Medical Devices

Regulatory requirements for medical devices

 
Medical devices are instruments, apparatus, devices, software, materials or other articles for use in diagnostic and/or therapeutic applications. However, medical devices must not have a pharmacological, immunological or metabolic effect. Medical devices must undergo a conformity assessment procedure in Europe. This conformity assessment procedure varies in complexity depending on the medical device class.

In the coming years, the requirements for medical devices and their manufacturers will be significantly tightened by the forthcoming new Medical Device Regulation of the European Union. These new requirements of the Medical Devices Directive 2017/745 represent an enormous challenge for many manufacturers.

DREHM Pharma can be a valuable partner for these challenges and make you fit for the new requirements.

What does DREHM Pharma offer for medical devices?

Technical Documentation

DREHM Pharma evaluates existing documentation according to currently valid guidelines and regulations or writes new documentation for conformity assessment procedures.

Delimitation issues

DREHM Pharma evaluates borderline products and prepares delimitation reports for your medical device.

Regulatory support

DREHM Pharma advises you on all regulatory issues concerning medical devices, the preparation of labelling and the release of advertising materials.

Vigilance

DREHM Pharma provides a vigilance system with all necessary structures and resources (including 24h availability) and offers recording of incidents and forwarding to manufacturers and / or authorities.

DREHM Pharma provides the position of the authorized person:

  • Qualified Person (QP – by upcoming regulation)
  • Contracting of the conformity assessment procedure
  • Contact person for the authorities
  • Post Market Clinical Follow-Up (PMCF) and Post Market Surveillance (PMS)
  • Implementation of field safety corrective actions (FSCA)

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We are happy to share our experience with you!