MDR Language Requirements in Germany

The EU-MDR has been active since 26 May 2021. It applies to all medical devices sold or distributed within the European Union and affects all MedTech companies. 

Germany has specific laws for medical device manufacturers and distributors to follow. These laws include language requirements.

In Germany, the MPG (Medizinproduktgesetz) was the official regulatory law for medical devices in Germany for many years. The MPDG (Medizinproduktedurchführungsgesetz) replaced the MPG as transitional act (from MPG to EU-MDR). Both have been replaced by the new MPEUAnpG (Medizinprodukte-EU-Anpassungsgesetz – MPEUAnpG), which was implemented for the national adaptation of the MDR 2017/745 and IVDR 2017/746. 
 

Language Requirements for Labeling and Instructions for Use (IFUs)

In Article 8 of the new Medical Devices EU Adaptation Act ( MPEUAnpG) requires medical device manufacturers to provide German language labels and instructions for use in order to be used in Germany. This requirement applies to all medical devices, regardless of whether they are manufactured in Germany or imported from another country.

The only exception is for medical devices intended for use only by healthcare professionals. In such cases, the labeling and IFUs may be provided in another language than German.

"[...] if this information is intended exclusively for professional users and the safety-related information is also provided in German or in the language of the user." - §8 (2), MPEUAnpG

The labeling and instructions for use of the device can be provided in the language of the destination country if the device is only meant for export outside the EEC. In such cases, the language(s) of the country of destination must be clearly stated in the free sales certificate.

Language Requirements for the EU Declaration of Conformity

The Declaration of Conformity must be translated into an official language of each European Union Member State in which the device is made available, as per the requirements of the European Union Medical Device Regulation (EU-MDR). 

The Declaration of Conformity is an assurance that the device meets all necessary regulatory requirements. This document is essential for the device to be legally sold in the European Union. 

In Germany, manufacturers must provide a declaration of conformity in German or in English.

"The manufacturer shall, for devices made available on the market within the scope of this Act, provide the EU declaration of conformity in accordance with Article 19(1) of Regulation (EU) 2017/745 in German or in English." - §8 (1), MPEUAnpG

This also applies to devices marketed in other EU member states. The declaration must be provided in at least one EU official language.

Language Requirements for the Implant Card

The manufacturer must provide the patient with an implant card (IC). The IC contains information about the implanted device, such as the device name, serial number, and lot number. It also includes the manufacturer's name, address, and website. 

According to the German MPEUAnpG, the information on the IC must be provided in German. This is to ensure patients have access to all necessary information about their implanted device. Healthcare professionals can then take appropriate measures in emergency situations.

"The manufacturer of an implantable device shall provide the information referred to in the first subparagraph of Article 18(1) of Regulation (EU) 2017/745 in German." - §8 (3), MPEUAnpG

Language Requirements for the Field Safety Notice

The field safety notice (FSN) is a communication that manufacturers must send out in the event of a safety risk related to their medical device. The FSN provides details about the corrective actions that users should take. According to the German MPEUAnpG, the FSN must be provided only in German. This ensures that the communication is clear and understandable to German lay and professional users.

"Where manufacturers take safety corrective measures within the scope of this Act, the safety instructions in the box referred to in Article 89(8) of Regulation (EU) 2017/745 shall be written in German." - §73 (1), MPEUAnpG

And what about Notified Bodies in Germany?

Notified bodies are organizations designated by EU member states to assess the conformity of medical devices with the requirements of the EU-Medical Device regulation. In Germany, notified bodies are designated by the Federal Institute for Drugs and Medical Devices (BfArM) according to the requirements set out in the MPEUAnpG, MPDG and MPG.

Notified bodies must be accredited by the German Accreditation Body (DAkkS). Any updates on accredited Notified Bodies will be published by Central Authority of the Laender for Health Protection (ZLG). The governmental bodies check if the NBs meet certain requirements, including having a quality management system in place that complies with the relevant EU and German standards.

In addition, they must have personnel who are competent and possess the necessary expertise to assess the conformity of medical devices. Notified bodies have an important role. They ensure that medical devices marketed in Germany comply with regulations and standards. This gives patients and healthcare professionals confidence in the safety and effectiveness of these devices.

Responsibility for Compliance with Language Requirements

Manufacturers, distributors, and importers are responsible for ensuring that their medical devices comply with the language requirements set out in the MPEUAnpG and the EU-MDR in Germany. The medical company must have a quality management system in place. 

This system must be well-defined and documented. It should include procedures for verifying and validating information. This ensures all information is accurate and up-to-date. 

This system should be regularly reviewed and updated to ensure that it meets the company's current needs and industry standards. 

Additionally, it should include specific procedures for selecting a translation provider specialized in medical device translation in Germany. The translations must be accurate and comply with the language requirements set by the MPEUAnpG and the EU-MDR.

To ensure high-quality translation, it is recommended that manufacturers use professional translation services that specialize in the translation of medical devices.

Conclusion

The EU-MDR has brought about new language requirements for medical devices sold or distributed in the EU member states, including Germany. The German Medical Devices EU Adaptation Act, sets out specific language requirements for labeling and instructions for use (IFUs), the EU declaration of conformity, the implant card, FSN and all stakeholders. 

If you are going to translate your medical device documentation, you should use a professional translation company that is ISO 13485-certified. This is especially recommended if you want to market a class III medical device in Germany. This specialized language service for medical device industries is crucial to guarantee patient safety.