Question

(f) Point out any two prospects of the MWDR.​

Answer 1

Answer:

In general the MDR applies only from 26 May 2021 (Article 123(2))

The MDD and AIMD will not be repealed until 26 May 2021, with the exception of vigilance requirements, the keeping of records and the exceptions mentioned in the article (Article 122)

Manufacturers and notified bodies wishing to obtain certification or notification under the MDR now may do so earlier - and earlier in this case means before 26 May 2021 (Article 120 (5) and (6))

Voidance of all notifications of notified bodies under the MDD or AIMD only by 26 May 2021 (Article 120 (1))

postponing until 26 May 2021 the adoption of the common specifications and their application from the same date, if determined in accordance with Article 9, for products without an intended medical purpose listed in Annex XVI (Articles 1, 17)

reprocessing only of single-use products placed on the market until 26 May 2021 and not May 2020 in accordance with Directive 93/42 EEC or after that date in accordance with MDR (Article 17)

Publication of the notice on the functionality of the EUDAMED database and the EU Commission's compliance with the associated deadlines postponed to 25 March 2021 (Article 34)

Answer 2

Answer:

adoption and bootle necks are futher prospects of the MWDR

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