ISO 14971 – Risk Assessment of Medical Devices

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

SCC helps 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.

Substances of Concern and Nanomaterials

Substances of Concern

Medical devices are intended to improve health. Materials used for the production of medical devices, however, can contain – whether intended or not – substances or materials considered as nanomaterials or with the potential to cause adverse events, so-called substances of concern, such as carcinogenic, mutagenic and reprotoxic (CMR) substances or other critical materials.

In addition to specific regulations, medical devices produced or imported in the EU must also comply with the following regulatory requirements:

• REACH Regulation (EC) No 1907/2006 (Registration, Evaluation, Authorisation and Restriction of Chemicals)
• RoHS Directive 2011/65/EU (Restriction of Hazardous Substances in Electrical and Electronic Equipment)

With the growing political concern regarding the presence and use of endocrine disruptive substances (ED), on the one hand, and the lacking guidance how to evaluate their potential risks to human health and the environment, on the other, professional advice is becoming more important than ever. We can help you overcome your challenges related to substances of concern.

Our Solutions for Substances of Concern

• Estimating the likely costs based on a data gap analysis, identifying missing studies and finding waiving opportunities through detailed and systematic database and literature searches
• Regular monitoring of your raw material inventory in relation to new findings and regulatory changes
• Developing tailor-made compliance strategies to meet your needs
• Generating in silico data and performing knowledge- and statistics-based QSAR models to predict the activity, properties and toxicity of new or incomplete characterised substances based on the knowledge of their chemical structure
• Planning, contracting and monitoring of laboratory studies
• Applycation of EU guidelines on the benefit-risk assessment of the presence of phthalates
• Establishing allowable limits for leachable substances in accordance with ISO 10993-17 by our experienced toxicologists
• Dealing with specific requests to expert panels and competent authorities

Nanomaterials

Based on the new classification rule 19 in the EU Medical Device Regulation 2017/745, many medical devices need to be classified in higher risk classes if they contain nanomaterials. This is a complex task, especially because the current EU definition leads to ambiguity during testing when determining if medical devices contain or consist of nanoparticles. In addition, the potential for internal exposure is not clearly defined within the MDR, leading to additional uncertainty.

If nanomaterials are present, biological testing should be performed in line with the recent technical report ISO/TR 10993-22, published in 2017. With many labs having difficulties with implementing new test methods and several methods being defined within other ISO 10993 standards, nanomaterial testing remains nontrivial.

 Our Services for Nanomaterials

• Characterisation of nanomaterials according to the latest standards and guidelines
• Application of the nanomaterial definition and preparation of assessments to avoid higher classifications and additional tests
• Professional handling of questions regarding internal exposure
• Preparation of literature-based internal exposure assessments for your specific borderline products
• Assistance with selecting biological tests and monitoring services to handle the specific complexity of the test execution

Whatever your specific needs, SCC helps to ensure your medical devices are fit for the future.

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

Our Services

We help you comply with the requirements of MDR (EU) 2017/745 and pilot 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.

Regulation of Medical Devices

Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC is the trusted partner for the regulatory compliance of your medical devices, offering you expert advice tailored to your specific needs and helping you prepare the required approval documents. We pave the way to your market success.

Our Services

We offer the medical device industry regulatory and strategic solutions specialising in:

• International market access strategies
• Globally compliant quality management systems
• MDR (EU) 2017/745 compliance services
• Risk management in accordance with ISO 14971
• Biological evaluation in line with ISO 10993
• Expert advice on dealing with critical substances
• Clinical evaluation and literature research
• Qualification and validation

Learn the full range of our services in English or German and gain an impression of how we can guide you through the intricacies of medical device regulations and the related requirements.

Get to know our services in English			Get to know our services in German

Contact Our Experts

Together with you, we develop an implementation strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.

International Market Strategies for Medical Devices

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.

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.

SCC helps you ensure your medical devices are compliant with regulatory requirements in your targets markets. Learn more about our services and how we can assist you.

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

International Medical Device Markets 

We support our medical device customers in the following markets:

• Europe (EU member states including Turkey, UK and Switzerland)
• North America (USA, Canada)
• Latin America (Mexico, Columbia, Peru, Brazil, Chile, and Argentina)
• Asia (India, China and 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.

