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.
This week, we discuss Annex II (EC Declaration of Conformity – full quality assurance system) of the Medical Device Directive, which delineates the regulatory requirements necessary for compliance with the Directive employing an acceptable quality assurance system. Annex II is really a straightforward document with requirements relatively easy to comprehend. There are three major components: (a) application and approval of a QMS by a notified body; (b) application and approval of the actual device applic…
Device manufacturers already shipping into the European Union understand the ramifications of having product that fails to meet essential requirements or a quality system failing to meet the requirements detailed within the annexes associated with the Medical Device Directive. It is the opinion of Dr. D, that the Annexes associated with the MDD is where the proverbial rubber hits the road. This week, we cover Annex I of the MDD.
This edition of Devine Guidance provides guidance for the final two Articles associated with the Medical Device Directive. Article 22 mandates that Member States are required to comply with the MDD no later than 01 July 1994, and Article 23, while not addressed to device manufacturers, is addressed to Member States. Device manufacturers need to know that there are 23 Articles; however, in regards to Articles 22 and 23, they have zero influence on device manufacturers so please, just “forgetta-bout-it.”
Article 21 of the Medical Device Directive delineates the requirements for “Repeal and Amendment of Directives.” It is incumbent upon device manufacturers to ensure all of these changes have been captured and adequately addressed within your organizations. If your organization has not implemented these changes, Dr. D suggests you “Get er done.”