Transition of Notified Body from NB0434 and NB0470 to DNV GL Nemko Presafe NB2460

DNV GL Business Assurance Norway AS NB 0434 ceased to operate in May 2017 and so did Nemko AS NB 0470 in April 2017. Both aforementioned Bodies were operating as a joint venture which merged with the aim of transitioning their departments under one new legal entity and because of the mandatory renewal of designation for all Notified Bodies under the new Medical Devices Regulation MDR 2017/745.

The new unified NB 2460

The result of the merger between the two NBs is the creation of DNV GL Nemko Presafe NB 2460. The new NB 2460 has started operating and issuing certificates since March 2017. Accordingly, any of the Manufacturers that were previously certified with NB 0434 and NB 0470 will need to complete the process of transferring all valid certificates to the new NB 2460 until 17th of November 2017.

Recommendations for Manufacturers working with the unified NB

There are certainly numerous consequences of the merger for the Manufacturers, especially for those having ongoing medical notification and/or registration procedures. In order to avoid interrupting or delaying those regulatory procedures and receiving additional requests from Competent Authorities, it is highly recommendable for every Manufacturer certified by NB 0434 or NB 0470 to inform all the Authorities involved in the process of the transfer agreement coming into effect.

Obelis at Your Service

In such cases, it is extremely important to rely on competent and experienced personnel which will provide you with all the available options, even helping you select a Notified Body with our NB Selection service.

If you wish to know more about regulatory issues under EU Law, please do not hesitate to contact us. Obelis Expert Consultants, having nearly 30 years of experience with EU Regulations, will answer any question you may have and will gladly assist you in the process of choosing a suitable Notified Body.

Alessandro Polimeno

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