• Regulatory Affairs
  • Combination products

Combination products

A particular challenge in EU approval is posed by products that contain both a medicinal product and a medical device component.

Such combination products are subject to both medicinal product and medical device regulations. The authorisation process is based on the component which has the primary effect:

  • Medical devices with an integral medicinal product component
  • Medicinal products with an integral medical device component

Medical devices with an integral medicinal product component fall under rule 14 of the MDR and must undergo a consultation process with the regulatory authorities for medicinal products. If medicinal products contain a medical device as an integral part (e.g. inhalers, single-use insulin pens), this medical device component must be assessed by a notified body prior to the authorisation of the medicinal product (Article 117 of the MDR).

You can benefit from our expertise in both areas. We provide full support to help you reach your targets and meet these complex requirements.

#combinationproducts

Our services:

 

  • Support on demarcation issues, classifications, compliance with requirements of the respective corresponding regulations
  • Consultation, preparation, evaluation of documentation and expert reports
  • Biological evaluations
  • Clinical evaluations
  • Experimental and analytical work for proof of conformity

 

 

  • Organisation of and support during consultations with authorities
  • Organisation of and support during pre-assessments with appointed bodies
  • Execution of the consultation or certification process
  • Preparation of position papers to classify borderline products

 

Contact us. We’re happy to help!

Dr. Andrea Klüting
Vigilance & Regulatory Affairs
Business Development HWI group

Phone: +49 89 2000203-60
Email:

Dr. Verena Peter
Quality/CMC

Phone: +49 89 2000203-71
Email:

Dr. med. Christian Schübel
Clinical Affairs/Medical Devices

Phone: +49 89 2000203-52
Email:

Hotline

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+49 7272 7767-0