Annex XII (CE Marking of Conformity) of the Medical Device Directive is all about the Mark, the whole Mark, and nothing but the Mark. The regulatory gods in the EU like their CE marking of conformity just as the mark is depicted in Annex XII. Dr. D’s best advice is to abide by the Annex and leave perfection alone.
The takeaway from this edition of DG is extremely simple. Device manufacturers wishing to enter into the European device market must have a notified body. And under Annex XI of the Medical Device Directive, device manufacturers can take some comfort in knowing that notified bodies are also held to a high standard.
The takeaway from this week’s edition on MDD Annex X (Clinical Evaluation) is simple: the expectations of the Competent Authorities are that medical devices should always be safe and effective while conformity to essential requirements is achieved.
The take away from this week pertains to the accuracy of the declaration: device manufacturers need to ensure all of the information depicted within the declaration is factual and accurate, including those relating to rules and classifications.
Custom-made and investigational devices must be designed, manufactured, inspected, and tested in a manner that results in a safe and effective device; this means that adequate controls must be in place.
The message of compliance remains consistent and will never change. The goal of any device regulation and regulatory body, regardless of the country of origin, is the protection of public health by ensuring medical devices are safe and effective.
The takeaway from this week is simple: regardless of the functional area—design, test, manufacturing, inspection, packaging, labeling, distribution, post-market surveillance, etc., it all starts with the QMS.
The takeaway from this week is simple: medical device manufacturers must design, develop, manufacturer, inspect, test, inspect some more, label, package, affix a CE Mark, ship, and distribute “medical devices that are safe and effective” – period!
Annex IV involves a whole bunch of trust as device manufacturers are expected to self-test and self-verify their devices meet essential requirements.
This week, we discuss Annex III (EC Type – Examination) of the Medical Device Directive. There are two takeaways: Device manufacturers should ensure all of the technical documentation is readily available for their notified bodies during the examination process. And second, remember your responsibilities associated with certificate and data retention – there is a mandatory retention period of either 5 or 15-years, depending on the application of the device.