Medical Device Regulation

MDR ready… set, go!

With our help, you can easily

meet the requirements of the

Medical Device Regulation.

Get optimal help with the Medical Device Regulation

The big day has arrived: On May 26, 2021, the Medical Device Regulation (MDR) went into effect for Class I medical devices. Medical devices in other classes will gradually be placed under the MDR during a transition period. Increased protection of public health, additional transparency, improved traceability and greater patient safety: These are just a few of the objectives of the new EU regulation on medical devices. Preparing for the MDR is a complex task that we want to make as easy for you as possible. How do things look from your perspective? Are you ready for your MDR-compliant medical device with our expert help?

RAUMEDIC - Your partner for MDR matters

Your reliable partner for all aspects of the approval process

You will have to keep many things in mind during the approval process. We will help you prepare the relevant documents and can give expert answers to your questions. We will provide you with the best-possible support during the approval process. Profit from the knowledge we gained during the approval process of our own medical devices in all classes (Class I to III and active implantable medical devices) in the areas of neurosurgery and traumatology.

"Approval for medical devices is a fairly costly process. We can act as your support partner, set up contacts with testing labs, coordinate the required tests and prepare the necessary documents or help you prepare them."

Complete these eight
MDR steps with our help

01

Definition of
the medical purpose

02

Completion
of classification

03

Performance of a risk analysis
pursuant to ISO 14971,
based on the manufacturing process

04

Verification of fulfillment
of fundamental safety
and performance requirements

05

Preparation of technical documentation
(including the completion
of clinical evaluations)

06

Completion of
conformity assessment procedures

07

CE
labeling

08

Performance of
post-market surveillance

We will help you – on a completely individual basis

You will receive everything from a single source – including in terms of the MDR. As your approval-process partner, we will prepare complete and well-organized documentation for you. Select the service package that best suits your needs. Depending on the option you select, we will provide you with the documents you need for the MDR approval process.

Explore the range of documentation options here:

Standard Documentation

Material information package

  • Identification of materials being used
  • Material certificate with documentation about critical substances (e.g., CMR substances, nano-materials)

 

Technical delivery agreement

  • Product-specific features
  • Information about relevant norms
  • Design, dimensions, tolerances
  • Information about sterilization
  • Labeling

 

Process

  • Standard validation documents

Supplemental Documentation

This package comprises all of the information in the Standard Documentation along with:

Material information package

  • Biological analysis
  • Test reports
  • Individual and product-specific material data

 

Technical delivery agreement

  • Relevant additional information
  • Product-specific validation (e.g., transport, sterilization)
  • Product-related regulatory data

 

Process

  • Customized validation documents (premium)
  • Joint risk assessment

Comprehensive Documentation

This package comprises all of the information in the Standard Documentation and Supplemental Documentation along with:

Assistance from our Regulatory Affairs Team:

  • with the preparation of technical documentation
  • with the selection of the sterilization process and the performance of sterilization validation
  • with the selection of packaging/transport validation in terms of shelf life

Everything you need for fast MDR certification

Complete every step on your way to MDR approval with our expert assistance. Put your trust in more than 70 years of experience in medical technology and the pharmaceutical industry:

Individual provision of relevant documents
Document-management security
Compliance with VDI Standards issued by the Association of German Engineers (VDI 2017 “Medical grade plastics”)
High level of traceability and in-depth information regarding product development/processes/materials
Expert contact persons for questions – including those related to the disclosure of information
Verification of materials and components used
Reduced administrative costs

Frequently asked questions about the MDR

Do you a have question? No wonder! We have compiled a few answers here about the approval process and the new regulation (EU) 2017/745:

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Which specific products are covered by the MDR?

The MDR applies to all medical devices (products with a medical purpose) and accessories for human use. Medical devices are divided into four classes: I, IIa, IIb and III.

The classification according to MDD and MDR is shown below:

MDD (93/42/EEC)

Process

  • Medical devices are classified according to the applicable rules

 

Classification

  • I
  • I (sterile)
  • I (measuring function)
  • IIa
  • IIb
  • III

MDR (2017/745)

Process

  • Medical devices are classified according to the applicable rule
  • Classification guidelines have been partially changed
  • Differentiations within the same classes have been expanded

 

Classification

  • I
  • I (sterile)
  • I (measuring functionality)
  • I (reusable surgical instruments)
  • IIa
  • IIb
  • IIb (implant)
  • IIb (active, administration of drugs)
  • III
  • III (implant)

Will products used in the past no longer be available?

MDR certification is a costly process that could overwhelm some manufacturers. It is possible that devices used in the healthcare sector may suddenly no longer be available. Class I medical devices MUST comply with the MDR effective May 26, 2021. Medical devices in other classes will gradually become subject to the MDR during a transition period. We are well-prepared for the MDR and have a good understanding of the documents and key deadlines involved with it.

What are some of the main changes the MDR will make?

  1. Risk assessments of existing medical devices will be toughened: The products will be classified according to new criteria. Manufacturers are now required to review these new regulations and update technical documentation. The three criteria are: risk, length of contact and invasiveness.
  2. Government officials will strictly monitor the process, an action that will lead to increased documentation activities.
  3. The safety and performance profile of medical devices with a high risk classification (e.g. Class III and implantable devices) must be tested in clinical studies.
  4. There are NO exceptions: All certified medical devices must be re-certified.

What exactly is unique device identification (UDI)?

Unique device identification (UDI) is a system that is designed to clearly identify medical devices and in-vitro diagnostic devices. The product designation consists of two parts: the UDI-DI (device identifier) that is used to identify products and manufacturers and the UDI-PI (production identifier) that identifies the unit of the product (e.g. through the manufacturing date and unit number).

MDR … ready, set, go!
Get in touch with us now!

Do you want to have an expert with experience on your side?
If so, please contact us today.

We can assist you with the entire MDR process!

MDR Contact Form

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