The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7. It is clear that the EU is upping its game on vigilance with the ongoing criticism on the CE system for medical devices, whether warranted or not, in mind. If you ask me, I think the system is good on paper but the execution can be much improved. We will have to see where the currently ongoing revision takes us. Snippets of the text are now circulating amongst stakeholders, but a complete proposal is yet to be seen and no one is sure what consequences the PIP scandal will have for vigilance requirements in text that will be proposed and how this proposal might be amended in the European Parliament. In all permutations it’s however safe to assume that the vigilance requirements will become a lot stricter, much more mandatory and very much more prescriptive.
So, what is new in this vigilance MEDDEV? In the words of the document itself:
“Revision 7 of MEDDEV 2.12-1 incorporates two new Report Forms (Annex 6-Manufacturer’s Periodic Summary Report and Annex 7- Manufacturer’s Trend Report Form) and updates two existing Report Forms (Annex 3 and Annex 4).”
These forms are convenient and follow GHTF state of the art. But that’s not all, there is a lot more to this document. Check out the compare I made of this version with the earlier one that shows a lot of interesting little updates and some major ones.
- The extended geographic scope to Turkey is important. Although you might argue that everyone should be aware of this already, I am sure that many will not be. It just shows how the 1963 customs union agreement between the EU and Turkey continues to have new consequences that also impact on medical devices regulation, like for example the right of Turkey to appoint notified bodies and whether Turkish manufacturers need authorised representatives for the EU that the Commission described in guidance for the first time in early 2010.
- Eudamed obligations for the authorities and the consequences have now been embedded in the guidance document.
- The MEDDEV refers to the newer GHTF SG2 document N54 ‘” Global Guidance for Adverse Event Reporting for Medical Devices” for further guidance on reporting obligations” rather than the older document GHTF/SG2/N36 Manufacturers Trend Reporting of Adverse Events from 2003.
- The FSCA part mentions that an FSCA can also include follow up of patients, users or others (see § 4.6), which should not be a surprise for a responsible manufacturer, and follow up of patients of course being the ethical thing to do in line with ISO 14155 principles.
- Small update on what does not constitute a reportable incident: “an intervention by the user or an immediate remote intervention by the manufacturer allowed the [device] to resume the analysis, resulting in correct results.” (see § 22.214.171.124)
- The examples of reportable incidents have been expanded upon (see § 10.1) with specific examples of reportable FSCAs, for example correction of software bugs.
The revised guidance will be applicable as of 15 June 2012, according to the MEDDEV.