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Solutions Compliant
Medical Device Regulation

Wenzler MDR-Solutions

Expand Your (Custom) Product Portfolio Comfortably

The production of surgical instruments poses many challenges and advancements which require us to constantly adapt and improve.

The regulatory changes brought about by the introduction of the Medical Device Regulation in the European Economic Area have led to the implementation of new customers solutions. The solutions are of interest to all of our clients who have worked as manufacturers under the former MDD guidelines, have distributed surgical instruments under their brand name, and have ceded regulatory requirements, such as the Conformity Assessment Procedure, to their sppliers in an “OEM-PLM” configuration.

In order to continue to provide comparative opportunities to present your product portfolio, Raimund Wenzler offers several options, which are already utilized successfully by many of our clients.

You can view these options in detail in our MDR video.

Wenzler MDR-Solutions

Production, Retail, or Development. We Provide Your Solutions.

Option 1

You as MDR-compliant manufacturer of RW Standard Instruments or RWS Individual Instruments

Option 2

You as a retailer of products already authorised according to Art. 14 MDR, regulated by the QSV-distribution agreement.

Contract Manufacturing

Us as contract manufacturer for your innovations, with or without preexisting construction

Examples from Experience

Clients with a focus on the production of implants usually use OPTION2 as OBL (Own Brand Labelling) solution to expand their portfolio with instruments that allow surgically invasive access to the spine. Here, we offer an extensive premium product portfolio, including but not limited to our patented Open Up® system.

Retail businesses with a sole focus on sales and distribution use OPTION 2 to be able to distribute the high end-label Raimund Wenzler and expand their range of products.

Clients operating as manufacturer under MDR execute their own successful Conformity Assessment Procedure licensing using our basic documentation-package as part of OPTION 1. In doing so, they are completely independent in the distribution of their products.


You as MDR-Compliant Manufacturer

Option 1A

Choosing the first option, you perform as manufacturer and can offer product under your own brand name. We provide the optimal foundation for your own Conformity Assessment Procedure, possible for the complete RW Standard portfolio.

Stipulated in a correspondent quality assurance agreement (QSV), you as our client are the legal manufacturer and can conduct the Conformity Assessment Procedure. In this case, Raimund Wenzler GmbH as contract manufacturer is not displayed on your surgical instruments.

Your Benefits:

The products in our RW Standard portfolio have been implemented successfully in terms of production technology. Therefore, time- and cost-intensive construction- and Conformity Assessment Procedure can be omitted. As part of our Make to Order-strategy (MTO) a variety of product is available to order immediately.

Our technical basic documentation-package for your Conformity Assessment Procedure includes:

  • drawing of the final product
  • material information for the components
  • process-workflows in accordance with contact materials
  • process validation reports for the manufacturing process

Additionally, various production certificates for the final LOT/batch can be included.

You receive the perfect foundation to operate as legal manufacturer of your medical products. We are happy to provide further information at your request

Option 1B (contract manufacturing)

If our RW Standard range does not include a suitable product for you, we are sure to provide a fitting solution. You can commission individualized products based on our RW Standard line.

Your Benefits:

Construction / modification is carried out to your specifications while the realization in terms of production technology based on our basic components is quickly available. As final result of the manufacturing process you will be receive a fully individualized product.

Construction is necessary only once. The subsequent implementation of our Make to Order-strategy will then make your individual product available promptly.

You have the choice between:

  • various dimensions
  • modified jaw parts
  • diverse coatings
  • varying functional features

You will be provided with all relevant technological documents for production which can be used as a basis for your Conformity Assessment Procedure process.

Contact us to market successfully proved and tested products.

Your contact

Christian Wenzler


You as Retailer of CE Marking conform Products

Option 2A (OBL)

Your logo on the instrument. Legal manufacturer Raimund Wenzler, distributed by your company.

Distribute high end products with your logo. This option enables the expansion of your product range without extensive financial investments. This solution is referred to as Own Brand Labelling (OBL). According to MDR requirements, both companies are labeled here. This option serves as the development of earlier OEM-PLM relations as it is structured as a retailer-manufacturer-relationship under MDR.

The final surgical instrument will display your brand logo and the addition “distributed by …”. Therefore, you perform as distributer according to MDR Art. 14 as regulated by a  distribution agreement. In addition, our own emblem, with the addition “manufactured by Raimund Wenzler” is displayed as well. As legal manufacturer, we take care for the regulatory compliance.

Your Benefits:

The Raimund Wenzler company acts as legal manufacturer, eradicating any regulatory effort in terms of European distribution on your part as well as time- and cost intensive development and Conformity Assessment Procedure.

This distribution option is available for a selected product range and practicable without Own Brand Labelling (Option 2B).

Option 2B

Legal manufacturer Raimund Wenzler, distributed by your company.

With option 2B you receive retail ready Raimund Wenzler instruments. These surgical instruments are labelled and packaged according to regulations and can be distributed by you. This sales solution is the quickest way for you to distribute surgical instruments and expand your product range with the high end-label Raimund Wenzler easily and efficiently.


With this solution, you perform as distributer according to MDR Art. 14 as regulated by a distribution agreement. The Raimund Wenzler company acts as legal manufacturer, eliminating investments in regulatory product requirements for European distribution on your part. At the moment, this distribution option is available for a selected product range.

Contact us to become a distribution partner at the Raimund Wenzler instrument manufactory.

Your contact

Christian Wenzler