##  [Medical Writing Toolkits Package](/medical-writing-toolkits-package) 

# Enhanced Compliance Packages

#### Basic, Standard & Premium Kits for Full EU MDR/IVDR Alignment

Accelerate your Regulatory readiness with Freyr’s class-based toolkit bundles. Whether you’re targeting low-risk or high-risk Medical Devices (MDV) or In Vitro Diagnostic Devices (IVD), our **Basic, Standard, and Premium Kits** provide the precise documentation needed for both initial evaluations and ongoing post-market surveillance—fully aligned with EU MDR 2017/745 and EU IVDR 2017/746.

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    End-to-End Documentation
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    Expert-Authored Templates
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    Efficient, Bundled Access











## Compare and Choose the Right Toolkit for Your Product Class



### Medical Device Packages

Basic Kit for MDR Class I / IIa

 

- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- Post Market Surveillance Plan
- Post Market Surveillance Report



Price

$1,250.00

 

 

   Quantity  

 

  



 

 



Standard Kit for MDR Class IIb 

 

- **All templates from Basic +**
- Periodic Safety Update Report (PSUR)
- Literature Search Report (LSR)
- Clinical Evaluation SOP
- Post Market Surveillance SOP



Price

$2,000.00

 

 

   Quantity  

 

  



 

 



Premium Kit for MDR Class III / Implantable Devices

 

- **All templates from Basic + All templates and SOPs from Standard +**
- Summary of Safety and Clinical Performance (SSCP)
- Post Market Clinical Follow-up (PMCF) Plan
- Post Market Clinical Follow-up (PMCF) Report



Price

$2,500.00

 

 

   Quantity  

 

  



 

 



### IVD Packages

Basic Kit for IVDR Class A / B

 

- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Post Market Surveillance Plan
- Post Market Surveillance Report



Price

$1,250.00

 

 

   Quantity  

 

  



 

 



Standard Kit for IVDR Class C (non-high-risk)

 

- **All templates from Basic +**
- Periodic Safety Update Report (PSUR)
- Literature Search Report (LSR)
- Performance Evaluation SOP
- Post Market Surveillance SOP



Price

$2,000.00

 

 

   Quantity  

 

  



 

 



Premium Kit for IVDR Class C & D (high-risk)

 

- **All templates from Basic + All templates and SOPs from Standard +**
- Summary of Safety and Performance
- Scientific Validity Report
- Clinical Performance Report
- Analytical Performance Report
- Post Market Performance Follow-up Plan
- Post Market Performance Follow-up Report



Price

$3,000.00

 

 

   Quantity  

 

  



 

 



 

 



 











## Need Help Selecting the Right Kit?

If you are unsure of whether your product fits into Basic, Standard, or Premium documentation needs, our Regulatory experts are here to help. Reach out at [sales@freyrsolutions.com](mailto:sales@freyrsolutions.com%0A)