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Assion are experts in the most up-to-date regulatory compliance for new Medical Devices and In-vitro Diagnostics Regulations.

Assion are experts in the most up-to-date regulatory compliance for new Medical Devices and In-vitro Diagnostics Regulations.

Medical Devices and IVD

Regulatory Affairs

Medical devices and in vitro diagnostic tests must have a CE Mark before they can be introduced into the EU. We are experts in regulatory compliance with the new Medical Device (EU 2017/745) and In-vitro Diagnostics Regulations (EU 2017/746) which came into force in May 2017 as well as the outgoing Medical Devices and in vitro Diagnostics Directives 93/42/EC and 98/79/EC.

We provide a full range of regulatory, quality and design documentation services for a wide variety of medical technologies including:

Classification rules

  • Strategic support in the MD classification

Support during the development

  • Definition of the best strategy
  • Support in managing the Suppliers involved in the manufacturing processes, biocompatibility studies and clinical studies
  • Assessment of the data generated during the development

CE marking procedures

  • Selection and contacts with the Notified bodies
  • CER and BER preparation
  • Technical files preparation
  • Management of the procedure up to the CE marking

Quality Management System and Post-Market Surveillance

  • Implementation of Quality management systems (SOPs, etc)
  • Audits
  • Post marketing surveillance procedures

EU Medical Device Regulations (MDR)

The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

Assion specializes in supporting your company when you are looking to sell medical devices in Europe. Your products will need to comply with new EU Medical Device Regulation (MDR) requirements and we have the experts on hand to assist you in EU MDR compliance, typically through

  • A comprehensive review of product portfolios and current certificate expiry dates
  • A Gap assessment
  • Remediation and implementation of an EU MDR compliance plan


Market Access

In order to achieve successful market access, it is essential for medical device manufacturers to understand market dynamics, requirements, assessment criteria and most importantly, associated stakeholders.
Our expertise in supporting medical device manufacturers fall into:

Landscape Assessment
  • MD reimbursement is country specific and needs to be evaluated on a country by country basis
  • Gap analysis
  • Development of Pricing and Reimbursement strategy
Data generation and risk mitigation
  • Modelling
  • Study design
  • Surveillance
  • Country specific dossier development, DRG inclusion and negotiation
  • KOL engagement

Talk to one of our experts

Medical devices an Assion case study

Our client was undertaking the development of a medical device but unfortunately had no internal resources to manage the development and CE marking procedure to what was a tight schedule.