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MDR Overview image 78 (HQ)

Medical Device Regulation

Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop

Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop

Summary

MDR Suite – A source of information for O&P Professionals

The aim of the new EU-wide and uniform regulations is to ensure patient safety and to enhance the quality of medical devices on the European market for the benefit of all. Manufacturers in particular are facing major challenges, as the implementation of the new requirements involves high effort and costs. The extent to which the changes arising from those regulatory replacement affects your business depends on the role you hold.

This website focuses on the new Medical Device Regulation 2017/745 (MDR) for manufacturers of custom-made devices. This new Medical Device Regulation 2017/745 (MDR) will play a significant role of patient care providers that create products like prosthetics, orthotics or wheelchairs. Creating prosthesis or orthosis is patient specific and therefore requires special documents which this website can help provide as information or as a template. This website will not take over your responsibility or liability, but we can offer support to be compliant to the Medical Device Regulation 2017/745 (MDR).

Relevant economic operators

For an overview of the different roles and responsibilities, the corresponding definitions, subcategories and further information are found here. The person responsible for regulatory compliance (PRRC) in particular is examined in detail.

Relevant economic operators

Appointment of the PRRC

The appointment of the PRRC must be made in writing. Depending on your role as economic operator, you can select the respective template for the appointment letter here.

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Letter of Appointment Authorised Representative Template-Rev01 EN-2 (HQ)

Letter of appointment for Authorised Representatives
Letter of appointment for Authorised Representatives
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Letter of Appointment Manufacturer Template Rev01 EN (HQ)

Letter of appointment for Manufacturers
Letter of appointment for Manufacturers
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Letter of Appointment Manufacturer custom-made devices Template Rev01 EN

Letter of appointment for Manufacturers of custom-made devices
Letter of appointment for Manufacturers of custom-made devices

3 Eredmények összesen: 3

Find out your role!

The prerequisite for implementing the MDR requirements is the correct understanding of the economic operators. It is therefore necessary that you can assign yourself and your patient care activities to one or more roles described by MDR. This decision tree will help you to do so. You need only answer a few questions to see the appropriate role or the economic operator to which you are assigned.

Find out your role_image (HQ)

Download the decision tree here!

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Decision tree Economic operators Rev01 EN (HQ)

1 Eredmények összesen: 1

Check compliancy

Are you already well prepared?

At some point you will reach the moment where you say:
"We have revised all necessary existing processes or even introduced new processes and are now well established."

In order to remove the last uncertainties you may still have, we provide you with a compliance checklist that you can use to check whether you have really thought of everything. It is easy for something, even a small detail, to be forgotten. And that would be very unfortunate, considering the work you and your team have put into implementing this project.

Select your role to find out the respective requirements

Download your compliance checklist here!

Here you find three lists that can be used for self assessment. Please note that if you are acting in the role of different economic operators, several checklists are relevant for you.

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646D1697-en Master-CheckList Distributor e (HQ)

Distributor
Distributor
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646D1699-en Master-Checklist Manufacturer (HQ)

Manufacturer
Manufacturer
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646D1698-en Master-Checklist Manufacturer of custom-made medical devices (HQ)

Manufacturer of custom-made medical devices
Manufacturer of custom-made medical devices

3 Eredmények összesen: 3

Requirement

Requirements towards patient care providers

When you fabricate and provide a custom-made device for a patient, you are a manufacturer of custom-made devices and must comply with the following requirements:

  • Draw up a statement according to Annex XIII for the custom-made device and Article 22 for the patient solution.

  • Mark devices as „custom-made device“.

  • Have a person responsible for regulatory compliance (PRRC).

  • Economic operators that devices were received from or supplied to must be identified.

In addition to that, you must implement the following processes:

  • Risk management

  • Clinical evaluation

  • Post-market surveillance (PMS)

  • Vigilance

Requirements

Risk Management

The risk management process requests the creation of a risk management file per patient solution group. The risk management system is a regulatory requirement.
The main aspect is to identify hazards with the products and to identify measures for risk control.
A risk management file consists of:
RM plan
Risk analysis and control
RM report

Documentation Effort

The documentation effort depends on the activity that is performed and thus on the role that you as a patient care provider currently hold. We have compared the documentation effort for three selected economic operators.

Manufacturer of serial-produced medical device

Manufacturer of custom-made medical device

System-Producer

Obligations for manufacturers of MD

Obligations for manufacturers of CMD

Documentation acc. Article 22 (2)

Documentation acc. Annex II & III

Documentation acc. Annex XIII Section 2

Statement acc. Article 22

Declarations of Conformity

Statement acc. Annex XIII

CE marking of conformity

Determine Basic UDI-DI

Register in EUDAMED

FAQ

Frequently Asked Questions

We take the questions of the affected patient care providers seriously and compile them here. Do you have any other questions that are bothering you?
Find the answer you are looking for here!

Glossary

The glossary provides definitions of the most important terms specified in the MDR. It is not necessary to look up terms in the legal text of the MDR – find the definitions and explanations you need here.

Contact

Compotent advice on MDR