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) 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
- Definition of the medical purpose
- Completion of classification
- Performance of a risk analysis pursuant to ISO 14971, based on the manufacturing process
- Verification of fulfillment of fundamental safety and performance requirements
- Preparation of technical documentation (including the completion of clinical evaluations)
- Completion of conformity assessment procedures
- CE labeling
- 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:
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
- Standard validation documents
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
- Customized validation documents (premium)
- Joint risk assessment
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:
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:
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.
- 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.
- Government officials will strictly monitor the process, an action that will lead to increased documentation activities.
- 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.
- There are NO exceptions: All certified medical devices must be re-certified.
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).