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Do My Instructions For Use Fulfil CE and HMV Requirements?

What is important when it comes to instructions for use for a medical device?

The content of an instruction manual for a medical device can be quite tricky. The requirements come from many different directions and these sources are not always known to the editors. Of course, the first thing to do is to look at Regulation (EU) 2017/745 , or MDR for short.
In a very dry way, it begins by stating:

Instructions for use” denotes information provided by the manufacturer, in which the user is informed about the intended purpose and correct use of a product as well as any precautionary measures to be taken.

Article 7 of the MDR states that it is not necessary to,

“a) ascribing functions and properties to the device which the device does not have;
b) creating a false impression regarding treatment or diagnosis, functions or properties which the device does not have;
c) failing to inform the user or the patient of a likely risk associated with the use of the device in line with its intended purpose
d) suggesting uses for the device other than those stated to form part of the intended purpose for which the conformity assessment was carried out.“

 

Scanning through the regulation there are various references to the instructions for use. However, the MDR Annex I, Section 23, which is specifically dedicated to labelling and instructions for use, is really important for the content. Many detailed requirements can be found here, 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

Supplementary Requirements

The next step concerns the standards. Product-specific standards can be assigned to many medical devices. For example, manufacturers of active medical devices will find additional requirements in the IEC 60601 family of standards, wheelchair manufacturers in EN 12183, prosthesis and orthotic manufacturers in EN ISO 22523, etc. In our experience, the requirements from the product standards are better known than those from the MDR. Many are completely surprised when further requirements from the German Textile Labelling Act have to be taken into account or from the German Social Code. Everyone in the field of medical technical aids has to do with the latter. In all 37 + 4 product groups of the German medical technical aids register, at least “Technical data according to Section V” must be checked for completeness when applying for your aid to be listed.

Example

Under Section V “Anforderungen an die Produktinformationen”  instructions for use of a product subgroup 18.51.05.Xxxx product the following has to be proven:

  1. List of technical data / parameters according to application form Section V
  2. Correct and safe handling through generally understandable instructions for use in German with at least the following information:
  • Instructions for use
  • Purpose of the product / indication
  • Permissible operating conditions / locations
  • Existing application risks and contraindications
  • Cleaning instructions
  • Disinfection instructions
  • Maintenance instructions
  • Technical data / parameters
  • Information on re-use by other insured persons and the necessary measures
  • Assembly and installation instructions

Frequent Deviations

Many of these HMV-specific topics are also dealt with in the MDR or the product standard. Nevertheless, there are very often very special requirements for cleaning a medical product, for its basic construction or equipment, etc.

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

  • Density
  • Compression hardness
  • Permissible body weight (upper and lower limit)
  • Material used
  • Required filling quantity – with air-filled seat rings – in relation to the patient’s weight
  • Weight limit

These points cannot necessarily be read from the MDR requirements.

Conclusion

Since the completeness and correctness of your instructions for use is also a basis for your CE marking and may be used in the HMV application process, these should be checked accordingly and kept up to date at regular intervals. We are of course happy to help you with this. Do not hesitate to get in touch to discuss this in more details.

 

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