How medical software manufacturers manage the transition from the MDD to the MDR - case study from practice

A Swiss manufacturer of eHealth applications has had the diabetes software developed for it transferred from the MDD to the MDR in good time. This was achieved even though it was initially unknown how long the transition to the new MDR regulations would take.

Sinovo Health Solutions GmbH, which is responsible for the software development and commercialisation of the diabetes software for the leading Swiss manufacturer, had successfully started planning and implementation.

Sinovo's MDD certificate (Medical Device Directive certificate) would remain valid. However, no significant changes had to be made to the diabetes software, which were also affected by bug fixes. If software adaptations had nevertheless been implemented, the medical software would no longer have been allowed to be sold within the EU, as it would have had to be withdrawn from the market.

Medical device manufacturers, including medical software manufacturers, had to have implemented the EU's MDR (Medical Device Regulation) regulations by 21 May 2021. Existing MDD certificates will be valid until 26 May 2024.
The MDR replaces the existing MDD. The aim of the MDR is to increase the safety of medical devices, provide better protection for patients and ensure greater transparency and simple traceability of medical devices.

In this case study, you will find out where the hurdles lie for the medical software manufacturer and how it overcame them.

What six hurdles has the medical software manufacturer identified for itself?

Jan Filip, Managing Director of Sinovo Health Solutions GmbH, explains: ‘Together with our customers, we had six major hurdles to overcome:

1. a lack of internal resources to manage the transition to MDR,
2. the conformity of information on manufacturers and products with the requirements of EUDAMED (European database for medical devices),
3. the capacity of notified bodies (state-supervised test centres),
4. the time required for clinical data collection
5. the preparation of Clinical Evaluation Reports (CER) and their continuous updating and maintenance,
6. sustainable post-market surveillance."

Filip adds: ‘Before embarking on an MDR project, the question should be answered as to which medical software will be worth the regulatory effort in future.’ Small and medium-sized companies in particular face the challenge of coping with the costs associated with the new regulation. The timeframes required for certification also represent an additional challenge, as they often have neither the relevant processes in place nor the personnel capacity.’

According to a survey by the industry association BVMed, the documentation effort for medical device manufacturers has increased tenfold (source: BVMed autumn survey 2019, accessed on 26.07.2021, https://www.bvmed.de/de/bvmed/presse/pressemeldungen/stimmung-in-der-medtech -branche-eingetruebt).

What was done to manage the MDR changeover?

There were essentially 3 aspects that were tackled at very short notice in order to manage the MDR changeover.

1. First MDR audit planned 1 year before the MDD certificate expires

The strategy for notified bodies should be a high priority and was therefore launched very recently. The reason for this is that the search for notified bodies that still have capacities available can take several weeks until they are commissioned, and in this case it did.

After the first MDR audit and the assessment of the product documentation, it currently takes several months before a new MDR certificate can be issued. The reason for this is the high demand from the notified bodies that issue the certificate. For this reason, the first MDR audit was scheduled one year before the expiry date of the MDD certificate.

As the certification process, including any anomalies in the technical documentation, must be completed within 6 months, sufficient time and resources were provided to adapt the technical product documentation and the documentation within the quality management system as early as possible.

2. Validity date of the current MDD certificate checked so as not to miss any expiry or transition periods

The transition to MDR certification must be completed before this specified validity date. This not only includes an audit and certification of the quality management system. The product documentation must also be assessed in accordance with the new MDR requirements. The clarification of related issues or the handling of non-conformities can lead to further delays. Sufficient time has also been set aside for this.

3. Changeover from MDD to MDR already prepared approx. 1.5 years ago

A new MDR certificate will be required at the latest when the MDD certificate becomes invalid. This is why preparations, gap analyses and resource planning were started in good time. This took around 1.5 years to complete. The more time that is allowed, the better.

The preparations after the gap analyses included, for example:

• the product documentation and the documentation of the Post-Market Surveillance Reports (PMS report for Class I medical devices) and Periodic Safety Update Reports (PSUR for Class IIa and higher devices),
• the reassessment of medical devices according to risk class,
• setting up a new risk management system,
• the implementation of processes for the creation, updating and maintenance of Clinical Evaluation Reports,
• organising a strategy and corresponding processes for post-market surveillance.

Making strategic decisions for the future

Even if the MDR certificate was available in May 2021, it is advisable to continue to deal with the effects and conversion efforts of the MDR beyond that date.

Filip therefore advises: ‘The challenges and obstacles to achieving MDR compliance are numerous and varied.’ Medical software manufacturers should therefore start planning now for the two to five years after obtaining the MDR certificate. There is still time to develop sustainable strategies to manage the short, medium and long-term effects of the MDR transition.’

SINOVO health solutions GmbH

SINOVO has been producing medical apps and software since 2005. The software products are developed in accordance with the ISO 13485 standard and with CE labelling. With innovative digital solutions, SINOVO is one of the pioneers in telemedicine. In cooperation with the team of Prof. Dr Bernhard Teupe, SINOVO has developed a therapy app for type 1 diabetics based on anonymised data sets from more than 15,000 test subjects.

Press Contact

SINOVO health solutions GmbH, Tanja Schönfeld, Willy-Brandt-Str. 4, 61118 Bad Vilbel, Tel.: +49 6101 590 90 00, E-Mail: presse@sinovo.de , Web: sinovo.de