The Notified Body Operations Group (NBOG) published some new NBOG Best Practice Guides at the end of 2014. One of these guidance documents deals with renewal of EC product certification, and another one with reporting requirements for substantial changes. Both papers were added to the series of Decisions of the Medical Device Experience Exchange Group (EK-Med) of the German Central Authority of the Laender for Health Protection with regard to Medicinal Products and Medical Devices (ZLG).
NBOG BPG 2014-1 (EK-med 3.9 B15)
NBOG BPG 2014-1 “Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general rules” contains information on the renewal of EC product certifications (EC design examination certificate, EC type examination certificate). It describes the duties of the Notified Body with respect to the renewal process and the information that must be submitted to the Notified Body.
NBOG BPG 2014-3 (EK-med 3.9 B31)
NBOG BPG 2014-3 “Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System″ describes the changes to the quality system or products for which reporting to the Notified Body is mandatory.
Based on the criteria given in the document the manufacturer decides according to his procedure whether a change is regarded substantial and is therefore subject to reporting requirements. The manufacturer informs the Notified Body already of any plans to implement substantial changes in advance of putting them into practice. The document gives several examples of changes that are and are not subject to reporting requirements.
Generally speaking, the Notified Body must be informed about of any changes that may impact the conformity with the general requirements of the Directive. One example of a substantial change would be a new crucial supplier. Changes to the design specifications may be substantial if they affect the indications for use or the performances of the device or raise new safety and performance issues.