Regulation of Medical Devices

Medical device regulations are becoming increasingly complex, posing a real challenge to the whole medical device industry, particularly manufacturers, importers and distributors. SCC as a service provider has been monitoring the recent developments to offer you expert advice tailored to your needs and help you prepare the required approval documents. We support both, newcomers and established companies, paying special attention to the implementation of the relevant requirements, which we have outlined for you below.

Technical Documentation

A comprehensive technical documentation in accordance with the required country specific regulations and laws is the key to the intended market approval. SCC provides a broad spectrum of services, tailored to the specific needs of your products. We are your best choice if you plan and prepare your product for market approval: 

• We offer trainings and provide templates to assist you file your technical documentation.
• We provide comprehensive document creation services including evaluation plans, organisation of required tests and preparation of expert reports.
• We help you deal with nonconformities identified during an audit or documentation review.

MDR (EU) 2017/745

For the EU member states, the transition period for the implementation of the new medical device regulation MDR (EU) 2017/745 has expired in May 2021. Compliance with the new European regulation is a requirement for the CE marking and approval of your medical devices.

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.

Specific Requirements for Medical Device Approval

The detailed requirements for medical device approval are defined in numerous standards and guidelines:

Quality management systems in line with ISO 13485 and other standards

Quality management systems play an important role for manufacturers of medical devices. Our experts advise you on how to implement and optimise quality management systems and offer strategic, scientific and regulatory guidance on the implementation of quality-related processes, e.g. in R&D, production, and quality control.

Risk assessment of medical devices according to ISO 14971

One of the most important requirement with respect to safety and performance is the assessment of potential risks. Get informed how you can manage an internationally recognized risk management file with our help.

Biocompatibility of medical devices according to ISO 10993

All medical devices, which are intended to be in contact with the human body, need to be evaluated and tested within a risk management process according to ISO 10993-1. Find out how we can support you in the biological evaluation of your medical devices.

Substances of Concern and Nanoparticles

Materials containing substances with carcinogenic, mutagenic and reprotoxic (CMR) properties and nanomaterials are increasingly coming into focus. Learn how SCC can help you keep up with the latest developments in REACH, RoHS or other requirements.

Clinical evaluation of medical devices

For CE compliance in the European Union, you need to set forth clinical evidences for medical devices of all risk classes. Take advantage of our experience in literature research and the preparation of a clinical evaluation.

Qualification and validation

Verification, qualification and validation play an important role in development, manufacture and quality control. Find out what you need to consider.

International approval

Take advantage of the marketing opportunities in other regions and countries and, with our help, obtain international approval for your products.

Contact Our Experts

Together with you, we develop an implementation strategy best fitted to your needs. Learn how our experts can help you to adopt the MDR requirements to your company with a minimum of effort.

Clinical Evaluation of Medical Devices according to MDR (EU) 2017/745

Conformity Assessments of Medical Devices

In the EU, the technical documentation and clinical evaluation form the central part of medical device conformity assessments. A clinical evaluation is required for medical devices of all risk classes and is crucial in determining the need for clinical studies.

With the introduction of the new MDR (EU) 2017/745 and the recent MEDDEV 2.7/1 revision 4, the rules for planning and updating clinical evaluations have been tightened.

In 2020, the guidelines relating to clinical evaluation and the “clinical evaluation assessment report template” of the Medical Device Coordination Group (MDCG) were published. This means that all relevant guidance documents are now available for the preparation of a clinical evaluation in accordance with the MDR. However, the guidelines have now become increasingly complex and confusing, so that a clinical evaluation should definitely be carried out by experts in order to ensure conformity with all requirements.

Literature Research and Clinical Evaluations

Our experts conduct or update scientific literature searches in line with the requirements of the MDR (EU) 2017/745 under consideration of the latest guidelines, which form the basis for a clinical evaluation. In the case of newly developed products, we recommend to conduct a literature search in advance in order to be able to better assess the expected requirements and approval effort.

Our experts first create a clinical evaluation plan ensuring that all of the information we need for the report is available.

In terms of the clinical evaluation report, to provide the required information and evaluations in a targeted manner, we apply the "clinical evaluation assessment report template", which is also used by the notified bodies. Of course, if available, we also take into account the data of technically, biologically and clinically similar products in order to avoid gaps in the proof of suitability for the indications you have defined.

