A Summary of (EU) 2017/745 and (EU) 2017/746 - A Must Read for Medical Device Manufactures

If your Medical Device Company wants to gain and maintain access to one of the largest medical devices markets, the European Economic Area (EEA) it is important to stay on the top of the regulatory changes to ensure certification of your products in a timely manner. This article presents the new rules MDR (EU) 2017/745 (MD/AIMD) and MDR (EU) 2017/746 (IVD) in a nutshell.

Lead Auditor EN ISO 13485:2016 and EU MDR 2017/745 - Regulation

The Background

The new rules MDR (EU) 2017/745 (MD/AIMD) and MDR (EU) 2017/746 (IVD) took their form - to a large extent - from the existing three important directives which were familiarized over the past 20 years.

  1. Medical Devices Directive (MDD) 93/42/EEC
  2. Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC
  3. In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC

These regulations provided the essentials for a harmonized registration process and certification requirements for medical devices. They also supported the advancement of the EU's single market strategy.

The new Medical Devices Regulations are aimed at achieving greater transparency and harmonization. They have much more stringent controls and refinement requirements to enable effective medical device traceability.

Key Changes

  • stricter ex-ante control for high-risk devices via a new pre-market scrutiny mechanism with the involvement of a pool of experts at EU level.
  • the reinforcement of the criteria for designation and processes for oversight of Notified Bodies.
  • the inclusion of certain aesthetic devices which present the same characteristics and risk profile as analogous medical devices under the scope of these Regulations.
  • improved transparency through the establishment of a comprehensive EU database on medical devices and of a device traceability system based on Unique Device Identification;
  • the introduction of an "implant card" containing information about implanted medical devices for a patient.
  • the reinforcement of the rules on clinical evidence, including an EU-wide coordinated procedure for authorisation of multi-centre clinical investigations.
  • the strengthening of post-market surveillance requirements for manufacturers.
  • improved coordination mechanisms between EU countries in the fields of vigilance and market surveillance.

MDR (EU) 2017/745 (MD/AIMD) and MDR (EU) 2017/746 (IVD) encourage a much more robust product-life cycle approach with an emphasis on proactively managing device safety and performance. However, the new regulations also recognize how the advancements in technology, continuous product design innovations, and the changing healthcare systems delivered over the last twenty years have left an impact. In general, the new rules are a breakthrough to the progress of the single market strategy and accomplishing a striking a balance between the regulatory concerns and economic opportunities as envisioned by the European Union.

Replacements and Amendments

Replacements and Amendments

Transition timeline for (EU) 2017/745 (MDR & AIMDR)

Transition timeline

Transition timeline for MDR (EU) 2017/746 (IVDR)

Transition timeline

How can medical device manufactures prepare for the transition?

As a lot of work must be accomplished in a short time of the transition period, you need to get ready now to ensure your products are compliant. Here's how you can prepare:

  • Ensure that all relevant professionals at your company have a thorough understanding of the new regulation including key changes.
  • Perform a thorough gap analysis to review your existing products with the new regulation. In the gap analysis, also consider the reclassification of some product groups and the MDRs description of a medical device.
  • Attend relevant training programs for compliance with the medical device regulations.

Supplementary information for manufacturers interested in selling their medical devices in the European Union:

To sell their devices in the European markets Manufacturers must meet the Medical Device Directives' quality standards. The EN ISO 13485 meets most of the QMS requirements outlined in the Directives. Many successful medical device companies choose to implement it prior to entering the EU medical device markets. Browse through medical device training programs and choose a relevant training program that provides a thorough understanding into its implementation.

The webinars Post Market Surveillance with the new Medical Device Regulation EU MDR 745/2017 and Supplier Management with the new Medical Device Regulation EU MDR 745/2017 provide specific supplementary information on the topic in detail.