Synappz © 2013

Why you should be happy

..with CE-marking

Synappz © 2013

Who are we?

Erik van der Zijden BSc MBA Piet Nelis DVM MBA Erich Taubert MD

One app, one life. At least.

Synappz © 2013

Meet the Synappz App Family

voidingdiary

Synappz © 2013

FIRST

MEDICAL APP

Ingredients for an awesome medical app

Synappz © 2013

Connect

APIsStandards (OpenEHR, HL7, DICOM)WearablesSensor Tech

See

Interaction DesignGraphical DesignCodingUse caseMarketing & PR

TrustCE certificationSector certificationNorms, Protocols (NEN7510, HIPAA)EncryptionConformity AssessmentAnonymization/Pseudonymization

Believe

Validation(Scientific) publications

Community Best PracticesExpert Co-Creation

Awards

Do Implementation ProgramTraining & Support

Change Management

Synappz © 2013

Why CE-marking?

Synappz © 2013

Deciding whether we need one

• Step 1 - Computer program? iP VD is made up of programming language, and depending on the input, iP performs a certain function. In addition, software applications are explicitly mentioned as an example of a computer. Step 1 is therefore affirmative (‘Yes’).

• Step 2 - Part of a medical device? If iP VDis regarded as part of a medical device, the medical device must be fully assessed and there is no place to independently assess iP. iP performs its function autonomously and can therefore be considered as stand-alone software. Step 2 is therefore negative (‘No’).

• Step 3 - Data handling? iP VD would fall outside the definition of a medical device if it did not handle the entered data or would merely save the data, communicate simple searches orcompress the data without any loss of data. But the data entered into iP VD are used to compile a report and to compare them with standard values (reference data). This implies that iP, based on its data processing properties, qualifies as a medical device. Step 3 is affirmative (‘Yes’).

• Step 4 - Individual medical care? The function as mentioned under step 3 is intended as abenefit for the individual user. That means the software is used for the evaluation of individual patient data or to support or influence medical care data to the individual patient. The reports in iP provide insight for the patient and the doctor in the patient’s water balance and give an indication to what extend this is abnormal. This implies iP VD provides individual care to benefit individual patients. Step 4 is affirmative (‘Yes’).

• Step 5 - Medical purpose? iP is intended by the manufacturer to be used for (diagnostic ortherapeutic) purposes as mentioned in the definition of a medical device. The insight into the patient’s water balance and the indication as to how far the patient’s data deviate from normal assist the doctor in setting a diagnosis regarding potential pathological conditions in that patient. In addition, the water balance is closely related to various physiological processes and therefore iP VD can be used to study such physiological processes. Synappz, the manufacturer of iP VD, has intended iP VD for the purposes of supporting the doctor’s evaluation. Step 5 is affirmative (‘Yes’).

Deciding whether we need one

Based on the above decision tree analysis, iP VD can indeed be qualified as a medical device.

Synappz © 2013

We needed a bit of help

Synappz © 2013

Our learnings

A lot of work, difficult to do alone.

MEDDEV important source, but lawyers still necessary.

Create clear ‘Intended Use’ statement (e.g. Withings).

Self-certification helps, but could be better (e.g. clinical validation).

We need also quality mark (e.g. VvAA/KNMG).

Regulations follows technology.

Synappz © 2013

Why you should be happy?

You’re a medical app developer in an exciting field.

Authorities take your business serious.

Separate the boys from the men.

Gain trust.

Taken seriously.

Good karma.

Hey! It’s fun to write technical dossiers.

Synappz © 2013

Don’tbe!

Synappz © 2013

hEyewayOphtalmology. Redefined.

Does it need

?

Synappz © 2013

Thank you

Erik van der Zijdenerik@synappz.nl

@ErikvdZ

+31 6 109 301 40