The right choice for a complex route

The path to the EC marking of Medical Devices and IVD requires a thorough and rigorous analysis and preparation of the technical reference documentation.

Thema experts accompany and support Manufacturers in the process of obtaining the CE marking for Medical Devices, IVD products (Rif. MDR (EU) 2017/745) and IVD (Rif. IVDR (EU) 2017/746).

Some services:

• IVDR Emergency Kit: the fastest solution to respond to the mail obligations of the IVDR (EU) 2017/746.
• MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices.
• Feasibility analysis for verification of compliance with safety and efficacy general requirements necessary to obtain the CE marking.
• Documental Gap-analysis/orientative/pre-screening for the adaptation of the related Technical Documentation of product and system.
• Drafting related Technical Documentation of product and system.
• Drafting/updating Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER), Post Market Clinical Follow up (PMCF).
• Labelling adjustment (labels, instructions for use).
• Post-market surveillance process (PMS plan and report, PSUR, trend analysis).
• Implementation of MDR and IVD requirements related to post-market surveillance, market surveillance, vigilance and registration obligations of Manufacturer and economic operators during the “period of grace” of the CE MDD and IVD certificates.
• Support for Medical Software Validation activity.

IVDR Emergency Kit

MDR Emergency Kit

Strategic Regulatory Consulting

CE Marking Support

Italian and European Ministerial Registrations

International Registrations outside the EU

Local Representative

Quality and International GMPs