The company’s Bakken Research Centre in the Netherlands is centrally located for technology development and collaboration with physicians.
Critical subcontractors and crucial suppliers will be subject to unannounced audits by notified bodies under the revised European device regulations. Richard DeRisio of TÜV Süd provides more details in this presentation.
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!