In this article we will discuss key issues regarding marking and use of languages on medical products in Europe.
Our clients often ask us about labelling of products and which language that is required printed on the package. This might sound trivial, but in fact this is very important. Products can be rejected or required to be removed from the market, if the labelling and/or language requirements are not met.
Information on EU requirements for Medical Devises such as Medical Face Masks, are regulated by Medical Devices Directory 93/42/EEC and standard EN 14683:2019+AC:2019, which also applies to the EEA countries. This information is based on MDD 93/42/EEC, and on knowledge based on experience in the marked, cooperation with different Notified Bodies and professional Authorized Representatives, and communication with Norwegian Health Authorities and the EU Commission.
First: Main topics and requirements in Medical Devices Directory 93/42/EEC:
Article 1
2 (a) '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.
Comment: This means that for Medical Face Masks the smallest packaging is defined as a medical device.
Article 2.
4. Member States may require the information, which must be made available to the user and the patient in accordance with Annex I, point 13, to be in their national language(s) or in another Community language, when a device reaches the final user, regardless of whether it is for professional or other use.
Comment: Only the EU countries governmental authorities can decide exceptions for these requirements not private (economical unit) companies.
Article 11.
5. In the case of devices falling within Class I, other than devices which are custom-made or intended for clinical investigations, the manufacturer shall, in order to affix the CE marking, follow the procedure referred to in Annex VII and draw up the EC declaration of conformity required before placing the device on the market.
Article 17 CE Marking
1. Devices, other than devices which are custom-made or intended for clinical investigations, considered to meet the essential requirements referred to in Article 3 must bear the CE marking of conformity when they are placed on the market.
Annex I point 13:
13. Information supplied by the manufacturer
13.1. Each device must be accompanied by the information needed to use it safely and to identify the manufacturer, taking account of the training and knowledge of the potential users.
This information comprises the details on the label and the data in the instructions for use.
As far as practicable and appropriate, the information needed to use the device safely must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more devices.
Instructions for use must be included in the packaging for every device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they can be used safely without any such instructions.
13.2. Where appropriate, this information should take the form of symbols. Any symbol or identification colour used must conform to the harmonized standards. In areas for which no standards exist, the symbols and colours must be described in the documentation supplied with the device.
13.3. The label must bear the following particulars:
(a) the name or trade name and address of the manufacturer. For devices imported into the Community, in view of their distribution in the Community, the label, or the outer packaging, or instructions for use, shall contain in addition the name and address of either the person responsible referred to in Article 14 (2 ) or of the authorized representative of the manufacturer established within the Community or of the importer established within the Community, as appropriate;
(b) the details strictly necessary for the user to identify the device and the contents of the packaging;
(c) where appropriate, the word 'STERILE';
(d) where appropriate, the batch code, preceded by the word 'LOT', or the serial number;
(e) where appropriate, an indication of the date by which the device should be used, in safety, expressed as the year and month;
(f) where appropriate, an indication that the device is for single use;
(g) if the device is custom-made, the words 'custom-made device';
(h) if the device is intended for clinical investigations, the words 'exclusively for clinical investigations';
(i) any special storage and/or handling conditions;
(j ) any special operating instructions;
(k) any warnings and/or precautions to take;
(l) year of manufacture for active devices other than those covered by (e). This indication may be included in the batch or serial number;
(m) where applicable, method of sterilization.
13.4. If the intended purpose of the device is not obvious to the user, the manufacturer must clearly
Annex II
2. The manufacturer must affix the CE marking in accordance with Article 17 and draw up a written declaration of conformity. This declaration must cover a given number of the products manufactured and be kept by the manufacturer.
Conclusion
All types of Medical Face Mask complying to standard EN 147683:2019+AC:2019 must be marked/labelled and have information on both English and language for the local end user in each member state of EU and EEA. The labelling and required information must be placed with the CE mark on every packaging, or if possible, on each product. For Medical Face Mask the smallest packaging is defined as a medical device.
These requirements apply to all private companies. Only local Country Health Authorities can make exceptions form these requirements for governmental purchasing of such products and with responsibilities to prove evidence for conformity to quality standards and proper information to users or patients.
Marking and necessary information must be either printed on the packaging or it can be used proper understandable stickers. Packaging insert is not allowed for this purpose. Additional information can be provided as an attachment if appropriate.
This is our understanding of the relevant requirements and common practise before the Covid 19 pandemic situation.
Provida Medical AS will always strive to ensure that all relevant laws, regulations, and best practices are followed when it comes to business with medical equipment and
personal protective equipment - infection control equipment. Therefore, we place great emphasis on having up-to-date knowledge and competence about regulations that apply to both the manufacturer (local national regulations), involved parties, the importer and not least the distributor and seller (EU and national requirements).