End of the MDR deadline 2017/745: How to use the time effectively

One year later than originally scheduled, the transitional period of the European Medical Devices Regulation 2017/745 now ends on 25 May 2021. Due to the Corona pandemic, manufacturers have been granted an additional year to adapt their medical devices to the regulatory requirements. How to use the remaining time effectively and what to consider:

An overview.

Technical documentation
According to MDR 2017/745 more central than ever: The technical documentation contains all relevant information and documents of a medical device and is a prerequisite for its approval. The specific structure of the document is specified in even greater detail by the MDR. Also new is the role of a responsible person who is committed to the preparation and monitoring of the EU declaration of conformity and technical documentation.
After placing on the market
Also specified by the MDR: The technical documentation must also be updated after the product has been placed on the market. The storage period of the files is at least ten years for medical devices and 15 years for implants.
Error prevention
This makes it all the more crucial for manufacturers to have structured work processes in order to avoid errors in the preparation of the technical documentation right from the start. Time and resource constraints before the end of the transition period should not affect this. Software systems validated according to ISO 13485 offer solutions, because they guarantee structure in audit-proof environments.

Structure instead of document jungle

The regulatory requirements of MDR 2017/745 are extensive and growing. Preparing the results of different processes in consideration of the regulatory requirements is quite complex – and prone to errors. Especially the obligation to update and document according to MDR, which covers the entire product life cycle, complicates decentralised working methods.

Validated software solutions such as the BAYOOSOFT Risk Manager create the advantage here. The authorisation accelerator makes it possible to record all relevant information in a clearly structured environment. This information is stored centrally in an audit-proof manner and dynamically linked in a fine-granular manner – automated up-to-dateness at the push of a button.

The time factor: software solution as approval accelerator?

Medical device manufacturers have only a few weeks left until the end of the transition period. In addition to a structured methodology for the preparation of technical documentation, they can make optimal use of the remaining time.

Extension Module Essential Requirements

The BAYOOSOFT Risk Manager uses the set of normative requirements according to MDR 2017/745 in the extension module Essential Requirements. This makes gelingt particularly easy:

the classification of the medical device according to MDR classes
the verification of compliance with essential requirements by means of an interactive list

As a validated classifier according to MDR 2017/745, the BAYOOSOFT Risk Manager provides manufacturers with an initial indication of the classification of the medical device by means of a questionnaire. In addition, only a justification is required, taking into account the intended purpose and the associated risks.

Save valuable working time and thus accelerate the approval of medical devices?

As a fully automated and intelligent software solution, the BAYOOSOFT Risk Manager offers precisely these advantages. While the technical documentation is analysed and checked for inconsistencies after the programme starts, a self-learning knowledge database is generated from all the documentation created to date and provides valuable implementation assistance.

Users are guided through the process quickly and easily. The dashboards provide an overview of where one is in the process at any given moment – regardless of whether one is

Requirements Management

Risk Analysis

Usability Engineering

Clinical Evaluation

Proof of conformity with the Machinery Directive and the standard for medical electrical equipment.

Another advantage of the software solution: Based on pre-configured standard processes, the BAYOOSOFT Risk Manager is ready for immediate use. Extension modules also enable the standard-compliant creation of the usability engineering file according to IEC 62366, the conformity report according to ISO 60601-1 as well as the fulfilment of the essential requirements according to IVDR 2017/746.

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End of the MDR deadline 2017/745: How to use the time effectively

An overview.

Structure instead of document jungle

The time factor: software solution as approval accelerator?

Save valuable working time and thus accelerate the approval of medical devices?

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