Do my instructions for use fulfil the requirements for CE and Himi number?

What is important in instructions for use for a medical device?

Der Inhalt einer Gebrauchsanweisung für ein Medizinprodukt hat es in sich. Aus vielen verschiedenen Richtungen kommen die Anforderungen und nicht immer sind diese Quellen den Herausgeber*innen bekannt. Natürlich gilt es zunächst in die Verordnung (EU) 2017/745 or MDR , for short.
Initially, it says quite dryly:

"'Instructions for use' means information provided by the manufacturer informing the user of the intended purpose and correct use of a medical device and of any precautions to be taken".

Article 7 of the MDR states that it is prohibited to

a) attribute to the device functions and properties which it does not possess,
b) create a false impression regarding the treatment or diagnosis and the functions or properties that the device does not possess,
c) do not inform the user or patient of the expected risks associated with the use of the device in accordance with its intended purpose,
d) recommend uses for the device other than those indicated as being part of the intended purpose for which the conformity assessment was carried out.

On the way through the regulation there are various references to the instructions for use. However, what is really important for the content is MDR Annex I, Section 23, which is specifically dedicated to labelling and instructions for use. Here you will find many detailed requirements divided into the following 4 areas:

1. General requirements for the information provided by the manufacturer
2. Information on labelling
3. Information on the packaging
4. Information in the instructions for use

Additional requirements

Der nächste Schritt gilt den Normen. Vielen Medizinprodukten können produktspezifische Normen zugeordnet werden. Beispielsweise finden Hersteller*innen aktiver Medizinprodukte ergänzende Anforderungen in der Normenfamilie IEC 60601, Rollstuhlhersteller*innen in der EN 12183, Prothesen- und Orthesenhersteller*innen in der EN ISO 22523 usw. Unserer Erfahrung nach sind die Anforderungen aus den Produktnormen besser bekannt als jene aus der MDR. Gänzlich überrascht zeigen sich viele, wenn weitere Anforderungen aus dem Textilkennzeichnungsgesetz zu berücksichtigen sind oder aus dem Sozialgesetzbuch beachtet werden müssen. Mit letzterem haben alle aus dem Hilfsmittel- / Himi-Bereich zu tun. In allen 37+4 Produktgruppen (PG) des list of medical aids (Hilfsmittelverzeichnis, HMV) at least "Technical data according to section V" must be checked for completeness when applying for a Himi number.

Example

According to the medical requirements of the GKV under "V. Requirements for product information", the instructions for use of a product in product subgroup 18.51.05xxx, for example, are required:

The following must be verified

1. Listing of the technical data/parameters in accordance with application form section V
2. Proper and safe handling by means of generally understandable instructions for use in German with at least the following information:

• Instructions for use
• Intended use of the product/indication
• Permitted operating conditions/locations of use
• Existing application risks and contraindications
• Cleaning instructions
• Disinfection instructions
• Maintenance instructions
• Technical data/parameters
• Instructions for reuse with other insured persons and the measures required for this
• Assembly and installation instructions

Variations

Many of these Himi-specific topics are also covered in the MDR or the product standard. Nevertheless, there are very often very specific requirements for cleaning a medical device, for assembly or equipment, etc.

The most frequent deviations are to be found in products for which there is no product standard. For example, the instructions for use for positioning aids must contain information on

• Volume weight
• compression hardness
• the permissible body weight (upper and lower limit)
• the material used
• Required filling quantity - for air-filled seat rings - in correlation with the patient's weight
• Weight limit

⇒ These points cannot necessarily be read from the MDR requirements. Conclusion

Conclusion

As the completeness and correctness of your instructions for use is also a basis for your CE labelling and may be used in the Himi application procedure, these should be checked and kept up to date at regular intervals. We will of course be happy to help you with this. Do not hesitate to contact us for a dialogue and professional exchange. Contact us!

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