Medical devices are subject to strict performance and safety requirements, leading to potentially high development costs. A broad market presence can help compensate for this high initial investment. One of the greatest challenges for the industry, however, is the diversity and complexity of regulatory systems in different countries. There are a number of legal aspects that manufacturers or importers need to be aware of to guarantee the regulatory compliance of their medical devices in target markets. We can work together with you to develop the best market entry strategy for your medical devices in your target markets:

For conformity assessments, we help you design your tests and studies to ensure acceptance in all of your target markets.

We maintain an overview of developments in potential markets for your medical devices to help you recognise potential regulatory hurdles in advance and get your products and documents fit for future challenges.

We develop strategies for cost-efficient market access for your medical devices.
Cultural and language barriers, combined with a lack of experience in dealing with national authorities in target countries, can make market entry a real challenge. But SCC can help you. Backed up by our international network of experienced partners, we pave the way for a smooth regulatory process in various fast-growing markets:
  • Communicating with national authorities in target countries on behalf of customers
  • Providing technical translation services
  • Staying on guard to protect customers’ sensitive data by ensuring that only registration-relevant information is shared with the respective authorities in target countries
  • Keeping our customers’ product portfolios up to date and compliant with the latest regulatory developments in target countries
We support our medical device customers in the following markets:
  • North America (USA, Canada)
  • Latin America (Mexico, Columbia, Peru, Brazil, Chile, Argentina)
  • Asia (India, China, Japan)
  • Australia, Oceania
  • Further countries on request
For further information, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

In the EU, the technical documentation and clinical evaluation form the central part of medical device conformity assessments in cases where clinical investigations are not required. With the introduction of the new MDR (EU) 2017/745, the rules for planning and updating clinical evaluations have been tightened.

SCC can search for and provide you with scientific literature in line with the latest MEDDEV guidance 2.7/1 revision 4, which forms the basis for preparing and updating clinical evaluations.

For clinical evaluations, SCC offers a broad range of services: We can support you during the process or – based on the data you provide – fully prepare or update the clinical evaluation for your medical devices.

Your challenge – our solution

The new European Medical Device Regulation (EU) 2017/745 came into force on 25 May 2017. It  replaces the two European Directives 93/42/EWG and 90/385/EWG. With some exceptions, the new regulation must be fully adopted by 26 May 2020.

The major changes are:

  • More precise specifications for planning clinical evaluations
  • Detailed regulation for the approval of clinical investigations
  • Tightening of regulations governing vigilance and market surveillance
  • New classification rules for material-based medical devices, additional rules for products with nanomaterials and software
  • New rules for the reprocessing of single-use devices
  • Introduction of the Unique Device Identification (UDI) system
  • Extension of the European database for medical devices (EUDAMED)
  • Requirement for manufacturers to provide sufficient financial coverage in respect of their potential liability

SCC can help you incorporate this new regulation into your company.

We can also help your R&D department with ISO 13485 procedure definitions and finding suitable funding programmes.

In addition to this, we have in-depth experience in the qualification and validation of your products as well as production and quality control equipment and methods.

Further, SCC offers international approval of medical devices, directly or in cooperation with our international partners.

Evaluations carried out to determine the biological risks of medical devices are defined in ISO 10993 and a number of other product-specific standards, whereas the selection of applicable tests is device dependent.

We design all necessary studies. If you do not have in-house capacity, we arrange to have them carried out at laboratories that are best suited to your needs. We provide support with risk assessments and help you select the right studies. We collaborate with external contract partners or your in-house laboratories during the testing and reporting phases (monitoring). We check all-round compliance with regulatory and scientific requirements and standards, and help you prepare the final report.

Biological evaluation is usually part of a conformity assessment, but it can also be done as a stand-alone project.