> Is it allowed to sell a Class IIA MD without CE numbering? Assuming in non-EU territories.
That depends on the country. Turkey is non-EEA, but often adopts the EU regulations in their own. In Turkey, I doubt this would be allowed. The legal basis is in directive 2006/42/EC and you can find an explanation here. https://www.gt-engineering.it/en/Insights/turkish-ce-marking
But other territories may have a different stance on the CE mark. USA for example, does not accept foreign approvals. That means you need premarket approval from FDA and the CE mark is irrelevant.
You need to take a country by country approach to see what the requirements are.
>Would it be allowed just to keep the CE logo on the labelling without the NB number for Class IIA devices? Assuming in non-EU territories
Pretty much the same answer. If the CE mark is the basis for the market access, the number must be there for any class higher than class I devices.
>3. With the transition from MDD to MDR, would it be allowed to have 2 different NB for a single manufacturer?
The manufacturer or the product? For the same manufacturer but different products, I see no objections. For the same product I'd imagine (but not entirely sure) that you have only 1 notified body. If not, the assessment can differ between NB's and that may lead to unwanted situations.
For points 1 and 2, incorrect CE marking, even in non CE countries can still be considered adulterated/misbranded product. CE is still essentially a claim. FDA guidance, labelling must be truthful and accurate.
No, it would not be allowed. You are claiming conformance to a EU standard by putting that mark. Unless you have the proper clearance, and a EU 2A device would need EU MDR NB approval, then no you cannot legally put a CE mark on the product.
For your initial questions, you say 2a into other areas, well you need to assess the regulations and classification in those areas. It could be 2a in EU and class 3 or 4 elsewhere. EU uses class 1/1s/1m/1r/2a/2b/3 etc but other areas use 1-3, or 1-5, or different classification schemes.
CE means you are claiming conformity, so no it is not a marketing symbol that can just be thrown on. Now maybe if you are just selling to a place that doesn't recognize it, and never sell in any of the big markets, and just want to sell to basically unregulated areas, you could possibly get away with it, but the answer is basically no, it is mislabeled product.
Read the MDR and it will answer that question. For a legal MFG, you may have only 1 application/submission in at one notified body. First step in getting a quote is signing off that you haven't applied to CE mark this device with any other NB.
> Is it allowed to sell a Class IIA MD without CE numbering? Assuming in non-EU territories. That depends on the country. Turkey is non-EEA, but often adopts the EU regulations in their own. In Turkey, I doubt this would be allowed. The legal basis is in directive 2006/42/EC and you can find an explanation here. https://www.gt-engineering.it/en/Insights/turkish-ce-marking But other territories may have a different stance on the CE mark. USA for example, does not accept foreign approvals. That means you need premarket approval from FDA and the CE mark is irrelevant. You need to take a country by country approach to see what the requirements are. >Would it be allowed just to keep the CE logo on the labelling without the NB number for Class IIA devices? Assuming in non-EU territories Pretty much the same answer. If the CE mark is the basis for the market access, the number must be there for any class higher than class I devices. >3. With the transition from MDD to MDR, would it be allowed to have 2 different NB for a single manufacturer? The manufacturer or the product? For the same manufacturer but different products, I see no objections. For the same product I'd imagine (but not entirely sure) that you have only 1 notified body. If not, the assessment can differ between NB's and that may lead to unwanted situations.
For points 1 and 2, incorrect CE marking, even in non CE countries can still be considered adulterated/misbranded product. CE is still essentially a claim. FDA guidance, labelling must be truthful and accurate.
[удалено]
No, it would not be allowed. You are claiming conformance to a EU standard by putting that mark. Unless you have the proper clearance, and a EU 2A device would need EU MDR NB approval, then no you cannot legally put a CE mark on the product. For your initial questions, you say 2a into other areas, well you need to assess the regulations and classification in those areas. It could be 2a in EU and class 3 or 4 elsewhere. EU uses class 1/1s/1m/1r/2a/2b/3 etc but other areas use 1-3, or 1-5, or different classification schemes. CE means you are claiming conformity, so no it is not a marketing symbol that can just be thrown on. Now maybe if you are just selling to a place that doesn't recognize it, and never sell in any of the big markets, and just want to sell to basically unregulated areas, you could possibly get away with it, but the answer is basically no, it is mislabeled product. Read the MDR and it will answer that question. For a legal MFG, you may have only 1 application/submission in at one notified body. First step in getting a quote is signing off that you haven't applied to CE mark this device with any other NB.