luck, but Dr. D. calls it problem suppliers. Rest assured some of your suppliers will eventually deliver nonconforming product and at some point in the not-so-distant future, I will address managing nonconforming products as a whole. Warning letter violation Vio…
If a supplier scored well on their original selection assessment, or scores well on repeat maintenance assessments—say, a score of 90 percent or above for argumentative sake—and your organization is receiving 100 percent conforming product (yes, imagine a perfect world), what is the value of performing an annual or regularly scheduled maintenance assessment? Dr. D does not see any upside. Now I could write a philippic (yep, look up time again) that takes medical device organizations to task in regards t…
To ensure supplier surprises are kept to a bare minimum, an organization cannot simply rely on thaumaturgy (go ahead and look it up). Supplier performance must be continuously gauged for effectiveness, and a feedback loop created to ensure suppliers are receiving accurate information in regards to their overall performance. Additionally, supplier performance metrics should be included into your management review process. Management must be informed of parlous issues that can result in the need for field…
Welcome back to this sixth installment of Devine Guidance . I am not one to assume a Panglossian view (time to pull out the dictionary again) when dealing with problem suppliers and the need to pursue corrective action. However, at times the ugly SCAR becomes unavoidable. In fact, evidence of effective corrective action, as it pertains to suppliers is a requirement and the FDA, notified bodies, and other regulatory bodies will verify the effectiveness of the approach pursued by your organization. Additi…
Since the concept of writing a weekly blog and actually having a following is somewhat foreign to me, I was not sure what to expect or the reception I would receive writing a weekly column. So far, the support and responses have been overwhelmingly positive; and for that, I would personally like to thank the readers. Additionally, I will continue to write about and provide relevant information associated with supplier quality (four installments remaining) and will eventually begin addressing quality and…
