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) 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:

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

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)	MDR (2017/745)
Process	Medical devices are classified according to the applicable rules	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 function) IIa IIb III	I I (sterile) I (measuring functionality) I (reusable surgical instruments) IIa IIb IIb (implant) IIb (active, administration of drugs) III III (implant)

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).

Medical Device Regulation MDR ready… set, go!