Medical Devices

Chemsafe provides strategic MDR/IVDR consultancy to support CE-mark compliance across Europe, including device classification, technical documentation, and alignment with post-market surveillance (PMS) requirements.
Our approach ensures evidence-based claims, mechanism-of-action demonstration, and comprehensive literature review.
We proactively address stricter pre-market evidence standards, updated risk classifications, and newly defined product groups without a medical purpose, accelerating time-to-market while maintaining regulatory state of the art requirements.

Our feasibility studies provide early-stage regulatory insight to streamline your path to market. We help you:
• Determine the right regulatory framework for your product, including MDR/IVDR and borderline cases.
• Review claims, intended use, and indications to ensure compliance.
• Confirm accurate device classification and submission requirements.
• Build a tailored regulatory strategy for EU, US, and international markets.
• Map essential certification steps and testing needs.

By managing borderline and non-standard products with expertise, we simplify your regulatory journey—reducing costs, avoiding rework, and accelerating time-to-market.

Identification of the necessary steps to certify a new product, including individuation of the required tests.

Regulatory Gap Analysis

Stay compliant with the latest ISO standards and regulatory guidelines. Our Regulatory Gap Analysis identifies changes that affect your devices, verifies whether existing tests remain valid, and highlights what needs to be updated. This ensures compliance, reduces unnecessary costs, and simplifies your path to MDR/IVDR conformity.

MDD to MDR Gap Analysis

Transition from MDD to MDR with confidence. We review your technical files to identify missing elements, assess risks, and provide actionable recommendations. Our roadmap for MDR compliance helps you prioritize tasks, avoid delays, and maintain a predictable, efficient regulatory strategy.

Pharmacological Activity Assessment

Chemsafe provides expert reports evaluating and excluding pharmacological activity for substance-based medical devices under MDR requirements. Our analysis covers pharmacological action, claim exclusion, and potential ingredient activity.

Toxicological & ADME Profile

We prepare toxicological and ADME (Absorption, Distribution, Metabolism, Elimination) profiles for all functional and non-functional ingredients, verifying systemic exposure and pharmacokinetics to confirm safety. Reports justify the absence of additional studies when supported by threshold-based evidence,following the approach suggested by ISO 10993-17:2023. Formulations are assessed for safety based on intended use and exposure.

All reports are reviewed and signed by our European Registered Toxicologist (ERT), providing compliant and defensible documentation.
All our pharmacological reports are verified and signed by an expert pharmacologist.

The evaluation of obtained results from chemical characterization studies is a key element of the biological evaluation of a medical device, according to ISO 10993 series.
In particular, ISO 10993-17:2023 defines the approach for assessing the toxicological safety of potentially released chemicals, based on patient exposure and scientifically safety limits.

Chemsafe performs toxicological assessments in accordance with ISO 10993-17:2023 and applicable ICH guidelines, supporting the interpretation of chemical characterization and Extractables & Leachables (E&L) data and the characterization of associated biological risk.

The service includes:
•Critical analysis of chemical characterization and E&L data
•Identification of substances relevant for toxicological assessment
•Assessment of systemic exposure based on the intended use of the device
•Definition of health-based exposure limits and risk characterization
•Application of threshold-based approaches (e.g., TTC, where appropriate)
•Evaluation of relevant toxicological endpoints, including subchronic and chronic effects, based on exposure duration

All documentation is reviewed and signed by our European Registered Toxicologists (ERT) and forms an essential component of the Biological Evaluation Report (BER), providing a robust, compliant, and scientifically defensible toxicological profile to support access to target markets.

Biological Evaluation is a fundamental component of your risk-management process, providing a comprehensive biocompatibility assessment based on the individual constituents and intended use of your device. This evaluation addresses multiple biological hazards and supports a robust risk characterization aligned with international regulatory expectations.

BEP – Biological Evaluation Plan:

The process begins with the assessment of available physicochemical characterization data of materials, including materials derived from the manufacturing process , followed by the identification of biological endpoints to be addressed (biocompatibility tests and chemical characterization test strategy) according to the duration and nature of body contact.
A thorough assessment of existing data, including literature, material specifications, and manufacturing information, is essential to determine residual biological risks and define strategies to mitigate them.

BER – Biological Evaluation Report:

The BER consolidates the results of all chemical and biocompatibility tests, the Toxicological Risk Assessment, and all supporting evidence needed to demonstrate the biological safety of your device. This structured evaluation identifies biological hazards, justifies risk-control measures, and ensures your device meets biocompatibility requirements across different international markets and regulatory geographies.

