Hi Anon, let's get the terminology right first. The Blue Guide is guidance so it does not 'apply' by itself. It is a tool to understand concepts from New Legislative Framework legislation from the EU, among which the MDR.
The MDR is a regulation with force of law, so this does 'apply'. The MDR applies in the Union (see article 1 (1) MDR). This concept of Union is not the same as the EU, as is explained in the Blue Guide. The Union consists of the EU member states, the additional EEA member states (Iceland, Norway, Liechtenstein) and Turkey (see also Blue Guide). The UK has recently left and the Swiss did not want a new MRA so they are also out for MDR (and for IVDR end of this month).
The MDR would only apply in New Caledonia if New Caledonia is part of the Union. The Blue Guide dates back to 2016, so it may be outdated. Good to check therefore if at this date New Caledonia is part of the Union. The EU works with two concepts relating to territories outside Europe that have a link with EU member states, neither of which is overseas territories. Rather, the EU uses 'outermost regions' and 'overseas countries and territories' (OTCs). Outermost regions (ORs) are part of an EU member state AND part of the EU, so part of the Union for MDR (e.g. French Guiana). OTCs are part of an EU member state but due to internal choices of that member state not part of the EU, so not part of the Union for the MDR (e.g. the Dutch Antilles and Greenland). There are other permutations, such as Svalbard / Spitsbergen, which is part of a Union member state (Norway) but not part of the Union for the MDR (because of internal Norwegian choices).
Back to New Caledonia. This is not an OR but an OTC: ergo, not Union, so no automatic application of EU law, so no automatic MDR.
MDR might apply in that country on other basis, like an MRA (Switzerland) or customs union 'plus' (Turkey). However, the EU has no MRA or similar arrangement with New Caledonia. Then it is up to the local choices. New Caledonia may regulate for itself that incidents must be reported to the ANSM (since they are French OTC anyway) by MDR standards (applicable in France so convenient). But this does not mean that the MDR applies there. New Caledonian law applies, which mimics the MDR and relies on French institutions for implementation. New Caledonian law can however provide differently too because they are not bound by the MDR as regulation, e.g. that you have to wear a special hat when filling in a MIR form for New Caledonia.
So formally speaking you would be only complying with local New Caledonian law, not the MDR and not with the Blue Guide.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
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Original Message:
Sent: 13-May-2022 02:39
From: Anonymous Member
Subject: Blue Guide Versus MDR - Overseas Territories
This message was posted by a user wishing to remain anonymous
Hi All,
Can anybody advise if the Blue Guide still applies to Overseas Territories with regard to reporting of serious incidents. We have been advised that ANSM have an arrangement for New Caledonia and reports for NC should be submitted to them. However, NC is not on the list of overseas territories in the Blue Guide that apply.
Per Article 89 of the MDR it states:
Member States shall take the necessary steps to ensure that any information regarding a serious incident that has occurred within their territory, or a field safety corrective action that has been or is to be undertaken within their territory, and that is brought to their knowledge in accordance with Article 87 is evaluated centrally at national level by their competent authority, if possible together with the manufacturer, and, where relevant, the notified body concerned.
I would be interested to hear what members think about this. Are we compliant if we follow the Blue Guide or not?
Thank you.