When it comes to the performance and safety of medical devices, the requirements vary depending on the nature of the device in question and intended purpose of use. Stipulations go far beyond the requirements regarding design and manufacturing. Manufacturers are also required to establish, implement, document and maintain a risk management system. It is obligatory that any risks that may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. Furthermore, it is necessary to reduce risks as far as possible without adversely affecting the benefit-risk ratio.
Risk management standards
The risk assessment procedure is defined by ISO 14971, whereby risk management is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating. The requirements defined in ISO 14971 are quite complex. Formal questions often arise during a risk assessment when performed by medical and technical experts.
Risk assessment implementation and moderation
Our offer – your benefit
SCC offers to implement risk management in line with ISO 14971 in your quality management system and moderates risk assessments of your medical devices. With our expertise at your disposal, you will benefit from:
- Setting up procedures that are in line with all national and European requirements and have a broad international acceptance
- Enhancing cost and time efficiency of the assessment process
- Obtaining valuable information enabling you to develop medical devices perfectly fitting users’ and patients’ requirements
Contact our experts if you have questions with respect to risk analysis while you are planning to develop medical devices, preparing to place them on the market or considering a risk assessment update.
The medical device regulation MDR (EU) 2017/745
The new European Medical Device Regulation MDR (EU) 2017/745 came into force on 25 May 2017. It replaces the two European Directives 93/42/EEC and 90/385/EEC. Due to the postponement of the implementation deadlines as decided by the EU Parliament on 17 April 2020, the new MDR (EU) 2017/745 must now – apart from a few exceptions – be fully implemented by 26 May 2021.
New requirements and regulations for medical devices:
- Common European law, binding for all EU member countries
- More precise specifications for planning clinical evaluations
- Tightening of the requirements for the quality of clinical data, equivalence discussions and waiving clinical investigations
- Detailed regulation for the approval of clinical investigations
- Tightening of regulations governing post market surveillance and vigilance
- New classification rules for material-based medical devices, additional rules for products with nanomaterials and software
- Introduction of a consultation procedure involving an expert panel for specific class IIb and class III devices
- 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)
- Manufacturers are obliged to nominate a responsible qualified person
We help you comply with the requirements of MDR (EU) 2017/745
As service provider, SCC pilots you through the new regulation, ensuring smooth implementation:
- We offer training in which you learn how to implement the MDR in your company, helping you adopt the required procedures in line with ISO 13485.
- In close collaboration with you, we perform a gap analysis and develop individual concepts aimed at re-establishing conformity.
- With respect to the limited experience and uncertainty concerning the interpretation of the changes included in the MDR, we – as an independent party – clarify your open issues and negotiate acceptable solutions with notified bodies and authorities. Together with you, we develop an implementation strategy best fitted to your needs.
- We will also advise you on what the postponement by the EU Parliament of 17 April 2020 means for the implementation strategy in your company.
Get informed directly by our experts how to adopt the MDR requirements to your company with a minimum of effort.
Conformity assessments of medical devices
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.
Our experts assist you with clinical evaluations
SCC conducts scientific literature searches in line with the latest MEDDEV guidance 2.7/1 revision 4, Annex A4 and A5, which forms the basis for preparing and updating clinical evaluations. In terms of clinical evaluations, we offer specific services designed to meet the individual needs of our customers by either providing support during the evaluation process or preparing a clinical evaluation report or its update.
- Equipped with recent and individually customized literature, you can get an idea of your device’s ranking on the global market and the key factors relevant for the medical practice.
- Our up-to-date clinical evaluation helps you to save time and speed up the conformity assessment procedure with your notified body.
- With literature evidence prepared by our experts, you can save costs by avoiding unnecessary clinical investigations or PMCF studies.
Our expert service
Feel free to contact us for more information on the procedure of a clinical evaluation or request a call from our expert.
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.
Internationally oriented market strategies for medical devices
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 broad international acceptance.
- 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.
Safety and cost efficiency
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 with our portfolio of services:
- 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 up-to-date, giving them necessary insights to ensure compliance 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
Your benefit: SCC experts facilitate your access to new markets
Take advantage of our experience for a cost-efficient market launch in your target countries. Get in touch with our experts for international approvals now.
Medical devices – Biocompatibility
The biological evaluation (or biocompatibility test) of your medical device is a mandatory part of the conformity assessment.
Biological Evaluation of medical devices by ISO 10993
Evaluations carried out to determine the biological risks of medical devices are defined in ISO 10993 and product-specific standards, whereas the selection of applicable tests is device-dependent.
Biocompatibility assessment process – trust our expertise in biological evaluation
We assist with the categorisation of your medical devices and analyse physical as well as chemical information in detail, in order to evaluate further steps in a risk analysis following the current ISO 10993-1:2018. If there is no precise chemical information available, we will discuss the execution of chemical characterisations according to the current ISO 10993-18:2020 with you.
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 collaborate either with external contract partners or your laboratory during the design- test- and reporting phases.
Based on the results, SCC performs a risk assessment using toxicological literature and database data. In many cases, sufficient data is already available and no or just a limited number of biological tests are required.
In case further studies are required for the biological evaluation, we prepare the test plan together with the testing laboratory. We check all-round compliance with regulatory and scientific requirements and standards including the ISO 10993 (monitoring).
After completion of the studies, we prepare a final report as part of the conformity assessment procedure. In addition to the summary, discussion and evaluation of all results, the report also contains a detailed justification for waiving unnecessary tests.
- Evaluation of physical and chemical information (considering ISO 10993-18)
- Risk assessment in line with ISO 10933-1
- If required, preparation of study design together with the lab
- If required, study monitoring of biological tests
- Preparation of final report
- With good knowledge of the impact of various substances, we carefully select the tests to be performed. This strategy not only helps to save time and costs, but also avoid unnecessary animal testing.
- As early as the development phase, we can draw important conclusions based on cost-effective pre-evaluations, which help you prevent aberrations.
- We have been working with numerous national and international testing laboratories and know which ones can best meet your needs.
- In many cases, risk analysis can be supported by computer simulations. Rely on the expertise of our regulatory science team, helping you to draw the precise conclusions you need for your risk assessment by applying commonly available data combined with suitable models.
Don’t hesitate to contact us directly if you would like to learn more about our services for the biological evaluation of your medical devices.