MDR: The Registration Phase (4/6)
EU declaration of conformity
Once you have received your SRN, you can prepare and submit the EU declaration of conformity according to instructions stated in article 19 and Annex IV. The MDR specifies that the declaration of conformity will have to be regularly updated as well as its translation(s), therefore keep it as part of your post-market surveillance files:
"The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available."
If the device doesn’t require the involvement of a Notified Body for conformity assessment, all the steps necessary to begin marketing the device have now been completed.
Conformity assessment procedures
If the device is subject to conformity assessment procedure(s) involving a notified body, the next steps will be:
- choosing a NB according to the device’s classification,
- preparing your application(s) according to the assessment(s) your are applying for.
Different conformity assessment procedures apply according to the class the device has been assigned to. Keep in mind that the Member State in which the notified body is established may require that all or certain documents, including the technical documentation, audit, assessment and inspection reports, relating to the conformity assessment procedures (referred to in paragraphs 1 to 7 and 9 to 11 of chapter V section 2) be made available in an official Union language(s) determined by that Member State. In the absence of such requirement, those documents will have to be available in any official Union language acceptable to the Notified Body. (article 52)
On completion of the assessment(s), the Notified Body will issue it(s) certificate(s) in an official Union language determined by the Member State in which the notified body is established or otherwise in an official Union language on which the NB agrees on.
You will receive one certificate per conformity assessment procedure (Annex XII)
The certificates are valid for the period indicated by the notified bodies, with a maximum of five years. (article 56)
Summary of safety and clinical performance (SSCP)
For implantable devices as well as class III devices (other than custom-made or investigational devices) an additional document is required for submission to the notified body involved in the conformity assessment : The summary of safety and clinical performance. Article 32 states that "The summary of safety and clinical performance shall be written in a way that is clear to the intended user and, if relevant, to the patient (…)"
The Medical Device Coordination Group shares more details in its "guide for manufacturers and notified bodies" regarding the translations of the SSCP. According to them, the Manufacturer will submit the SSCP to the NB in one language accepted by the NB and agreed with the manufacturer, and this will be the "master" SSCP, validated and uploaded by the NB to EUNAMED. The manufacturer will have to mention on the label or instructions for use where the summary is available. (article 32)
Once the "master" is uploaded in EUNAMED, the manufacturer will be responsible for translating the SSCP into each language required by each member state concerned. Each SSCP document (that is to say each translation) should state in which language the SSCP was validated. Furthermore, THE MDCG states that English being the most common language used in medical scientific publications and being understood by many healthcare professionals in the EU, providing an English-language version of the SSCP will enhance access to information.
Therefore, if the "master" SSCP is in a language other than English, an English translation should be provided by the manufacturer within 90 days of the upload of the "master" SSCP. The NB should upload the English translation within 15 days of receiving this from the manufacturer. Since only the "master" will be validated by the NB, the manufacturer should ensure, through its quality management system, that the translations are correct.
In other words, if you are planning to address several markets and Member States, the registration process will entail a bit of translation work. Be sure to select the partner you feel confident to entrust your documentation to.
Pricing is often in the top criteria, for the registration of your device, expertise and failsafe processes should be too.
Contact us today for more information on how Baguette can help you work it all out.