Regulatory

Device Qualification and Classification

Accurate classification of medical and IVD devices according to MDR/IVDR risk rules (Annex VIII), with supporting rationale and risk assessments.

Regulatory Gap Analysis

Identification of gaps between your current state of product design, technical file and QMS and requirements of EU MDR, EU IVDR and ISO 13485.

In-country Representation

Provision of European Authorized Representative (EU-REP) and Importer of Record services to fulfil the requirements of EU MDR/IVDR Article 11 for overseas manufacturers.

Regulatory Strategy

Developement of regulatory strategy and identification of appropriate conformity assesment pathway which leads to a succesfull CE marking and/OR EU market access.

Registration with National Competent Authorities

Handling of the complete registration process of your medical device(s) with EU National Competent Authorities after successful CE-marking across specific European markets to facilitate smooth and compliant launch in each country.

EU MDR 2017/745 & EU-REP

Regulation (EU) 2017/745 known as the Medical Device Regulation (MDR) is a European Union regulation that governs the safety and performance of medical devices within the EU.

The regulation aims to ensure higher standards of quality and safety for medical devices across the EU market. It applies to all medical devices sold in the EU, requiring compliance from manufacturers, importers, and distributors.

IVDR (In Vitro Diagnostic Medical Devices Regulation) sets stricter requirements for the safety, performance, and market access of in vitro diagnostic medical devices in the EU. It replaces the earlier IVD Directive, introducing enhanced clinical evidence, post-market surveillance, and traceability standards