XRAY_3121
Compliance and Regulatory Rx Distributor
Hi all,
I work for a company that has no design and development files (they've been making same product with no changes for 50+ years - Lead aprons, dental xray film, etc.). We just had MDSAP audit under Annex II of MDD, so these files were expected. In my initial response I said we would remove the requirement from the scope of the audit - but was told:
"The company decision to exclude the device is not sustained based on the regulatory requirements about design process => do all countries regulations allow to exclude design for all potential device classifications. What impact will this decision have on the actual or expected certificates ?"
My updated response proposal:
Design and development will be excluded from the scope of the quality management system and we request to receive CE certification under MDD Annex V (not II) which should have been initially requested. The design and development is excluded because there are no design activities performed on the devices. The devices are grandfathered/ legacy devices and there are no design changes.
Brazil and Australia will be removed from scope and we will not sell to these countries.
All of our devices in US are class I and only the intraoral film is a Class IIa in EU (and Australia I believe).
My question is does this seem acceptable, does only Brazil and Australia REQUIRE this??
Am I missing any type of exception or technicality based on the type of product?
Thanks I really appreciate it!
Matthew
I work for a company that has no design and development files (they've been making same product with no changes for 50+ years - Lead aprons, dental xray film, etc.). We just had MDSAP audit under Annex II of MDD, so these files were expected. In my initial response I said we would remove the requirement from the scope of the audit - but was told:
"The company decision to exclude the device is not sustained based on the regulatory requirements about design process => do all countries regulations allow to exclude design for all potential device classifications. What impact will this decision have on the actual or expected certificates ?"
My updated response proposal:
Design and development will be excluded from the scope of the quality management system and we request to receive CE certification under MDD Annex V (not II) which should have been initially requested. The design and development is excluded because there are no design activities performed on the devices. The devices are grandfathered/ legacy devices and there are no design changes.
Brazil and Australia will be removed from scope and we will not sell to these countries.
All of our devices in US are class I and only the intraoral film is a Class IIa in EU (and Australia I believe).
My question is does this seem acceptable, does only Brazil and Australia REQUIRE this??
Am I missing any type of exception or technicality based on the type of product?
Thanks I really appreciate it!
Matthew