Clinical Evaluation Report (CER)

Clinical Evaluation Report (CER)

We provide comprehensive Clinical Evaluation Report (CER) services aligned with major global regulatory requirements, including EU MDR 2017/745, UK Medical Devices Regulations 2002 (UKCA), US FDA clinical evidence requirements (21 CFR Parts 812, 814, and 820), Health Canada Medical Devices Regulations (SOR/98-282), Japan PMD Act (Pharmaceuticals and Medical Devices Act), China NMPA medical device regulations, and Australian Therapeutic Goods Act (TGA). Our CER services are designed to demonstrate the safety, performance, and clinical benefit of medical devices across their entire lifecycle, supporting pre-market approvals, conformity assessments, registrations, and post-market compliance for all device classes, including implantable, active, and software-based medical devices (SaMD).
Our clinical evaluation activities follow internationally recognized guidance and standards, including MEDDEV 2.7.1 Rev. 4, applicable MDCG guidance documents (e.g., MDCG 2020-6, MDCG 2020-13, MDCG 2021-24, MDCG 2022-2), IMDRF, SaMD clinical evaluation guidance, PRISMA guidelines, ISO 14155 (Clinical Investigation of Medical Devices), and country-specific guidance issued by Health Canada, PMDA (Japan), and NMPA (China) to ensure scientific rigor, regulatory acceptability, and global alignment.
SARACA’s Clinical Evaluation Services include:
– Preparation of Clinical Evaluation Plans (CEP) aligned with EU MDR Annex XIV, Health Canada clinical evidence expectations, PMDA consultation requirements, and NMPA clinical evaluation pathways
– Systematic literature searches and reviews conducted in accordance with PRISMA, MEDDEV 2.7.1 Rev. 4, and applicable MDCG guidance
– Clinical data appraisal, evidence grading, and relevance assessment per IMDRF clinical evidence principles and country-specific evaluation criteria
– Equivalence and predicate device assessments, including:
– EU MDR Article 61 / MDCG 2020-6
– FDA predicate comparison principles
– NMPA equivalence and clinical evaluation exemption catalog
– Clinical evidence synthesis supporting safety, performance, effectiveness, and benefit–risk acceptability