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I agree with Cristoph in response to Anon's question: "I would assume for a class IIb (non-implantable), such a contract would not be required?" MDR Article 61(5) applies only to those device classes specified in Article 61(4), i.e., implantable devices and class III devices. This was the subject ...

I thought VerpackG was limited to 'B2C' transactions, not 'B2B' - is this incorrect? ------------------------------ Roger Gray VP Quality and Regulatory Donawa Lifescience Clinical Studies - Regulatory - Quality Systems AR/UKRP services Italy and UK rgray@donawa.com www.donawa.com ---------------- ...

Thanks for the additional information regarding your interaction with the Commission, Kevin, and for reminder that the change to Annex IX Section 3.5 was made in Corrigendum 1.. Unfortunately, the Commission has made the classic error of making one change without understanding the consequences elsewhere ...

I know we've gone some way from answering the initial question, but I thought I would just make a couple of comments. I agree with Christoph's interpretation of both MDD and MDR, in that you generally only need a QMS certificate (MDD Annex II/MDR Annex IX Parts I and III) unless you have a Class III ...

'System' is a defined term in the MDR: "(11) 'system' means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose;" This should be sufficient to answer your question. Roger Gray Donawa Lifescience  Rome, ...