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.
