PRRC Service Pricing
The Medical Device Regulations (MDR) or the In Vitro Diagnostics Regulations (IVDR) now include regulation on manufacturers having a Person Responsible for Regulatory Compliance
PRRC MDR Services
Our PRRC MDR Services ensures that the companies technical files and regulatory obligations are carried out. This does not mean that the company has to employ a regulatory person to perform this service, as this is unlikely to be a full-time role for a small medical device company.
It is possible to contract out this position to a 3rd party company – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively.
It is possible to contract out this position to a 3rd party company – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively.
Option 1
€
600
/
per month
contract out
- Initial PRRC review & registration *
- 1 Day Product Content Management review and release
- Quarterly traceability report
- Annual stocktake
- Account management
Option 2
€
3000
/
annual
contract out
- Initial PRRC review & registration *
- Annual stocktake
- Product release charged at €600 per shipment (up to a maximum batch size)
- Account management
- Item 3
Additional Services
€
600
/
per quarter
or annual for €1800 (per 5 distributors)
- Distributor management
- Quarterly review of distributors for MDR Article 14 Adherence
- Account Management
- Item 4
- Item 5
- Attention: Prices may vary by market and other factors
-
Assumes registration can be completed using companies existing regulatory procedures and documents.
In the event work is required to bring these documents to standard this will be charged and a day rate of E600
1 +
Years Experience
1 +
Customers
1
distributors
1
warehouse locations
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