Your Benefits

• 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 expert clinical evaluation helps you to save time and speed up the conformity assessment procedure with your notified body.
• With suitable literature evidence and the professional evaluation of literature data, you can save costs by avoiding unnecessary clinical investigations or PMCF studies.

Feel free to contact us for more information on the procedure of a clinical evaluation or request a call from our expert. We also support you in processing deviations identified by your notified body.

Our Services for Medical Devices

We help you carry out conformity assessments, prepare your medical devices for a market launch, and keep your documentation up-to-date.

Contact our experts

They answer your questions and advise you on how you can make your medical devices fit for your target markets.

Fill out the form below or contact us by This email address is being protected from spambots. You need JavaScript enabled to view it. or phone (+49 671 298460).

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 according to 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. In the first half of 2021, the revised European EN ISO 10993-1:2020, based on ISO 10993-1:2018, was published as national EN ISO 10993-1:2021 standards. In light of this, several changes must be considered.

According to the introduction of the new standard, “it is not intended that this document provide a rigid set of test methods, including pass/fail criteria, as this might result in either an unnecessary constraint on the development and use of novel medical devices, or a false sense of security in the general use of medical device. … ISO 10993 series is intended for use by professionals, appropriately qualified by training and experience, who are able to interpret its requirements and judge the outcome of the evaluation for each medical device, taking into consideration all the factors relevant to the medical device, its intended use and the current knowledge of the medical device provided by review of the scientific literature and previous clinical experience.”

In line with Appendix B.2.2 (The biological evaluation plan) of ISO 10993-1:2018, risk management activities must be planned in advance. Since biological evaluation is a risk management activity, a biological evaluation plan is required. It is emphasized that simply planning to conduct testing against all of the aspects of biocompatibility identified in Annex A does not meet the requirements.

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.

Summary

• Evaluation of physical and chemical information (considering ISO 10993-18)
• Risk assessment in line with ISO 10993-1:2018
• If required, preparation of study design together with the lab
• If required, study monitoring of biological tests
• Preparation of final report

Your Benefits

• 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.

Qualification and Validation for Medical Devices

Alongside verification, qualification and validation are essential quality management tools for medical device manufacturers. However, their implementation tends to cause uncertainty, particularly among small producers. Questions frequently arise as to the exact circumstances in which these tools should be applied, and how the processes surrounding qualification and/or validation work in practice. Unlike the verification, the procedure of qualification and validation is more complex. In many cases, there is some uncertainty of how these methods are defined and can be distinguished.

Definitions and Distinctions

Verification

Verification is the documented proof that a product meets the specified requirements during development.

Qualification

Qualification is usually performed at facilities, instruments, production plants and QC labs, when they are relevant for the quality of the medical device. It is the documented proof, that the object to be qualified is suitable and safe for the intended use. A qualification consists of a DQ, IQ, OQ, and PQ:

• Qualification begins with the DQ (Design Qualification), which is performed before purchase to prove that all user requirement specifications are covered by the vendor’s system specifications.
• The IQ (Installation Qualification) proves that the delivery including all documents is complete and has been properly set up and connected.
• The OQ (Operational Qualification) is a testing procedure ensuring that every single function, including safety and alarm measures, operates properly.
• The PQ (Performance Qualification) is the final part of the qualification process, providing evidence, that the intended operation can be performed and reproduced within the specified limits for the complete area of operation.

Validation

Validation is the documented proof that the object to be validated performs in line with the required reliability during practical operating conditions. In the context of medical devices, validation applies to the following areas:

• A process validation is performed at the production plant and is necessary if not all potential risks are covered by the quality control.
• The method validation is required if non-standard methods are used for quality control.
• The medical device itself needs to undergo a design validation. This includes clinical evaluations, performance evaluations and usability tests.

Our Service: Your Individual Validation Plan

SCC can help you successfully integrate qualification and validation methods in your quality management system and identify equipment and processes subject to mandatory qualification or validation, or benefitting from validation activities for quality reasons or due to strategic considerations. We cooperate with production and quality management experts in your company to work out a customised validation plan meeting  your specific requirements. If required, we can advise you on how to implement your quality management system and help you prepare the relevant implementation documents.

Your Benefit

Our validation experts use their practical experience to apply the formal processes exactly where they have a positive impact on quality. Let our experts advise you.