Pricing

MDRpankki service packages

We offer three clear ways to progress towards MDR compliance. You can start with a light-touch assessment of your current situation, order complete MDR documentation and an ISO 13485 quality management system as a turnkey service, or purchase expert support by the hour exactly where you need it. Packages are priced at a fixed rate according to the device class and scope - consulting is charged based on actual hours worked.

Assessment

The best option when you want to know exactly what is missing and in what order to proceed.

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Assessment of the current situation and gaps
Device classification assessment
Documentation plan
Paperipankki application(opens in a new tab)
Kupipankki application(opens in a new tab)
Customer implements the documentation

MDR documentation

Tailored consulting

Suitable for manufacturers whose documentation is already partly in order and who only need expert support in a specific area.

Hourly rate

Individual documents and reviews
Support for clinical evaluation and risk management
Responses to requests for additional information
Quality management system maintenance and audits
Training and coaching
Charged based on actual hours worked

* Prices exclude 25.5% VAT

Service content

Assessment

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Service content

Assessment of the current situation and gaps: 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 in accordance with ISO 14971: No
PMS and PMCF plans: No
Labelling and instructions for use: No
EU declaration of conformity: No
ISO 13485 quality management system: No
Internal audit: No
Notified body support: No
Documentation implementation: By the customer
Annual obligations (PSUR, CER update): Available as an additional service
Pricing: Fixed price
Flexible expansion: Easy to move to the MDR documentation package

MDR documentation

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Service content

Assessment of the current situation and gaps: 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 in accordance with ISO 14971: Yes
PMS and PMCF plans: Yes
Labelling and instructions for use: Yes
EU declaration of conformity: Yes
ISO 13485 quality management system: Yes
Internal audit: Annually
Notified body support: The complete certification process
Documentation implementation: Implemented by MDRpankki
Annual obligations (PSUR, CER update): Available as an additional service
Pricing: Fixed price
Flexible expansion: –

Tailored consulting

Hourly rate

Service content

Assessment of the current situation and gaps: As needed
Device classification assessment: As needed
Documentation plan: As needed
Paperipankki application(opens in a new tab): No
Kupipankki application(opens in a new tab): No
Technical documentation: As needed
Clinical evaluation (CER): As needed
Risk management in accordance with ISO 14971: As needed
PMS and PMCF plans: As needed
Labelling and instructions for use: As needed
EU declaration of conformity: As needed
ISO 13485 quality management system: As needed
Internal audit: As needed
Notified body support: As needed
Documentation implementation: According to the agreed scope
Annual obligations (PSUR, CER update): As needed
Pricing: Hourly rate
Flexible expansion: –

Service content

Feature
Assessment of the current situation and gaps	Yes	Yes	As needed
Device classification assessment	Yes	Yes	As needed
Documentation plan	Yes	Yes	As needed
Paperipankki application(opens in a new tab)	Yes	Yes	No
Kupipankki application(opens in a new tab)	Yes	Yes	No
Technical documentation	No	Yes	As needed
Clinical evaluation (CER)	No	Yes	As needed
Risk management in accordance with ISO 14971	No	Yes	As needed
PMS and PMCF plans	No	Yes	As needed
Labelling and instructions for use	No	Yes	As needed
EU declaration of conformity	No	Yes	As needed
ISO 13485 quality management system	No	Yes	As needed
Internal audit	No	Annually	As needed
Notified body support	No	The complete certification process	As needed
Documentation implementation	By the customer	Implemented by MDRpankki	According to the agreed scope
Annual obligations (PSUR, CER update)	Available as an additional service	Available as an additional service	As needed
Pricing	Fixed price	Fixed price	Hourly rate
Flexible expansion	Easy to move to the MDR documentation package	–	–

Detailed package descriptions

Below are detailed descriptions of MDRpankki service packages. You can start with an assessment, order the documentation and quality management system to be completed for you, or purchase expert support by the hour.

Assessment - a clear picture of what MDR requires from you

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The assessment is designed for manufacturers who want to know their current situation precisely before making bigger decisions. We review the device's intended purpose, classification and existing materials, and identify what is still required for MDR compliance.

With the assessment, you receive:

An assessment of the device's intended purpose and classification
A gap analysis of current documentation against MDR requirements
A prioritised documentation plan
An estimate of the schedule and workload
Paperipankki application(opens in a new tab)
Kupipankki application(opens in a new tab)
The option to move later to the MDR documentation package, with the assessment cost credited

The assessment is the best option when you want certainty about your current situation before deciding how to proceed.

MDR documentation - complete documentation and an ISO 13485 quality management system

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The MDR documentation package is suitable for manufacturers who want technical documentation, clinical evaluation and a quality management system built and ready to use. In practice, a notified body almost always requires a certifiable ISO 13485 system, so it is included in the package - the documentation and system are created at the same time and remain aligned.

The package includes:

The full content of the assessment package
Technical documentation in accordance with MDR Annexes II and III
A GSPR compliance matrix with justifications
Clinical evaluation from plan to report (CEP, literature search, CER)
Risk management documentation in accordance with ISO 14971
Post-market surveillance plans (PMS and PMCF)
Labelling and instructions for use in accordance with target market requirements
Finalisation of the EU declaration of conformity
Development of an ISO 13485 quality management system: processes, responsibilities and procedures tailored to your company
Annual internal audit and management review
Support throughout the certification audit and in responding to notified body requests for additional information

We deliver the first version of the documentation and quality management system at a fixed price. Recurring annual obligations are agreed separately - see Ongoing obligations below.

Tailored consulting - expert support by the hour

Hourly rate

Tailored consulting is suitable for manufacturers whose documentation and quality management system are already largely in order, or who need help only in a specific area. We do not sell a package but agreed work: together, we define the scope and schedule, and the work is charged based on actual hours worked.

Our consulting services can include:

Drafting or reviewing individual documents
Expert support for clinical evaluation and risk management
Responses to notified body requests for additional information
Maintenance of the ISO 13485 system, internal audits and management reviews
Change control and documentation updates
Training and coaching for your quality and product development team

We always provide an estimate of the workload before starting and can agree a maximum price if you want certainty about the total cost.

Ongoing obligations - what happens after delivery

MDR documentation is not a one-off task. By law, some materials must be updated regularly throughout the device life cycle, regardless of how the documentation was originally prepared. Our delivery covers the first version of the documentation - recurring obligations are agreed separately.

PSUR - periodic safety update report: Required at least every two years for Class IIa devices and annually for Class IIb and III devices. For Class I devices, the corresponding obligation is fulfilled through a PMS report.
Clinical evaluation update: The clinical evaluation is updated based on accumulated follow-up data. At least annually for Class III and implantable devices, and typically every two to five years for other devices.
Processing follow-up data: Collected feedback, incidents and PMCF results must be assessed and fed back into risk management and clinical evaluation. The assessment asks what has been done with the accumulated data.

You can manage these yourself based on the plans we prepare, order them from us as an annual service, or purchase the work as hourly consulting. We agree the scope and price according to the device risk class.

Ask about the annual service