DG SANCO, NBOG Guidance & Registration Italy Medical Devices
BfArM has a new PDF form for vigilance which fulfils the new German Requirements for incident reporting which became mandatory on March 21, 2010. (To provide some cursory background information, Germany, when they transposed Directive 2007/47/EC, included a new requirement on vigilance which mirrors MEDDEV 2.12.1, Revision 6.)
As a related housekeeping note, remember to reference Revision 6 of the MEDDEV if citing this guidance in any of your company documents and procedures. The Incident Report Form is available on this web page. Again, as another related reminder, Competent Authorities expect Emergo Europe, as the Authorized Representative, to submit the Incident and Field Safety Corrective Action Report Forms to the relevant Competent Authorities.
In other organizational news, the regulatory home of medical devices (and, incidentally pharmaceuticals as well) has moved from the EU Directorate General (DG) Enterprise to DG SANCO, Health and Consumer Policy. While this structural move has yet to impact industry, it will be an interesting topic to follow, as we may see increased emphasis on consumer and patient safety, as opposed to the more business-focused model of the DG Enterprise.
In addition to the regulatory updates above, the Notified Body Operations Group (NBOG) has released three new guidance documents: Checklist for audit of Notified Body's review of Clinical Data / Clinical Evaluation, which is a derivation of MEDDEV 2.7.1, Revision 3 (as described previously). A full listing of original source NBOG documents is available on the NBOG Website.
The NBOG Guidance for Notified Bodies auditing suppliers to medical device manufacturers may be of particular interest since it addresses some of the quality assurance system changes mandated by Directive 2007/47/EC. Figure 1 in Appendix 1 is from GHTF guidance on the topic (SG3/N17/2008). Appendix 2 includes a list of elements which should be checked and assessed by the Notified Body related to supplier agreements. The Checklist on Clinical Data is a comprehensive document and also serves as a valuable resource.
The European Commission announced that Eudamed, the databank for medical devices, will be mandatory for Competent Authorities as of May 1, 2010. We'll publish more on this in the future, but note that it will not be publicly accessible.
Registration Italy Medical Devices (not IVDs)
The other salient update which gave rise to this correspondence is that new changes to the registration requirements for medical devices in Italy have been enacted; namely that registration is no longer required for Class I devices that have European Authorized Representation located outside of Italy.
Decreto 20 febbraio 2007 required manufacturers or their designated entities to register their medical devices (except IVDs which need to be notified through a different process) in the Italian Ministry of Health Database, if the medical devices are to be sold in Italy. The complete listing of all registered devices is termed the "Repertorio." The deadline for the re-registration of devices introduced to Italy prior to May 1, 2007 was postponed once again until March 31, 2010. This delay had been to give the Italian Ministry of Health additional time to simplify the database (Repertorio) and modify the current expectations of the National Directory. Once again, there has been a postponement. As a result of a March meeting of Ministry of Health officials in Italy, devices currently marketed in Italy (that are subject to re-registration) now have until May 5, 2010 to re-register, and effective immediately, devices new to the Italian market are subject to the registration requirements delineated in the text below.
Decreto 21 dicembre 2009 went into effect on February 6, 2010, and supersedes Decreto 20 febbraio 2007. The major change is that Class I medical device registrations with the Italian Ministry of Health are no longer required for manufacturers whose European Authorized Representative is located outside of Italy. (Note that registrations are still required for Class I devices of manufacturers whose European Authorized Representative is located in Italy.) In addition, Decreto 21 dicembre 2009 has lessened some of the requirements for registration of Class IIa, IIb, and III medical devices, as well as active implantable medical devices; namely, the extensive details that had previously been required for entry into the Repertorio have diminished.
The Italian National Health Service, Servizio Sanitario Nazionale, or SSN, is the healthcare system in Italy. Only devices that are registered are available to the SSN. Thus, although Class I devices whose manufacturers have European Representation outside of Italy are exempt from registration requirements, if they wish to market their devices within the SSN, they must still register their devices.
To review: on Italian Registrations
If you are a manufacturer with European Authorized Representation OUTSIDE of Italy:
- Class I registrations are not required, unless the manufacturer would like to make their Class I devices available within the SSN, in which case device registration is required.
- Registrations are required for Class IIa, IIb, III medical devices.
- If your products were introduced prior to May 1, 2007, you must go through the steps of re-registering with the Italian Ministry of Health no later than March 31, 2010.