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!
Consent decrees are expensive. Remember, consent decree and the resulting actions are driven by the courts and all bets are off in regards to when normal business operations will return, if ever. If the process of paying the third-party consultants does not grab the attention of the controller, rest assured the fines levied by the courts should. One final thought, with no new product approvals from FDA on the horizon, your competitors will be thanking you as your customer base and market share quickly be…
So your organization has received a warning letter from FDA – now what? For starters, the agency has quickly upped the ante in regards to taking the next steps in ensuring your organization clearly understands that a continued state of non-compliance is not acceptable. Warning letters are life-changing events for device manufacturers; however, they are recoverable. Dr. D recommends getting legal counsel and industry experts involved when responding to a warning letter, reviewing subsequent correspondence…
There are two options in regards to Form 483s: in option One, an organization can be proactive, accept the Form 483, and treat is as an opportunity for pursuing continuous improvement, while driving compliance to the QSR. In option Two, an organization can ignore the Form 483, and in doing so, be prepared to deal with the proverbial opening of the can of “FDA worms” and the subsequent warning letter that will be issued.
Whether major or minor, complaints require a significant organizational commitment to ensure a fastidious and consistent approach to complaint management. This week’s Devine Guidance will begin analyzing and providing insight and guidance needed for maintaining an effective compliant management system–mainly complying with 820.198, subsections a, b, and c.