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.

Chemsafe relies on a consolidated network of specialized partners, both in Italy and internationally. These partners have been rigorously selected based on their technical excellence and domain-specific expertise. Our service model is structured by service line, with each area supported by best-in-class providers, ensuring the highest standards of quality and performance. This approach allows us to deliver advanced, reliable, and scalable solutions, leveraging the strengths of leading players in each field.

By integrating external centers of excellence into our operational framework, we combine strategic oversight with specialized execution providing our clients with a “360° stress free solution”.

Chemsafe provides risk-based, tailored solutions, guiding the collection and evaluation of clinical evidence to ensure CEP updates, MDR Annex XIV compliance, and smooth regulatory submissions, helping you demonstrate safety and performance while accelerating approvals.

We follow a structured 5-stage approach to guide your clinical evaluation, starting from:

Planning & Identification
• Define scope, objectives, and intended use.
• Establish study design and data collection methods.
• Organize clinical evidence and assess risks.
• Conduct a literature review.
• Plan PMS and real-world data collection.

And then moving on Report Preparation & Update

• Review risk classification and technology novelty.
• Document performance claims and benefits.
• Compare with existing CE devices or manage new submissions.
• Update the CER for design or use changes.
• Summarize real-world data supporting safety and performance.
• Ensuring the safety and performance of medical devices in real-world settings has never been more critical

Chemsafe helps ensure your device meets MDR/IVDR requirements by preparing or reviewing Technical Documentation.
• Preparation: develop compliant documentation based on Annex II (Technical Documentation) and Annex III (Post-Market Surveillance).
• Review & Updates: keep documentation current with regulatory changes and support post-market surveillance.
With the manufacturer’s information, Chemsafe ensures your Technical Documentation is complete, compliant, and audit-ready.

Ensuring compliance with international standards has never been easier. We provide comprehensive support for medical device and IVD manufacturers to implement and maintain a Quality Management System (QMS) fully compliant with ISO 13485, across the entire product lifecycle – audit-ready, risk-free, and tailored to your business.

Our services include:

• Tailored Implementation: build up a QMS that meets the unique needs of your organization.
• Ongoing updates: keep your system fully aligned with the latest regulations and guidelines.
• Full product lifecycle support: from design and development to production, distribution, and post-market activities.
• Risk reduction & Audit-Ready: preparing your company for inspections and audits with confidence.

With our support, you can focus on your core business while we ensure quality, safety, and compliance every step of the way.

We help medical device companies streamline their interactions with regulatory authorities across Europe and globally.

We connect you directly with the right regulatory authorities, manage all communications, and keep you ahead of evolving EU and global regulations.

Our service ensures you stay compliant, proactive, and ready for market, while minimizing risk and administrative burden.

Chemsafe can formally fill in the role of external Person Responsible for Regulatory Compliance (PRRC), ensuring continuous availability, appropriate competence, and full traceability, in accordance with Article 15 of the MDR and IVDR.

By outsourcing the PRRC function, you benefit from a structured, compliant, and reliable regulatory oversight, while reducing internal regulatory burden and operational complexity.

PRRC main responsibilities:
• Verifies device conformity and regulatory documentation before market release.
• Oversees PMS and vigilance activities and ensures timely reporting to Authorities.
• Manages CE marking documentation, labeling, and UDI compliance, keeping files audit-ready.
• Serves as your regulatory interface with Notified Bodies and Competent Authorities, supporting audits and inspections.
• Integrates regulatory compliance into your ISO 13485 QMS and provides strategic guidance throughout the product lifecycle.

Why Outsource the PRRC Role to Chemsafe:
• Formal appointment of an independent and qualified PRRC
• Continuous availability as required by MDR/IVDR
• Clear definition of roles and responsibilities
• Reduced internal regulatory workload
• Experienced regulatory interface with Authorities and Notified Bodies

Are you a medical device manufacturer based outside the EU?

To sell your products in Europe, appointing an EU Authorised Representative (AR) is not optional, it is a legal requirement under the EU Medical Device Regulation (MDR 2017/745).

Chemsafe act as your trusted EU Authorised Representative.
We provide a reliable, compliant, and business-focused AR service, ensuring your devices meet MDR requirements and remain on the EU market without disruption.

AR main responsibilities:
• Validate compliance: check your DoC and technical file for MDR readiness
• Represent you in the EU: official contact with Authorities and Notified Bodies
• Stay inspection-ready: your documentation always available on request
• Protect your market access
• Label correctly