J
esalsan, thank you for the additional input.
I did receive input from Swissmedic this morning. See below.
Abstract from the Medical Devices Ordinance:
Article 7 Product information
1 Product information shall be in accordance with:
a. Classical medical devices: Annex I, Section 13 of the Directive 93/42/EEC43; b. Active implantable medical devices: Annex 1, Sections 14 and 15 of the Directive 90/385/EEC44; c. Medical devices for in vitro diagnosis: Annex I, Section 8 of the Directive 98/79/EC45.46
2 The product information must be written in all three official languages. Symbols which are contained in harmonized standards can replace wording.
3 Product information can be restricted to less than the three official languages, or be in English,
provided:
a.47 the medical device is supplied exclusively to professionals or where the medic al device is a custom-made device or a medical device manufactured in-house; b. there is assurance that the user has the necessary professional and linguistic qualifications, and agrees with the language restriction; c. the protection of patients, users and third parties is nevertheless ensured; and d. effective and intended use is not jeopardized.
4 If requested, additional information shall be given to users in one of the official languages.
5 If a product that is not, or not yet, permitted to be placed on the market as a medical device can be confused with one that is, the clames of the former must clearly and legibly indicate that it is not a medical device and is not suitable for medical purposes.
For the software interface are the same rules applicable
Swissmedic does give exemption for professional use in Rule 3. However it is followed up by additional risk concerns and then Rule 4 requiring languages to be supplied when requested.
I did receive input from Swissmedic this morning. See below.
Abstract from the Medical Devices Ordinance:
Article 7 Product information
1 Product information shall be in accordance with:
a. Classical medical devices: Annex I, Section 13 of the Directive 93/42/EEC43; b. Active implantable medical devices: Annex 1, Sections 14 and 15 of the Directive 90/385/EEC44; c. Medical devices for in vitro diagnosis: Annex I, Section 8 of the Directive 98/79/EC45.46
2 The product information must be written in all three official languages. Symbols which are contained in harmonized standards can replace wording.
3 Product information can be restricted to less than the three official languages, or be in English,
provided:
a.47 the medical device is supplied exclusively to professionals or where the medic al device is a custom-made device or a medical device manufactured in-house; b. there is assurance that the user has the necessary professional and linguistic qualifications, and agrees with the language restriction; c. the protection of patients, users and third parties is nevertheless ensured; and d. effective and intended use is not jeopardized.
4 If requested, additional information shall be given to users in one of the official languages.
5 If a product that is not, or not yet, permitted to be placed on the market as a medical device can be confused with one that is, the clames of the former must clearly and legibly indicate that it is not a medical device and is not suitable for medical purposes.
For the software interface are the same rules applicable
Swissmedic does give exemption for professional use in Rule 3. However it is followed up by additional risk concerns and then Rule 4 requiring languages to be supplied when requested.