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July 2019 - More about NBs

2019-07-15 - More about Notified Bodies out or in the run for MD/IVDR...

2019-07-15 - More about Notified “Bodies

• Austria: lost all its ONs last year, but a new one has been created, Quality Medical Devices (QMD), being notified for MDR, the IVDR to follow

• Spain: AEMPS (NB0318) , a single Spanish ON, filed its MDR case

• United Kingdom:

UL International (UK) Ltd. (NB 0843) announced the termination of its ON MDR activities. They will continue under a unique NBOG code IVD 0308 (trisomy 21 only, including software).

UL has nevertheless established a partnership with POLSKIE CENTRUM BADAN I CERTYFIKACJI SA (PCBC, NB 1434, Poland) thus allowing the transfer of CE certificates.

LLOYD’S REGISTER QUALITY ASSURANCE (LRQA) (UK) Ltd . (NB 0843) announced the discontinuation of its MDD (93/42 / EEC) and IVDD (98/79 / EC) activities. It also withdraws their application to become a Netherlands-based ON, and will not apply to become ON MDR or IVDR.

• Switzerland – QS Zürich AG’s NB 1254 - will not apply to be ON on DM- nor DIV

DEKRA & IMQ have received a positive MDR opinion, both of which are non-applicants to the IVDR.

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