Medical Device Regulations - Curse or Blessing?

Im Mai 2020 wird die neue Medizinprodukteverordnung (MDR) in Kraft treten. Um Unsicherheiten und offene Fragen...

Medical Device Regulations

... rund um das Thema zu klären, haben wir am 16. Mai, neben anderen Health Startups,  Experten auf diesem Gebiet eingeladen. Wir sind der Meinung, dass Gesundheitsunternehmen alle im selben Boot sitzen und das Teilen verschiedenster Erfahrungen uns gemeinsam nach vorne bringen kann.

Neben unserem Gesundheitsteam Dr. Maya Fehling und Dr. Tamara Radaković, haben wir Dr. Matthias Merx (LaGeSo), Dr. Michael Berensmann (TÜV Rheinland LGA Products GmbH), Robert Dick-Hambeck und Astrid Schulze (Johner Institut GmbH) zu unserer Podiumsdiskussion über Fluch und Segen der Medizinprodukteverordnung (MDR) eingeladen.

Das Ergebnis ist unter anderem unsere LinkedIn Arbeitsgruppe, in der alle Interessierten Fragen stellen, Beiträge teilen und zukünftige Veranstaltungen verfolgen können. 

Da dieses Thema generell auf Englisch diskutiert wird und auch das Meetup in Englischer Sprache war, stellen wir die wichtigsten Erkenntnisse der Veranstaltung in diesem Blogbeitrag auch in Englischer Sprache vor:

/ENGLISH/

The Medical Devices Regulation (MDR) will come into force in May 2020. In order to address uncertainties and open questions around the topic, on the 16th of May we hosted a Meetup in Vivy’s offices. Health companies are all in the same boat and the idea was to invite experts in the field who will tell a story from different perspectives and health startups who are currently under the process or are already a registered medical product. We invited Dr. Matthias Merx (LaGeSo), Dr. Michael Berensmann (TÜV Rheinland LGA Products GmbH), Robert Dick-Hambeck and Astrid Schulze (Johner Institut GmbH) to join our panel discussion about the curses and blessings of the Medical Device Regulation (MDR) together with our health team Dr. Maya Fehling and Dr. Tamara Radaković.

As a result of a very fruitful discussion we have formed a working group on LinkedIn Arbeitsgruppe, where we invite everyone who is interested in the topic to join, raise questions and follow up on future events. Here are the most important insights discussed in the event:

How can a small startup with limited resources make it through the implementation of MDD/MDR?

Robert Dick-Hambeck suggested that using a ticket management software like JIRA or Trello from the beginning can be a first step a small team can take in order to get a better understanding and get used to working according to the processes. The team can start from structuring containers/projects in a ticket manager for each chapter according to ISO 13485 (QMS) including software development, change management, complaint management etc. There your JIRA workflows can represent the first draft of the processes of your company. Note that when it comes to software lifecycle requirements (IEC 62304), having this only is not sufficient to meet legal requirements. This advice is aiming only to help a small team on where to start. The next step in order to understand how to establish wholesome quality management system would be to dive deeper into the specific phases in product development like product discovery (define intended use, requirements, acceptance criteria, design according to usability standards), development, release process (verification that the product fulfilled defined requirements) and maintenance. Therefore you should consider to get an expert on-board to ensure that these phases are properly documented and that they meet the necessary legal requirements.

Dr. Michael Berensmann and Dr. Matthias Merx emphasized that getting somebody on board with experience from the very beginning may prevent a lot of unnecessary financial losses, repeating other people's mistakes and even failing the audit. For covering the high costs of working with external consults Dr. Tamara Radakovic advised that health startups can include these costs as a part of a business plan and negotiation with investors.

Who does the digital health company need to hire in order to be MDR compliant?

According to the MDR, article 15, it is necessary to have at least one role responsible for regulatory compliance. In case you fall under the definition or a ‘Micro’ (<10) or ‘Small Enterprise’(<50) (as per 2003/361/EC) you can also outsource this role outside of Europe. The key is that the person or team fulfilling this role must be permanently and continuously at your disposal and must meet the required qualifications. 

What is a decisive factor in becoming a medical product and not a lifestyle app? Benefits, the importance of classification and more. 

It seems that there are a lot of apps on the market with similar intended use, making similar promises to the customers, yet some are classified as a lifestyle product and some as a medical one. The question was raised on what is the value of becoming a medical product? Dr. Mathias Merx explained, that the key is the targeted user group and market. If the product is intended to be sold in the professional area, it may be important to state that it is a medical device and has undergone a conformity assessment procedure to ensure patient safety and product performance. If a company claims their product has a medical benefit, but is not registered as a medical product, the `Medizinproduktegesetz`can still apply with all the consequences. 

He also reminded us that there are many apps out there on the market categorized as lifestyle apps that nobody looks at, that still might do damage to the people who are using it. Other products decided to become medical products and went through an extensive process of becoming one.  Is it worth the effort? Many companies claim it is. Dr. Merx also added that he understands that it is a tough thing to sell the benefit of developing a CE labeled product to investors at the end of the day, since they are always a bit shy when it comes to giving money.

How do authorities become aware of misclassified products and what are the legal consequences for those products?

We have learned that LaGeSo Berlin, as the law enforcement for the “Medizinproduktegesetz”, is responsible for the monitoring of the manufacturers of medical devices in Berlin. A product not registered as a medical device is not in the view of the authority. Dr. Merx explained that authorities have to follow up on the reports they receive on misclassified products, but if the company does not claim to produce a medical product, the intended use and advertisement statement claim that the product is not a medical product, authorities can do very little. However, if the advertisement of a product and its intended use sound like a medical product, then authorities have a reason to step in and investigate. 

When it comes to the legal consequences of misclassified products, Robert Dick-Hambeck explained that it all comes down to the level of harm a product can cause. Companies are violating MDD rules and the law when they misclassify their product, put it on the market and advertise it in a misleading way. In that case, consequences range between written warnings to serious fines, depending on the violation of the MPG. Dr. Merx explained, if a product poses a serious threat to the health of patients, users or third persons, the authorities can shut down the company and its operations immediately.

What Certification do you need for MDR?

Dr. Michael Berensmann from TÜV Rheinland LGA Products GmbH said that it is necessary to comply with the essential requirements of MDD related to software development according to the state of the art, quality management system, risk assessment and usability. Harmonized standards recognized by the European Union are  IEC 62304 (software development), ISO 13485 (quality management systems), ISO 14971 (risk assessment) and IEC 62366 (usability). A better overview can be found on the European Union webpage page on medical device directive.


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