Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) states that devices which have a valid certificate issued by a Notified Body under the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR, under certain conditions and no later than 26 May 2024.

These conditions imply the following:

• NO significant changes in the design and intended purpose of a device must be made after the date of application of the MDR – expected on 26 May 2021;

• in case of changes that are not significant with regard to design or intended purpose, the required surveillance or documental assessment MUST be carried out by the Notified Body that issued the certificate.

WHAT MANUFACTURERS MUST DO

Manufacturers must adjust their change notification procedures, in accordance with the principles outlined in MDR Art. 120. The adjusted procedures will be subject to notified body assessment within their surveillance activities according to MDR Art. 120(3).

It is important to highlight that no issuing of new MDD certificates, including modified, amended or supplemented certificates, is allowed under MDR Article 120(3).

If the manufacturer wishes to make a “significant change in design or intended purpose” under MDR Article 120(3), the implementation of such a change would prevent the manufacturer from continuing to place that device on the market under the Directives.

In line with agreed arrangements for notification of changes between the manufacturer and the notified body according to the MDD (e.g. accepted regulation, approved procedures) changes and their implementation will be verified by the notified body as part of the surveillance activities, or following a manufacturer’s submission for prior approval. The outcome of this verification will determine whether a certificate in accordance with MDD remains valid according to Article 120 MDR.

ATTENTION! Manufacturers are NOT allowed to make significant changes in design or in the intended purpose. Hence, all the changes must be communicated to the Notified Body before their implementation, that will determine whether the changes are significant.

For more information, please contact our Sales Manager:

Antonio Balassone email antonio@entecerma.it | mob. (+39) 393 2471040