COPD online calculator a customer case. Åse S. Mjelva LINK Medical Research AS Norway Health Tech, 16 Nov 2017
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1 COPD online calculator a customer case Åse S. Mjelva LINK Medical Research AS Norway Health Tech, 16 Nov 2017
2 LINK Medical Mission MDD support this! LINK Medical mission is to improve and accelerate our customers projects and product development Development Market Idea
3 Medical Device Department Employees
4 Agenda COPD online calculator - a medical tool that requires approval as a medical device or not What tools do you have How can you use these tools Other similar products A few extra pointers
5 COPD Online calculator
6 Tools for determining status Intended use for your product Definition of a Medical Device MEDDEV 2.1/6 Qualification and Classification of stand alone software Borderline Guideline (Other similar products)
7 The COPD Calculator COPD calculator is a neutral service developed by pulmonary specialists to assist general practitioners when diagnosing COPD, and find the right treatment The COPD calculator s main purpose is to help the general practitioner understand the Norwegian and international COPD guidelines (GOLD)
8 Definition of a Medical Device 'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
9 MEDDEV 2.1/6 Qualification and Classification of stand alone software Start 1. Is the product a software according to the definition of this document? No No 2. Is the software a standalone software according to the definition of this document? No 7. Is the software part of/ incorporated in a MD? Part of a medical device 3. Is the software performing an action on data different from storage, archival, communication or simple serach? No 4. Is the action for the benefit of individual patients? No No 5. Is it for the purposes defined in art 1.2a of Dir. 93/42 CEE? No Not a medical device 6. Is it an accessory of a MD? Medical device Covered by the medical device directives Not covered by the medical device directivs Accessory
10 The COPD Calculator MEDDEV 2.1/6 Step Question Answer Comments 1. Is the product a software according to MEDDEV 2.1/6? 2. Is the software a standalone software according to MEDDEV 2.1/6? 3. Is the software performing an action on data different from storage, archival, lossless comparison, communication or simple search? 4. Is the action for the benefit of individual patients? 5. Is the action for the purposes defined in art No Software is defined as a set of instructions that processes input data and creates output data. This web page falls under this definition. Standalone software means software which is not incorporated in a medical device at the time of its placing on the market or its making available. This web page falls under this definition. See discussion below The web page is used for classifying a single patient s degree of COPD. The purpose of the web page s functionalities include diagnosing disease. 1.2a of MDD? 6. Is it an accessory of a medical device? No This step is only necessary if the answer to Step 5. is No.
11 Borderline Guideline The Manual on Borderline and Classification in the Community regulatory framework for Medical Devices is a useful guidance for the classification of borderline medical device products. It is published by the European Commission, and the working group is chaired by the Commission and is composed of representatives of all member states of EU, EFTA and other stakeholders. The manual includes a section on software and mobile applications.
12 Bordeline Guideline cont. Case 9.4: Qualification of software for interpretation of a guideline which allows for faster consulting/reading of an international guideline regarding the Classification of Malignant Tumours (TNM) issued by the UICC (International Union Against Cancer). The doctor add three variables about the cancer to the software, and according to these the application indicates the disease s stage of development (cancer extent), according to the above-mentioned guideline. According to the borderline manual, this software is only performing a simple search and is therefore not a medical device.
13 Conclusion for COPD Calculator Based on the intended purpose; that the web site is a tool for reading a guideline, and that the web site does not do any calculations or interpretations of the data added to the web site by the general practitioner, we conclude that the web site only does a simple search as described in Meddev 2.1/6. This is also supported by the examples in the Borderline Manual. This software does not perform an action on data different from storage, archival, lossless comparison, communication or simple search; therefor it is not a medical device.
14 Other similar products If there are similar products on the market you can check what conclusion they have reached NB! This is not a final answer you have no guarantee that your competitor has done a proper assessment of the rules and guidelines You should always do your own assessment, there might be slight differences that changes the outcome for your software
15 A Few Extra Pointers Version Control Check you language do you claim anything beyond your intended use? If your software have several different functions check all of them
16 Links Regulation (EU) 93/42/EEC: MEDDEV 2.1/6 anslations Borderline Guideline: ual_en.pdf
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