bio_subbu

Forum Moderator
Moderator
#2

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Yasuaki

Starting to get Involved
#4
Its Article 123 says,
"It shall apply from 26 May 2020."

We must start busy years, because of not only MDSAP but also MDR.
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#5
The new regulation's entry into force is 20 days after publication, initiating the transition period when both the directive and the new regulations will be applicable.

The 26 May 2020 date is (more or less) when only the new regulation will be left.

The transition period is a little different from the usual, there's a lot of rules that have to be followed. There's several types of devices that in practice won't be able to wait until 2020 (or the other extension).
 

L_O_B

Starting to get Involved
#8
I have heard several customers over the last years asking for a gap analysis and here is what I told them:

A gap analysis between MDD and MDR is a lot of work for almost no benefit.

The MDR contains a lot of information and by far not everything has an impact on economical operators.
-> so filter what is important for your business

The MDR contains a lot of requirements, which were already part of (harmonised) standards (e.g. ISO EN 13485:2016, ISO EN 14971:2012, ISO EN 14155:2011) or guidances (e.g. MEDDEV 2.7/1)
-> I guess most of the people here work in companies, which are already producing/selling devices. The main pillars of regulatory compliance are:
Risk Management
Usability
Clinical Evaluation
Labeling
Post-market surveillance
and all this should be part of a working quality management system.
This is nothing new but the status how it already should be.
So in order to comply with the MDR, instead of torturing yourself through articles about how frequently the MDCG shall meet or how the commission shall establish the interface of Eudamed (and also searching for equivalences in the MDD for that), it may be smarter to check for gaps between what you already have established and what the MDR requires.
Additionally, if you have already or are about to implement standards like ISO 13485:2016 or IEC 62366-1, you would have twice the work (first the gap analysis between MDR and MDD; second the gap analysis between standard and MDR).
The technical documentation is another good example for this. The MDD has almost no requirements on the format of the technical documentation. So people decided to use templates like STeD. If you use such a template, where is the benefit in comparing MDD and MDR requirements on this topic.

There are sections where a gap analysis between MDR and MDD might help (general safety and performance requirements <-> essential requirements), but for the whole document this is not helpful

The MDR is no MDD 2.0.
 

nozzle

Starting to get Involved
#10
I have heard several customers over the last years asking for a gap analysis and here is what I told them:

A gap analysis between MDD and MDR is a lot of work for almost no benefit.

The MDR contains a lot of information and by far not everything has an impact on economical operators.
-> so filter what is important for your business

The MDR contains a lot of requirements, which were already part of (harmonised) standards (e.g. ISO EN 13485:2016, ISO EN 14971:2012, ISO EN 14155:2011) or guidances (e.g. MEDDEV 2.7/1)
-> I guess most of the people here work in companies, which are already producing/selling devices. The main pillars of regulatory compliance are:
Risk Management
Usability
Clinical Evaluation
Labeling
Post-market surveillance
and all this should be part of a working quality management system.
This is nothing new but the status how it already should be.
So in order to comply with the MDR, instead of torturing yourself through articles about how frequently the MDCG shall meet or how the commission shall establish the interface of Eudamed (and also searching for equivalences in the MDD for that), it may be smarter to check for gaps between what you already have established and what the MDR requires.
Additionally, if you have already or are about to implement standards like ISO 13485:2016 or IEC 62366-1, you would have twice the work (first the gap analysis between MDR and MDD; second the gap analysis between standard and MDR).
The technical documentation is another good example for this. The MDD has almost no requirements on the format of the technical documentation. So people decided to use templates like STeD. If you use such a template, where is the benefit in comparing MDD and MDR requirements on this topic.

There are sections where a gap analysis between MDR and MDD might help (general safety and performance requirements <-> essential requirements), but for the whole document this is not helpful

The MDR is no MDD 2.0.

Thanks for taking the time to reply.
We received a major non-conformance from our NB last week as we don't have a procedure for conducting clinical evaluation. The company have never been cited for this in the past, do you have an example procedure?
 

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