Latest releases - MDCG Guidances from DOC ROOM EUROPE
Dear Members,
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Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last May and June 2020, regarding subjects you might find of interest.
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May 2020
MDCG 2020-11 - Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission (…)
Most recent articles
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MDCG Guidances releases
15 June 2020, by MME -
In Vitro Diagnostic Medical Devices
15 June 2020, by MME, Rene ClementIn order to give flexibility to the IVD manufacturers for a progressive introduction of their product lines into the European Market, the fee structure is constituted of an annual administrative fee and a “per product designation fee” which will be invoiced only at the date of their notification to the concerned European Competent Authorities and only for the part of the year remaining to the next anniversary date of the contract. They will be then added to the annual administrative fee (…)
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Searching for a NANDO designated NB ?
27 May 2020, by MMENANDO is publishing a list of NBs designated for MDR and IVDR auditing.
Lists are available from EUROPA (GROWTH) website and permanently updated. Here below are the useful e-address where to start your researches.
NANDO is publishing a list of NBs designated for MDR and IVDR
(with or without "restrictions" in their fields)
MDR list is available from https://ec.europa.eu/growth/tools-d...
Clicking on one the 14 (on May 27 2020) existing NB, you’ll access to their contact (…) -
May 19, 2020 - Official Journal of the European Union
27 May 2020, by MMEOfficial Journal of the European Union 2020 | C 171 | 1 May 19, 2020
COMMUNICATION FROM THE COMMISSION Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of Regulation (EU) 2017/745 (2020/C 171/01)
Integral article of the Official Journal of the European Union, dated May 19th, 2020
COMMUNICATION FROM THE COMMISSION
Guidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of (…) -
May 2020 - 17th Notify Body designated by NANDO
27 May 2020, by MMEMay 2020 - 17th Notify Body designated by NANDO
MDR : 14 Notified Bodies
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Specific fields for accredition can be found on NANDO website (hlm and PDF are available) : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
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NB 0086 BSI Assurance UK Ltd United Kingdom
NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 2409 CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító (…) -
Mid April 2020 - MDCG Guidances release
8 May 2020, by MMEApril 15 - MDCG Guidances
Dear Members,
Here are thereafter and attached in PDF format four MDCG (not binding) guidances released last mid April regarding subjects you might find of interest.
2020-04-23 05 MDCG 2020-5 Guidance on Clinical Evaluation - Equivalence available from https://ec.europa.eu/docsroom/docum...
2020-04-23 06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices available from https://ec.europa.eu/docsroom/docum...
2020-04-24 MDCG (…) -
April 17th EU parliament voting MDR postponing
17 April 2020, by MMEMDR 2017/745 postponed till May 2021
Dear Partners,
You will share with us the news available from https://www.europarl.europa.eu/plen... that confirms proposal C9-0098-2020 (Medical Devices) has been approved by :
693 votes "YES"
2 abstentions
1 vote "NO’.
MDR and some of its requirements are so postponed for a year.
We’ll know detail when it is published in JOUE, but shall try to keep you updated the best we can till then.
Best regards,
MME team -
March 2020 - NANDO designated NBs MDR-IVDR
31 March 2020, by MMEMarch 2020 Update of the list of Notified Bodies accredited by NANDO for MDR and IVDR
MDR : 12 Notified Bodies
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Specific fields for accredition can be found on NANDO website (hlm and PDF are available) : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34
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NB 0086 BSI Assurance UK Ltd United Kingdom
NB 2797 BSI Group The Netherlands B.V. Netherlands
NB 2409 CE Certiso Orvos- és (…) -
2020-02- NANDO NBs Update - NSAI 0050
13 March 2020, by MMEDesignation by NANDO of NSAI as MDR NB
Source : https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=EPOS_43372
National Standards Authority of Ireland (NSAI)
1 Swift Square, Northwood, Santry
Dublin 9
Country : Ireland
Phone : +353.1.807.38.00
Fax : +353.1.807.39.25
Email : info@nsai.ie
Website : www.nsai.ie
Notified Body number : 0050
is designated as 11th NB by NANDO for MD under MDR 2017/745. -
2020-02-06 NBs Update - NANDO and MDR-IVDR NBs
7 February 2020, by MMEDNV GL Presafe (2460), Norway is notified by NANDO to MDR 2017/745
DNV GL Presafe (2460) in Norway is the 10th notified body certified to the MDR 2017/745.
DNV GL Presafe AS in Norway was notified according to Regulation (EU) 2017/745 (MDR) on February 6, 2020.
_ The publication on the European Commission’s "NANDO" site is accessible via this link. https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&body_type=NB&refe_cd=NANDO_INPUT_215008 (…)