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Digital Health Teaser Tool

Are you developing health-related software or smart apps? Do you know if your software or app will be classified as a medical device? Does your product meet the MDR requirements? Complete our short questionnaire to find out what help you need.

If you have any questions, please contact us.

Questionnaire

1

Any software with a medical intended use could be regulated as a medical device. Have you already qualified your software as medical device?

We have not performed any assessment and would like to have more information

We have read different guidelines (MDRF, MEDDEV, MDCG, MHRA… ) but would like to have clearer guidance

Yes, we clearly understand Software as medical device definition and I know my software is a medical device

2

Have you already classified all your software and devices under the new 2021 Medical Device Regulation (MDR)?

We are not sure, and wouldlike to have more information

Our class has changed, what should we do? We’d like to have a clearer guidance

We performed an analysis and clearly know which class we are

3

If your product is classified as class IIa or higher, have you identified an accredited Notified body (NB) under MDR

We are not sure, and would like to have more information

Not yet, we are looking for a NB that could certify our product

Yes, we have already agreed the certification process under MDR with a NB

4

Have you integrated a Quality Management System (QMS) in your company?

We have no integrated QMS

We are aware of IEC 62304 and ISO 13485, but have not implemented them yet

Yes, we are certified under ISO 13485 and follow IEC 62304

5

Are you aware that most software will no longer be Class I under the MDR and will require a NB assessment unless the software is already on the market before May 2021, in which case it can continue unchanged on the market until 2025?

We are not yet aware of that and would like to have more information

We do not have an MDR readiness plan

We are aware and do have an MDR readiness plan

According to the answers provided you seem to have a strong knowledge on the new challenges and requirement of MDR 2017/745. If you would like to see how PharmaLex can deploy the full SMARTMDR engine, please reach out to us to see how we can help.
Print

On the basis of this small sample of questions, there may be some gaps remaining in your compliance and we recommend that you seek further advice. Pharmalex can assist you by deploying the full SMARTMDR engine to give you a more complete picture of what needs to be done to remain compliant. on your Medical Device Regulatory journey, Please reach out to us to see how we can help.
Print

On the basis of this small sample of questions, we strongly recommend you take immediate actions to continue commercializing your products under a monitored process. PharmaLex can assist you by deploying the full SMARTMDR engine to give you a more complete picture of what needs to be done to remain compliant, Please reach out to us to see how we can help.
Print

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