Scribd Logo
Upload

Welcome to Scribd!

  • Tuyên bố hiệu lực của CE đến 2028 - Công chứng

    Uploaded by

    manh.dang
    4 views5 pages

    Original Title

    Tuyên bố hiệu lực của CE đến 2028_Công chứng

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    4 views5 pages

    Tuyên bố hiệu lực của CE đến 2028 - Công chứng

    Uploaded by

    manh.dang

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
    Flag for inappropriate content
    of 5
    Eee TRANSLATION BAN ICH & PROTEC OTE Oni xn Dt e712 Cet nore mate KG anh ust Sorv9e) 70090380 Fax 505860 Mal: pecs om Ia wpe inh gi ee Kish gi dit PROTEC, ‘Ching 1 xn thing bo 16 cu Hh rng i do qu rsh chuyén dBi MDD sang MDR ti thing 3 nim 323 theo Quy inh ea EU 2023/07, nen vin 88 vb sy rng eth ny sin ong qu ind rao ie ‘hing nh vl ed cng, HMch hing eco quan eth quyen i nue tb. ‘Di wie sin phim vin cb ching nha MDD, thy thule volo iro, th tng chim nn nly cho ‘Sn nly 31 thing 12 nim 238. VL do chin hi pp, hi an iu lve de ch inh én ching ch MDD sf King duos gia hanna. Do 6, ki nip Kau mt sin phim Lign minh Chiu A, 6 ht iby ‘hig aa 2 han, med gi php cin nb vn cn Bu ‘Sin pl eta PROTEC I sh pli lo Ib vi fp dng cho los ny. Sn phim fp ye 6 mgt ee chu do MDD tra vi inp nay ci ny ig etn cing nn iy chuda Chi Au bt a as > =e = rasa Di ‘in Te an uo chng hn PROTEC Neiy het han di kién ela ching nhén IA ngly 11 thing 10 nim 2023 461 véi CONAXX 2, PROPAXX, RAPIXX vit cd cic ma hang eda PRS 500, tuy nhign, thye & Gify hig nhin vin ‘dn hu le cho én ngay 3 ding 12:nfm 2028, nhu duge m0 186 ten = == 26 Do 6 ching nhn MDD vin cin hig le quy khich ing 8 tim thy thém thong tin vé vin my tnén 1 thing tn sau dy cla Lign minh Chiu Au: Updated -Fagisheet for authorities in non-EUIEA stas on in vito diagnostic medial dev Do ching t6i dang trong gsi dogn kiém tra va chuyéa dBi ti MDD sang MDR nn ching ta dr kin sf nhn duge ching nhin MDR cho cic sin phim cia minh vio nim 2024. Vin 8 tif in dupe mo 1d truge day vi nhamg diéw khng chic chin véhigu lye cba ehimg nhén MDD sf e6 te ng dn ching t6 vi quy Khdch vit céch nha phn phi, chi tong mt thoi gianna (Ching ti sin sing xii ru guy Khdch o6 bt kc hi hoe in xt no v8 vin 48 nly hoe ec vin dB ke, ‘Oberstenfld, my 06.10.2023 (Day va ting ain) Fabian eidrch Gi abe kinh doanh PROTEC GmbH & Co. KG $ / wee cee comm St Ge GD Sarena — icper mesos: — Stemttraneeno mere XACNHAN CUA CONG TY ‘TNH DICH THUAT PTL Tei, Nguyfa Neve Huyén, MND sé: Xée-nhn bil Nguyen Ngoc Huyén, CMND_ sé: (001195012671, ep ngdy 20/07/2021, tai Cue 001195012471, cép npiy 2007/2021, tat Cue ein sik cin sit Quin Ij Hinh ehish vé Trt ty X& hoi, Quin Ij Hin chinh vé Tritt X@ hi, nn vién ein ‘eam doan da dich chin x, phi hop ni dung vin Cng ty TNHH Dich thugt PTI di cam doan dich diy Thin dinh kam téng Anan iéng Viet vi chi xe ni dng vin bin ih km, Ti Cn sy TNAH jeh thst PTL ‘Ny 09 hing 10 nim 2023 “Ngity 09 thang 10 nam 2023. THAY MAT CONG TY NGUOI DICH GLAM DOC Nauyda NeocHuyén 3 at PROUEG ean |seour|ABLTY ROT Gn a nD 0.7172 ar tronic om cos taba 70 obs Teor 0 0708-32550 ‘Towhom i may concirn i" anaes Fata don tee Sono neon Dear PROTEC partner, ‘We would Ike to inform you proactively that in the context of he extension of the transition periods from MDD to MDR from March 2023 wit the EU Regulation 20231607, a potential problem of understanding may arise during the exchange of Cettfcates with companies, customers, of authors fom third count For products tha sll have an MDD certificate, depending onthe risk cass itis possible {0 use this cerifcate unt 31 December 2028. For formal and legal easons, the valcty periods specified on the MDD certfcates wil n longer be extended. Therefore, when importing a product from the European Union, itmay appear that a certificate has already expired, although its legal validly continues, PROTEC's products ae class llb products and apply to this category. They continue to meet al requirements set by the MDD and are val, even if the validity date onthe ‘certificate appears to have expired: ‘Beye oncecte [Atal legal expiry date of certificate ed we: ey pido OTE fet, “The supposed expraton date ofthe certificate is dated 11 October 2023 for CONAXX 2, PROPAXK, RAPIXX and forthe PRS 500 series - however, the certificate {s valid unt 34 December 2028, as described before smucorseammson CHA pein a momen EB eugene ‘The MOD certificates are therefore sil valid - you wil also find further information on | this on the following fetsheet ofthe European Union: a ‘As we are inthe audit and transtoning phase from MDD fo MDR, we expect fo receive the MOR certfcates for our products In 2026, The previously described potential issue vith uncertainies about the valty of MDD certificates will afect us, nd you as a

    You might also like