MDR – Medical Device Regulation

The European Medical Device Regulation MDR in the version 2017/745 as well as the EU Regulation on In-Vitro-Diagnostics IVDR (2017/746) replace the existing Medical Devices Directives.

MDR – Medical Device Regulation

The European Medical Device Regulation MDR in the version 2017/745 as well as the EU Regulation on In-Vitro-Diagnostics IVDR (2017/746) replace the existing Medical Devices Directives.

The MDR replaces two medical technology directives

  • Directive 93/42/EEC on medical devices (Medical Device Directive, MDD)
  • Directive 90/385/EEC on Active Implantable Medical Devices (AIMD).

For the IVDR, with its Directive 98/79/EC, a separate Regulation 2017/746 will be created.

„In a survey, the vast majority of participants (77 per cent) rated the EU MDR as „very challenging“.“

– Paragon Digital Innovation and Sustainability GmbH

Deadlines

MDR

Deadline 26.05.2021

For new medical devices according to MDR, from 26.05.2021 manufacturers may only place products on the market in conformity with the requirements of the MDR.
IVDR

Deadline 26.05.2022

The IVDR has a transitional period until 26.05.2022. Currently there are indications of a further extension until 26.05.2025.

Changes due to the MDR

The amalgamation of the previously independent guidelines has resulted in significant changes as of 01/2022.

The general, basic requirements have increased significantly in scope. Among other things, this also affects the requirements for accompanying information as well as products such as:

  • Technical documentation – Annex 2
  • Reprocessing of single-use devices
  • Post-market surveillance
  • Clinical evaluation – type and quality of clinical data
  • Products containing hazardous substances – Nanomaterials
  • Unique Device Identification UDI

New rules for the classification of medical devices have an impact on existing classifications. Existing classifications of software and implants are among the most frequently affected product groups. In addition, Class Ir for Reusable Surgical Instruments has been created. Paragon is currently developing a smart solution for the rapid classification of products in collaboration with the NMI.

The conformity assessment procedure is changing, but manufacturers can still carry out a conformity assessment without an authority. At the same time, there is an EU-wide standardisation of the tasks and test certificates of the notified bodies, the so-called MDR certificate.

In the case of products that present an increased risk, a notified body can also commission an examination of conformity by a panel of experts (Medical Device Coordination Group).

The requirement for active and comprehensive risk management adds another pillar to the requirements for the quality management system, e.g. according to ISO 13485. The retention periods for documentation increase from 5 years to 10 years.

In this context, a new role is created, the „responsible person“. This person is responsible for implementing the regulatory requirements and ensuring compliance with them.

MDR Quickscan App

With the help of the Paragon app „MDR Quickscan“ we close the gap between EU law and the implementation in practice.

The new rules present our customers with enormous challenges in terms of the new classification, the preparation of the MDR and the targeted implementation of new product developments.

With Paragon, you can process all three categories within one app.

Classification – promised simple

With the help of Paragon, the classification of a product is easier and faster than with any other product.

Our intelligent software takes into account all requirements from the current requirements through a user dialogue and thus determines the correct classification within a few minutes.

Quick Scan – a checklist to get ready for the MDR

The targeted support of companies on the way to implementing the MDR, no problem with the help of the MDR Quickscan.

The evaluation of one’s own company, based on a checklist, creates transparency on the status of one’s own project. A targeted transfer into measures for open points is included.

Deep Dive –
a digital assistent during the product development process

Meeting the relevant requirements is easier than ever with the help of Paragon.

You choose your classification and Paragon extracts the relevant requirements from the current MDR fully automatically. A structure for carrying out audits accompanying product development, which has been tested thousands of times, makes the fulfilment of requirements transparent and comprehensible.

Companies

Suitable for any size of business.

Requirements

Requirements according to 2017/745, always up to date.

Full Digital

Digitalisation in action with convincing end2end processes.

GPDR Conform

Data protection and use in accordance with the requirements of the GDPR.

Unternehmen

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