Medical Device Safety & Regulatory Support

Biological Evaluation Plan (BEP) and Biological Evaluation Report (BER)

Our expert scientists offer BEP and BER drafting for medical devices according to ISO 14971, 10993 and MDR, which includes: 

• Gap analysis to the ISO standards; 

• Raw Materials/constituents Toxicological risk assessment (ISO 10993-17), including Margin of Safety derivation, and safety assessment, including local tolerability; 

• Assessment of Absorption, Distribution, Metabolism and Excretion (ADME) for MD’s ingredients; 

• Toxicological risk assessment of residual impurities from the manufacturing process (ISO 10993-17), degradation products (ISO 10993-13/14/15) and substances extracted and/or released by the primary packaging in the MD (ISO 10993-17) including polymers (plastic/silicon), solvents, elemental and genotoxic impurities and definition of their safety limits; 

• Application of Read-Across and Grouping approaches for data-poor substances for the purpose of filling the data gaps, in accordance with ECHA guidelines. 

• For substance-based medical devices that are intended to be introduced into the human body via a body orifice or applied to the skin, we perform a risk assessment on absorption, penetration and local distribution, as required by Rule 21 of Regulation (EU) 2017/745.  

Clinical evaluation

Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) 

Our expert scientists offer CEP and CER drafting for medical devices according to MDCG, MEDDEV and SSCP guidelines, which includes: 

• Conduction of in-depth literature research for clinical data, supporting the device’s claims, including their appraisal according to IMDRF MDCE WG/N55FINAL:2019 – Clinical evaluation; 

• Punctual description of Sponsor’s conducted clinical studies; 

• ToxHub collaborates with a network of medical professionals to obtain the necessary signatures for these documents. 

Biocompatibility Test Plan strategy

At ToxHub, we offer expert services for the biocompatibility assessment of medical devices: 

• Development of Biocompatibility Test Plans, following 3R principles to minimize animal testing and avoid inefficiencies 

• Study design, outsourcing, monitoring, and evaluation at contract research organizations (CROs) 

• Interpretation of biocompatibility and safety assessment results in accordance with EN ISO 10993-1:2009 and subsequent amendments 

Pharmacological Services for Medical Devices

• Pharmacological, Immunological and Metabolic (PhIM) assessment for substance based medical devices in accordance with MDR 2017/745 and relevant MEDDEV guidance.
• Scientific justification of the principal mechanism of action and demonstration that the device does not achieve its primary intended action through pharmacological, immunological or metabolic means.
• Mechanism of action evaluation and regulatory support for borderline and complex combination products
• Strategic support for the selection and design of in vitro, ex vivo and non clinical studies supporting the claimed mechanism of action.
• Development of robust scientific and regulatory rationales to support device qualification, technical documentation and notified body interactions.