Pricing

MDRpankki Service Packages

We offer three clear ways to move towards MDR compliance. You can start with a light gap analysis, order complete MDR documentation as a turnkey service, or also build an ISO 13485 quality management system. Each project is priced fixed based on device class and scope – no hourly fees, no surprises.

Gap Analysis

The best choice when you want to know exactly what’s missing and in what order to proceed.

Current status and gap analysis
Device classification assessment
Documentation plan
Paperipankki application(opens in a new tab)
Kupipankki application(opens in a new tab)
Customer executes documentation

MDR Documentation

MDR + ISO 13485

For manufacturers who need a certification-ready quality management system in addition to documentation.

MDR documentation package
ISO 13485 quality management system
Annual internal audit
Certification audit support
Ongoing maintenance and updates

* Prices exclude VAT 25.5%

Service Contents

Gap Analysis

Service Contents

Current status and gap analysis: Yes
Device classification assessment: Yes
Documentation plan: Yes
Paperipankki application(opens in a new tab): Yes
Kupipankki application(opens in a new tab): Yes
Technical documentation: No
Clinical evaluation (CER): No
Risk management according to ISO 14971: No
PMS and PMCF plans: No
Labeling and instructions for use: No
EU declaration of conformity: No
ISO 13485 quality management system: No
Documentation implementation: Customer self
Internal audit: No
Notified body support: No
Annual obligations (PSUR, CER updates): As an additional service
Flexible extension: Easy upgrade to MDR documentation package

MDR Documentation

Service Contents

Current status and gap analysis: Yes
Device classification assessment: Yes
Documentation plan: Yes
Paperipankki application(opens in a new tab): Yes
Kupipankki application(opens in a new tab): Yes
Technical documentation: Yes
Clinical evaluation (CER): Yes
Risk management according to ISO 14971: Yes
PMS and PMCF plans: Yes
Labeling and instructions for use: Yes
EU declaration of conformity: Yes
ISO 13485 quality management system: No
Documentation implementation: MDRpankki implements
Internal audit: No
Notified body support: Clarification requests
Annual obligations (PSUR, CER updates): As an additional service
Flexible extension: –

MDR + ISO 13485

Service Contents

Current status and gap analysis: Yes
Device classification assessment: Yes
Documentation plan: Yes
Paperipankki application(opens in a new tab): Yes
Kupipankki application(opens in a new tab): Yes
Technical documentation: Yes
Clinical evaluation (CER): Yes
Risk management according to ISO 14971: Yes
PMS and PMCF plans: Yes
Labeling and instructions for use: Yes
EU declaration of conformity: Yes
ISO 13485 quality management system: Yes
Documentation implementation: MDRpankki implements
Internal audit: Annually
Notified body support: Complete certification process
Annual obligations (PSUR, CER updates): As an additional service
Flexible extension: –

Service Contents

Feature
Current status and gap analysis	Yes	Yes	Yes
Device classification assessment	Yes	Yes	Yes
Documentation plan	Yes	Yes	Yes
Paperipankki application(opens in a new tab)	Yes	Yes	Yes
Kupipankki application(opens in a new tab)	Yes	Yes	Yes
Technical documentation	No	Yes	Yes
Clinical evaluation (CER)	No	Yes	Yes
Risk management according to ISO 14971	No	Yes	Yes
PMS and PMCF plans	No	Yes	Yes
Labeling and instructions for use	No	Yes	Yes
EU declaration of conformity	No	Yes	Yes
ISO 13485 quality management system	No	No	Yes
Documentation implementation	Customer self	MDRpankki implements	MDRpankki implements
Internal audit	No	No	Annually
Notified body support	No	Clarification requests	Complete certification process
Annual obligations (PSUR, CER updates)	As an additional service	As an additional service	As an additional service
Flexible extension	Easy upgrade to MDR documentation package	–	–

Detailed Package Descriptions

Below are detailed descriptions of MDRpankki service packages. You can start with a gap analysis, order the complete documentation done for you, or also include a quality management system.

Gap Analysis – clear picture of MDR requirements

The gap analysis is designed for manufacturers who want to know their current status precisely before bigger decisions. We review the device’s intended use, classification, existing materials, and identify what MDR compliance still requires.

With the gap analysis, you get:

Assessment of device intended use and classification
Gap analysis of current documentation against MDR requirements
Prioritized documentation plan
Estimate of timeline and workload
Paperipankki application(opens in a new tab)
Kupipankki application(opens in a new tab)
Option to later upgrade to MDR documentation package with gap analysis credited

Gap analysis is the best option when you want certainty about the current state and decide on the implementation method afterward.

MDR Documentation – ready and audit-ready materials

MDR documentation package suits manufacturers who want technical documentation and clinical evaluation fully prepared. We handle the entire package so that the documents align and stand up to notified body review.

The package includes:

All contents of the gap analysis package
Technical documentation according to MDR Annexes II and III
GSPR compliance matrix with justifications
Clinical evaluation from plan to report (CEP, literature search, CER)
Risk management materials according to ISO 14971
Post-market surveillance plans (PMS and PMCF)
Labeling and instructions complying with target market requirements
Finalizing the EU declaration of conformity
Support in responding to notified body clarification requests

We deliver the first version of the documentation at a fixed price. Recurring obligations are agreed separately – see Ongoing Obligations below.

MDR + ISO 13485 – documentation and quality management system

The most comprehensive option for manufacturers whose notified body requires a certified quality management system. In addition to MDR documentation, we build the ISO 13485 system and support you through certification.

The package includes:

Complete contents of the MDR documentation package
Building the ISO 13485 quality management system
Processes, responsibilities, and procedures tailored to your company
Annual internal audit and management review
Support throughout the certification audit
Ongoing maintenance, updates, and change control

This comprehensive package suits manufacturers wanting both documentation and system in order with a single partner.

Ongoing obligations – what happens after delivery

MDR documentation is not a one-time task. Some materials must be updated regularly throughout the device lifecycle by law, regardless of the package you purchased. Packages cover the initial documentation – recurring obligations are agreed separately.

PSUR – periodic safety update report: Required at least every two years for class IIa devices, annually for classes IIb and III. For class I devices, this obligation is fulfilled via the PMS report.
Clinical evaluation update: Updated based on accumulated post-market data. For class III and implantable devices at least annually, for others typically every two to five years.
Handling post-market data: Collected feedback, incidents, and PMCF results must be assessed and fed back into risk management and clinical evaluation. The assessment checks what actions have been taken on the gathered information.

You can handle these yourself based on plans we draft, or order them from us as an annual service on top of any package. We agree scope and pricing based on device risk class.

Inquire about annual service