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    Meril Life_Transfer Agreement

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    Meril Life - Transfer Agreement

    Uploaded by

    vlas.ion

    Copyright:

    © All Rights Reserved
    Download as PDF or read online from Scribd
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    of 15
    TRANSFER AGREEMENT FOR SURVEILLANCE OF MDD LEGACY DEVICES specifying the terms of the transfer of the appropriate surveillance activities according to Article 120 Ge) of Regulation (EU) 2017/745' in respect of legacy devices covered by a certificate issued in ac- cordance with Directive 80/385/EEC or Directive 93/42/EEC The Company Company: Meril Life Sciences Pvt. Ltd, Name and legal form Adress: Muktanand Marg, Chala, Street, house number Vapi-396191 Zip code, city Gujarat Country India Single Registration number (SRN): IN-IMF-000008308 (occ, to Artikel 31) Contact person: Mr. Narendra Patel Title, first name, last name General Manager QA & RA Telephone / Fax: +91 0260 240 8000 EM: Narendra Patel@merilife.cor ~ hereinafter referred to as “CERTIFICATION HOLDER’ -, the notified ody with the identification number: 0297 DQS Medizinprodukte GmbH ‘August-Schanz-StraBe 21 60433 Frankfurt am Main Germany hereinafter referred to as “INCOMING NB" - and the notified body with the identification number: 1783 ‘TURKISH STANDARDS INSTITUTION Necatibey Cad, No.:112 Bakanliklar-ANKARA, TURKEY ~ hereinafter referred to as “OUTGOING NB’ - have concluded the following Agreement under the TRANSFER DATE effective on 2024-02-08: "As amended by Regulation (E) 2023/57 of the European Parament and ofthe Counc of 15 March 223 420_55e_Transfer Agreement MDD legacy devices Version: 1.0 TRANSFER AGREEMENT FOR SURVEILLANCE OF MDD LEGACY DEVICES S 51 Scope 1. CERTIFICATION HOLDER underwent conformity assessment activities and holds certification issued iby OUTGOING NB in accordance with Directive 90/385/EEC or Directive 93/42/EEC that is valid or to be considered to be valid by virtue of paragraph 2 of Article 120 Regulation (EU) 2017/745 cov- ering a device which is placed on the market after date of application of the Regulation (EU) 2017/745 until the date set out in paragraph 32 of Article 120 of this Regulation {hereinafter re- ferred to as “legacy device”) that is subject to appropriate surveillance activities in respect of the applicable requirements according to Article 120 (3e) of Regulation (EU) 2017/745 (hereinafter re- ferred to as “appropriate surveillance’), and intends that this approprete surveillance in respect of that legacy device are in future carried out by the INCOMING NB, Appropriate surveillance’ can in- clude for example documentation review, audits or other kinds of assessments performed by a no: ‘ified body in respect of a legacy device (Gee ¥6 (T)) as part of CERTIFICATION HOTDER'S previous conformity assessment procedure under Directive 90/385/EEC or Directive 93/42/EEC. Certification is a valid confirmation in the form of a certification document, in accordance with one of these Di- rectives, that conformity assessment activities have been completed successfully and can be sup- plemented by written confirmations issued by OUTGOING NB * 2. The legacy devices that the OUTGOING NB issued a certification for and which are subject to —— wansferrec-appropriate surveillance to the INCOMING NB (herennatter referred to as tegacy deur «es subject to transfer of appropriate surveillance”), and the agreed date on which any review activi- ties by the INCOMING NB in accordance with § 4 are to be completed and from which any surveil lance activities by the INCOMING NB are to be carried out and the responsibility for the appropri- ate surveillance assumed by INCOMING NB (hereinafter referred to as “TRANSFER DATE"), are specified in Appendix 1, The TRANSFER DATE shall not exceed 26 September 2024 3. Appropriate surveillance may be transferred only in respect of a legacy device for as long as itis included in the scope of a certification considered as valid in accordance with Article 120 para- Z graph 2 OF Regulation (€U) 2017/745 and issued by att OUTGOING NB covered with the respective designation/notification valid at the time when this certification was issued. Certification, which is suspended or temporarily restricted for the relevant legacy device may not be accepted for transfer of appropriate surveillance in respect of that device, but itis up to the IN- COMING NB's decision and subject to the assessment prior to transfer in accordance with § 4 Certification, which is withdrawn or otherwise invalidated prior to TRANSFER DATE is not subject to transfer of appropriate surveillance in respect of that device ‘As pec MOCG 2021-25 (Regulation (EU) 2017/748- application of MOR requirments to ‘legacy levies an to devices placed ‘nthe matket prior to 26 May 2121 in accordance with Directives 90/3B5/EEC oF 93/42/EEC (Gctober 2020) 'As per MDCG 2022-4 rev.1 (Guidance on appropriate surveillance regaaing the fanstional provisions under Article 120 othe MOR regarding devices covered by certificates acording to the MOD or the AIMDD (Decembe 2022} ‘ramples of suvellance aces (non-exhaustive = OMS audits focused ais fg, steriiation, microbiology, supplier etc) unannounced audits for cause aus change notifiation assessment eg, changes which ae consideved not tobe sigifcant as per Art. 1203, = vigilance having + appeals complaints authority notes fog CEFs, lassifeation Asputesdeisions) ~ cantificate actions. withdraval, suspension, re-nstatement, cancellations hotfiation to ational authontes * recording to section 4 of MOCG 2020-3 rev, 1

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