The European Medical Device Directive or 93/42/EEC regulates which medical devices may be sold in the European market, while 21 CFR 820 is an FDA Quality Systems Regulation is a document that helps manufacturers of medical devices establish and follow a quality system within their company / organization in order to ensure that their manufacturing processes and the resultant products consistently meet and fulfill their applicable requirements and specifications. The 21 CFR 820 (also known as the FDA’s Quality System Regulation (QSR)) determines the cGMP requirements for medical devices.
While both systems accomplish a similar goal: assure the quality and safety of medical devices sold within their borders, they rely on separate authoritative standards to determine whether or not this has been accomplished. Beyond bureaucratic differences, there are other far reaching implications, such as differing auditing practices.
The Two Different Approaches For Compliance
Conforming to the Medical Device Directive is required to attain the CE mark and market a medical product in the European Union. The European Union, in turn, has largely adopted ISO standards to determine regulatory compliance.
EN (European National) ISO 13485 is a regional standard harmonized with the European Union Medical Device Directive, meaning it contains more specific Euro-centric language than otherwise found in the more general ISO 13485 on which it is based. A third party, called a Notified Body, assesses compliance with EN ISO 13485 via audits of a manufacturer’s facilities and practices. Without EN ISO 13485 certification it can be far more difficult, if not impossible, for a manufacturer to demonstrate compliance with the Medical Device Directive.
FDA approval is a necessary component of selling medical products in the US. 21 CFR 820 establishes QSR (Quality System Regulations) that dictate cGMPs that must be followed by a manufacturer of medical devices as part of their overall QMS (Quality Management System). Though ISO 13485 and 21 CFR 820 share many similarities, certification in the former does not necessarily equate with FDA compliance with the latter or approval of the QMS employed. The FDA conducts its own audits and operates under different auspices than a Notified Body and the European Union.
Differences In Notified Bodies and FDA Audits
The rules governing how audits may be conducted are different depending on whether auditors are working at the request of European interests, or if they are directly employed by the FDA. Audits conducted by Notified Bodies are scheduled in advance giving the manufacturer time to prepare, while audits by the FDA can be completely unexpected and unscheduled in the US. In Europe, however, the manufacturer receives notification from the FDA approximately 6 to 8 weeks prior to a proposed inspection by the FDA.
The nature of the visits is different as well. While the Notified Bodies enter with a set and previously discussed agenda, such as to inspect a particular process or department, the FDA will inspect a facility in accordance with that facility’s registration with the FDA e.g. a facility which is registered with FDA as being a foreign exporter of a medical device will be inspected within the scope of that topic. The FDA is also free to prolong the duration of an inspection as it deems necessary.
Same Tasks, Different Regulatory Bodies
The European Medical Device Directive and the FDA both seek to assure the consumer that the medical devices on the market are safe and defect-free. They each rely on different standards in order to reach this goal, but it is imperative device manufacturers understand these differences in order to meet compliance. Failure to do so places increased burdens on firms when bringing products to market.
GxP-CC experts are well-versed in regulatory compliance standards required by the FDA and European Regulatory Authority. Contact them to discuss how they can help you meet the European Medical Device Directive or the FDA’s 21 CFR 820 regulation.