Foundation of the Seal
As of now, there is no special certification or qualification in Europe for Internet and medical applications. Both on the part of service providers and users, but especially on the part of the product providers themselves, there is an essential need to make the quality of the products transparent, to control and prove it.
The Bundesverband Internetmedizin (BiM) has responded to this need and was the first to introduce a quality seal for these products. in doing so, the Bundeservand Internetmedizin makes use of the possibilities offered by current law.
The aim of the Bundesverband Internetmedizin is to subject the products concerned to the applicable legal regulations pf qualification and at the same time to level and promote the way pragmatically. The Bundesverband Internetmedizin also sees this task as a responsibility to counteract over-regulation by politically or economically involved bodies. Qualification in this field must remain manageable and fundable, otherwise, the purpose of broad quality assurance cannot be guaranteed.
The Bundesverband Internetmedizin awards the "Qualitätsprodukt Internetmedizin" - quality product internet medicine seal to products of internet medicine that meet the requirements of the seal and pass the corresponding test. This catalogue of requirements is based on
- The requirements of the Medical Device Act for CE certification (risk class 1)
- the FDA requirements for medical applications (also risk class 1) and
- further requirements according to experiences of the Bundesverband Internetmedizin.
Catalogue of Requirements for the Seal
The catalogue of requirements for the seal "Qualitätsprodukt Internetmedizin"/"Quality Product Internet Medicine" is subjected to secrecy and is only disclosed after an order has been placed. The catalogue categorises the corresponding requirements undet the following headings:
- General Information
- Statements by the Company
- Application for certification (BiM Internet Medicine Quality Product)
- General Information
- Quality Management
- Data Protection
- Risk Management
- seperate medical device requirements
- (MPW - risk class 1)
- FDA requirements (meanwhile optional to book)
- Documentation
- other explanations
- Report
The catalogue of requirements is divided into three columns and is filed in accordingly for the product concerned:
- column - requirements
- column - explanatory notes on compliance
- column - presentation of the company's results
The conpleted and completely filled out catalogue of requrements tigether with the required documentation is the basis for the certification examination by BiM and for the issue of the seal.
The Range of Services of the Seal
The Bundesverband Internetmedizin associates the following services with the seal "Quality Product Internetmedicine":
- BiM transmits to the applicant the catalogue of requirements especially formulated for medical internet applications and fulfilling the requirements of medical device class I with all instructions, questions and basics for the certification.
- Once the applicant has prepared a product-specific dossier from the catalogue of requirements, answered all questions and carried out the necessary documentation, they submit the dossier to BiM.
- Now the BiM audit officer checks whether the requirements are fulfilled and issues a recommendation for the award of the seal or formulates a corresponding monition.
- BiM issues a certificate to that effect and authorises marketing.
- BiM publishes the certified products on its website and issues corresponding press releases.
BiM offers this service to the applicant for 4.000,- € plus VAT.
In addition, BiM has ensured that the applicant will have access to advice when preparing the dossier, which will not exceed the cost of a further €8,000 plus VAT. Using this further advice, anyone can take the path to the seal, even if they have no experience of certification. The further consultation covers the following processing:
- Complete support and preparation of the dossier for certification by the BiM audit officer.
- The applicant only has to support this development and provide someone who knows the structures of the product. If the requirements of the catalogue are not met, the applicant may have to rework the processes. According to previous experience, about 5 appointments are required for this cooperation.
This compilation of advice is designed in particular to ensure that the prices for advice, together with BiM's services, are affordable for start-ups. Each applicant can of course work through the catalogue of requirements themselves or with other consultants and compile the dossier independently.
Interested in the Certification?
If you are interested in certification, request the certification contract from the BiM office and ask for the consultancy package if needed. For this you can either call under +49 (40) 32 52 45 58 or message us via the contact-form beneath: