MDCG 2019-10 Article 120 Guidance
The guidance document for the implementation of Article 120, which many companies plan to use during the transition to MDR EU 2017/745, has been published.
The main requirements for the validity of the 93/42/EEC and 90/385/EEC certificates after May 2021 can be summarised as;
- No significant changes on the device design
- Implementation of the MDR requirements related to post-market surveillance, market surveillance, vigilance, registration of economic operator by the manufacturer
The guidance includes a paragraph about the surveillance audit rights of the Notified Bodies during this transitional period.
“In order to allow manufacturers to take advantage of Art. 120(2) and Art. 120(3) of the MDR, it needs to be ensured that Authorities responsible for notified bodies have the right to and do monitor those notified body’s activities to the extent appropriate and necessary. For this purpose, Article 120(3) and Article 122(1) of the MDR provide the necessary legal basis for Member States to establish the necessary legal empowerments by means of National law to carry out the needed monitoring activities in relation to Notified Bodies. All this is regardless of whether the Notified Body has applied or not to be designated under the MDR and/or it has a still valid designation under the Directives during the validity of certificates issued in accordance to the Directives.”
You can download the full text of MDCG 2019-10 from this link.1