In May 2017, the European Commission published two new regulations: the Medical Devices Regulation – MDR (Regulation (EU) 2017/745) and the In Vitro Diagnostic Medical Devices Regulation – IVDR (Regulation (EU) 2017/746). With the application thereof, Directives 90/385/EEC and 93/42/EEC, on the one hand, and Directive 98/79/EC and Commission Decision 2010/227/EU, on the other, are respectively repealed.
The aim of the new Medical Devices Regulations is to reinforce the traceability and safety of these devices in Europe. The regulations should have entered into force on 26 May 2020, with a transition period of 3 years for the MDR and 5 years for the IVDR. However, due to the SARS-CoV-2 pandemic, the European Commission proposed that application of the regulations be postponed for 1 year (until 26 May 2021).
With the upcoming application of the Regulations, manufacturers must adopt certain measures and comply with new requirements related to the marketing and labelling of their products, among other requirements.
At Siens Translation, we have compiled a list of the points that affect the translation of the documents of your medical devices to give you an idea of the linguistic requirements demanded by the new Regulations.
How do the new Regulations affect the translation of the documents of your medical devices?
Labelling and instructions for use
- In Annex I of the MDR, section 23 of Chapter 3 presents a list of the information that manufacturers must provide in the labelling and instructions for use of a device (trade name of the device, the contents of the packaging, the intended purpose, etc.). This information must include the identification of the device and its manufacturer, as well as any safety and performance information relevant to the user or operator. Moreover, if the manufacturer has a website, this information must be made available there and be kept up to date.
In this regard, Chapter II, Article 10, paragraph 11 of the MDR specifies the language in which such information must be provided:
“Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.”[1]
- Chapter 1 of Annex II (“Technical Documentation”) of the MDR details the information that is required in technical documentation (product name, general description of the device, intended purpose and intended users, the UDI, the medical conditions to be diagnosed, principles of operation of the device, etc.).
It also specifies the information that the manufacturer must provide (Annex II, chapter 2 of the MDR) and the language of that information, namely:
“A complete set of:
— the label or labels on the device and on its packaging, such as single unit packaging, sales packaging, transport packaging in case of specific management conditions, in the languages accepted in the Member States where the device is envisaged to be sold; and
— the instructions for use in the languages accepted in the Member States where the device is envisaged to be sold.”[2]
In brief, the Member State where a device is going to be marketed may require that the manufacturer present the label and the Instructions for Use (IFU) of the medical device in one of the official languages of that State.
Moreover, as we can see, the new Regulation gives special attention to ensuring that users can unequivocally comprehend the product packaging.
Authorised representative
· If the manufacturer is not established in a Member State, a sole authorised representative will be designated for placing the device on the Union market. In these cases, the authorised representative is obligated to provide, upon request from a competent authority, the necessary information and documentation for demonstrating the conformity of the device “in an official Union language determined by the Member State concerned” (Article 11, section 3, paragraph d).
· Furthermore, Article 16 sets forth that distributors and importers can also have document and management obligations, according to which the information must be translated into the language of choice of the Member State where the device is marketed. That translation must be “accurate and up-to-date” (Article 16, section 3). Translated labels and instructions for use must be provided to the manufacturer and the competent authority together with a sample or mock-up of a device before it is marketed (Article 16, section 4).
In general, the manufacturer is liable for a device, including the accompanying documentation.
EU declaration of conformity
- The same linguistic obligations apply to the EU declaration of conformity, which states that a device complies with the requirements set forth in the Regulation: the declaration of conformity shall be translated into an official Union language or languages required by the Member State in which the device is made available (Article 19, section 1).
Conformity assessment
- As it is explained in Article 38, conformity assessment bodies shall submit an application for designation to the authority responsible for notified bodies. All related documents (including technical documentation and audit, assessment and inspection reports) shall be made available in an official Union language(s) determined by the Member State in question. If the Member State does not require a specific language, those documents shall be available in any official Union language.
- This also applies to certificates of conformity (Article 56, section 1).
In brief, the MDR requires that written documentation and communications between the participants in all the necessary stages for the marketing of medical devices in the EU must be in the language determined by the Member State.
In addition to the labelling and the IFU, this documentation includes validation tests or studies, descriptions, technical specifications, commercial documentation, etc.
Other relevant aspects of the new Regulations
Unique Device Identifier (UDI system)
- As we mentioned, the new Regulations seek to facilitate the traceability of all devices marketed in the Union. They must be marked with a Unique Device Identifier (UDI) on the label or packaging. The UDI of devices must be registered and indexed in the EU’s central database: EUDAMED.
Quality management system
- Manufacturers must also establish, implement and create documentation within a quality management system (QMS).
Conclusions
As we can see, the new MDR 2017/745/EU continuously specifies the need for devices to be accompanied by documentation in the appropriate language. Language is the key to ensuring that a medical device is correctly and safely used by a patient or operator.
Based on the specifications of the Regulation, and despite the fact that Member States are not obligated to require that documents be translated into one of their official languages, it is understood that they will do so, precisely to ensure compliance with the Regulation regarding comprehensibility of the medical device.
Manufacturers must therefore be prepared to translate all types of documentation into any of the 24 official languages of the EU.
And especially from now on, manufacturers must be particularly careful about translating all technical documentation, which must be provided to the notified bodies. In this regard, the Forum of Notified Bodies Medical Devices (NB-MED) has presented Recommendation NB-MED/2.5.1 on the Translation Procedure: it establishes that the translation of instructions for use must be “exact”, thereby inferring that manufacturers are in charge of ensuring that a reliable and quality translation process is followed.
At Siens Translation, we recommend that whenever you have to translate the documentation specified in MDR 2017/745/EU and IVDR 2017/746/EU, you order the work from a translation agency that:
- has specialised medical translators who are familiar with the new Regulations, and
- holds ISO certification in quality management.
A quality translation into any of the required languages will ensure the safety and proper use of your medical devices and will help you to comply with the new Regulations of the European Union.
[1,2] REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC < https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=ES#d1e32-94-1 > [Accessed: 26/02/2021]