Hi Cuffern,
Happy that it opened more opportunity.
Let's summarize again
Case 1: Your office in Europe is the Virtual Manufacturer
- This office will register the product in Europe as if he is the owner of it. So you'll need to provide all the documents as a Real Manufacturer.
- You should consider the OEM as a supplier of the product that you ordered. Audit of the OEM should be included on your procedures.
- You don't need an EU-AR as the legal entity (virtual manufacturer) is located in Europe
- You need a Notified Body to provide you CE certificate and ISO 13485 certificate. So you need also a QMS
- The OEM/Supplier can be also audited as he will be considered as Critical Supplier.
- You'll need to appoint a PRRC (Person Responsible for Regulatory Compliance)
Case 2: Your office in Europe is acting as EU-AR
- This office needs to register in the European Union as Authorized Representative
- In case this office can be also considered as the importer you can have Importer and EU-AR under the same roof
- You don't need a specific ISO 13485 and CE mark certificate as you are not considered as the manufacturer
- You still need to have a PRRC.
This is not an exhaustive list but these are the major things that I recall.
Then it's up to you to choose the best strategy. Tell me what you think.
Happy that it opened more opportunity.
Let's summarize again
Case 1: Your office in Europe is the Virtual Manufacturer
- This office will register the product in Europe as if he is the owner of it. So you'll need to provide all the documents as a Real Manufacturer.
- You should consider the OEM as a supplier of the product that you ordered. Audit of the OEM should be included on your procedures.
- You don't need an EU-AR as the legal entity (virtual manufacturer) is located in Europe
- You need a Notified Body to provide you CE certificate and ISO 13485 certificate. So you need also a QMS
- The OEM/Supplier can be also audited as he will be considered as Critical Supplier.
- You'll need to appoint a PRRC (Person Responsible for Regulatory Compliance)
Case 2: Your office in Europe is acting as EU-AR
- This office needs to register in the European Union as Authorized Representative
- In case this office can be also considered as the importer you can have Importer and EU-AR under the same roof
- You don't need a specific ISO 13485 and CE mark certificate as you are not considered as the manufacturer
- You still need to have a PRRC.
This is not an exhaustive list but these are the major things that I recall.
Then it's up to you to choose the best strategy. Tell me what you think.
We already have an existing CE certificate so in Case 1, I think that would no longer be valid so the new EU virtual manufacturer would need to re-apply for CE marking. Our existing ISO 13485 certification would not be valid either. Getting new certificates is not the end of the world and might be worth it for single-market access - though there are continuity issues to consider.
What I am less sure about for case 1, is what the QMS would look like for the Virtual Manufacturer. Theoretically, could it be a team of one - a PRRC who also doubles up for the rest of the QMS roles? The smallest QMS I have ever worked on had four employees - where the aim in case 1 would be to keep the Virtual Manufacturer as small as possible.
My colleagues are looking at the legal options to see if, by having an EU subsidiary, we can quality as an eu-based manufacturer without the need for a separate Quality certificate and CE Certificate - but I don't see how that is possible. What makes it less clear is that the MDD states that we need a registered place of business in the EU - it doesn't state explicitly that the manufacturer on the label must be the same as the registered place of business in the EU. I am sure this must be defined somewhere - any ideas?