Software in Medical Devices, by MD101 Consulting

Proposal for MDR 2017/745/ UE amendment

At the end of article 2 Definitions, add the following paragraph:

(72) Substantial equivalence: A device is substantially equivalent if, in comparison to a predicate it:

• has the same intended use as the predicate; and has the same technological characteristics as the predicate; or
• has the same intended use as the predicate; and has different technological characteristics and does not raise different questions of safety and effectiveness.

At the end of article 61 Clinical Evaluation, add the following paragraph:

14. Alternatively to paragraph 1, for all devices other than class III devices or class IIb devices referred to in point (b) of Article 54(1), the manufacturer may demonstrate the safety and performance of medical devices by substantial equivalence.
The information present in the technical documentation, as set out in annex II, demonstrates that the device is as safe and effective as the legally marketed device.

The technical documentation establishes that:

• the new and predicate devices have the same intended use and any differences in technological characteristics do not raise different questions of safety and effectiveness;
• the device is as safe and effective as the predicate device by scientific methods used to evaluate differences in technological characteristics and performance data.

In Article 120 Transitional provisions:

Replace every occurrence of:
27 May 2022
by:
27 May 2032,

Replace every occurrence of:
27 May 2024
by:
27 May 2034,

Replace every occurrence of:
27 May 2025
by:
27 May 2035,

In Article 121 Evaluation:

Replace:
By 27 May 2027,
By:
Every two years, starting from 27 May 2023.

In annex VIII Classification, chapter III, paragraph 6.3

Replace:
Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes
By:
Software intended to provide information which is directly used to take decisions with diagnosis or therapeutic purposes

Key takeaways

As you can see, it solves the current bottleneck by:

• enlarging the duration of the transition period for legacy devices,
• alleviating the overhead of the MDR on innovative devices.

Send this to your colleagues at Health and Food Safety Directorate. They will update other articles for consistency. They have plenty of skilled lawyers able to do it promptly.
Feel also free to tell them to update other rules of annex VIII, to retrieve a reasonable classification system. Less class III and more class I will be more in line with what other MD regulations do.

Last thing: don't forget IVDR. It's the elephant in the room.

Warm Regards.