MDR Language Requirements in Greece

All MedTech companies are facing new challenges since the Medical Device Regulation MDR (EU) 2017/745 has become effective in 2021. A key aspect of distributing your medical devices in the European Union is the translation of all product information. If you want to sell your products in Greece you may not be sure what your real translation needs are, but let us help you to understand the legislative framework and determine general translation guidelines for Greece.

In Greece the Official Gazette 2198/B/2-10-2009 to harmonize the national legislation with the Directive 93/42/EEC (Medical Devices Directive, MDD), is the only legislation in Greece so far.

There have not been updates on a new national implementation of the 2017/745 MDR. According to the National Organization for Medicines (EOF), which is the Legal Entity under Public Law of the Ministry of Health, defines the Gazette 2198B/02-10-2009, among others, as “applicable legislation” in addition to the regulation (EU) 2017/745. So, let’s dive into the language requirements for medical devices in Greece!

Language Requirements for Labeling and Instructions for Use (IFUs)

According to the Gazette from 2009 the information intended for patients or end user must be provided in Greek.

“The information that must be available to the user and the patient according to Annex I point 13, must be complete and accurate in the Greek language, when delivered to the end user, whether it is for professional use or otherwise.” – Art. 4(4), Official Gazette 2198/B/2-10-2009

However, there might be exceptions. For example, if the medical device is intended only for healthcare professionals, the IFU as well as labelling can be provided in English. As specified, there is no possibility to provide this information in another EU language according to Greek legislation.

“The EOF may, in derogation of the provisions of this decision, decide on a case-by-case basis, for products intended exclusively for professional use, the exemption from the mandatory use of the Greek language […], taking into account the principle of proportionality and in particular the possibility of indicating the said indications through harmonized or recognized symbols or other measures, as well as the intended type of use of the product. In this case, it is mandatory to write this information in English.” – Art. 4(4), Official Gazette 2198/B/2-10-2009

We can remember that similar to Germany, Greece has different language requirements for the professional user or the lay person user as for the languages accepted.

Language Requirements for the EU Declaration of Conformity

The DoC is a formal declaration that the medical device complies with the relevant EU regulations and has undergone the required conformity assessment procedures. The declaration serves as proof of compliance and is required for the device to be placed on the market and sold within the European Union, including Greece. This document must be presented to the competent authority, which in Greece is the EOF.

According to Article 19.1 of the EU-MDR, the manufacturer is responsible for the correctness, completeness and accuracy of the information in the DoC and should be provided in an  EU-Member State language. The EOF has published a model Declaration in Greek, which manufacturers can use. 

Click here to access the DoC model from the EOF in accordance with (EU) 2017/745 in Greek and be on the safe side.

Language Requirements for the Implant Card

Every patient who has had an implantable product implanted after an operation receives an implant card. It is the obligation of the medical device manufacturer to provide this document to the patient in a legible and easily understandable form.

As for the EU 2017/745 the EU-MDR states that the contact information of the manufacturer must be included to ensure patient safety. Since this is “that must be available to the user and patient”, in Greece the implant card must be provided in the national language, Greek.

Language Requirements for the Field Safety Notice

According to Article 6 of the general vigilance requirements published by the EOF, the Field Safety Notice as well as corrective actions must be sent out to all customers and users in Greek. 

This publication is from 2010, but since there has not been any amendment of this legislation, it is still in force and applicable for the implementation of the EU-MDR.

Conclusion

Although Greece has yet to update its legislation to comply with the EU Medical Device Regulation, medical device manufacturers who wish to market their products in Greece are still required to comply with the language requirements specified in the Official Gazette 2198/B/2-10-2009.These requirements apply to all necessary information related to the device, including the EU Declaration of Conformity, implant card, and field safety notice. The language used must be in Greek, as it is the official language of the country.

Manufacturers, distributors and importers are strongly encouraged to use a certified translation company with quality standards such as ISO 9001, ISO 17100, and ISO 13485 to ensure accurate translations for your medical devices.