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.