Medical devices


Consultancy MDR/IVDR (Regulation (EU) 2017/745) and Regulation (EU) 2017/746))

If you have any doubts regarding the regulation and the concerning guidelines/standards or how to implement them, our experts can help you.

Feasibility studies

Feasibility studies include:
A preliminary analysis of your product, does the MDR apply? If not, what regulation does (i.e. Borderline Products)?
The classification of your product, which classification rule applies?
Identifying the necessary steps to certify a new product, including individuation of the required tests.

Data gap analysis

The gap-analysis helps you to understand what kind of tests/analysis might be missing or need to be implemented (confronting old and recent versions of ISOs) to be compliant with the MDR requirements.

Pharmacological Evaluation Report

Based on the new MDR requirements for substance-based medical devices, Chemsafe can provide you with an expert report able to exclude any pharmacological action of your ingredients.
All our pharmacological reports are verified and signed by an expert pharmacologist.

Toxicological Evaluation Report

The toxicological evaluation is an important part of the Biological Evaluation Report, since it is a toxicological assessment of the individual chemical constituents used in the manufacturing process of your device. Mandatory for E&Ls (extractables and/or leachables) detected at levels of concern.
All our toxicological expert reports are verified and signed by our ERT (European Registered Toxicologist).

Biological Evaluation in compliance with ISO 10993-1

The Biological evaluation is a crucial part of your risk management. This assessment consists of a biocompatibility evaluation based on the individual constituents and use of your device. Multiple aspects need to be addressed to successfully mitigate the biological risk.

  • BEP (Biological Evaluation Plan): The first step is a chemical characterization, then, based on the duration and nature of body contact, the required tests for your device are identified. The evaluation of all existing research data available (literature, the manufacturing processes, material specifications etc) is crucial for identifying the remaining biological risk and how to address it.
  • BER (Biological Evaluation Report): This report contains all the results obtained from your tests (chemical, biocompatibility), your toxicological risk assessment and other pertinent information gathered to support the safety of your product.

Study Monitoring

While Chemsafe has no internal laboratory, we can assist you during the testing phase thanks to our vast and versatile network and partnerships.

Clinical evaluation

The clinical evaluation serves to produce, collect, analyse and evaluate clinical data relating to your device in order to verify its safety and performance, including clinical benefits.
Chemsafe can support you in drafting the clinical evaluation plan (CEP) and report (CER) for your medical device, our services include:

  • preparing a clinical development plan
  • scope definition
  • defining how your device positions among the existing diagnostic or therapeutic alternatives
  • identification of appropriate data sources (systematic literature search, clinical trials, etc) and an adequacy assessment of these sources
  • critical data analysis
  • update of your clinical evaluation through data collection from post market activities

Risk management in compliance with ISO 14971

The purpose of Risk Management is to identify, evaluate, analyse and mitigate the potential risk of your product throughout its lifecycle. Chemsafe can support you during this process by providing you with a plan, identifying the risks and helping you to mitigate them, to ensure a proper risk/benefit ratio for your device.

Preparations/review of Technical Documentation

Based on the information provided by the manufacturer and the preparation of the documents stated above (Annex II, III of MDR/IVDR), Chemsafe prepares your Technical Documentation.

Implementation of Quality Management System (ISO 13485)

It is an essential requirement of the MDR that the Manufacturer has an QMS in place, we can help you setting it up and evaluate how being compliant with other QMS might impact.

Contacts with Competent Authorities (EU and non-EU)

Chemsafe provides support in identifying the Notified Body to complete the compliance process of your device. We can further assist you by directly communicating with the selected notified body on your behalf.