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Výrobky pro kontakt s potravinami - Stanovení minerálních olejů MOSH a MOAH v obalových materiálech:

Vzhledem k opakovaným požadavkům klientů byla v laboratořích ITC vyvinuta nová metoda - Stanovení minerálních olejů MOSH a MOAH v obalových materiálech. Aromatické minerální oleje (MOAH) jsou dle EFSA považovány za potenciálně karcinogenní a je jim věnována zvýšená pozornost. Migrační limity byly zatím stanoveny pouze na národní úrovni Federálním úřadem Německa pro hodnocení zdravotních rizik (BfR).
Bližší informace: Laboratoř analytické chemie; fpuype@itczlin.cz ; analyt@itczlin.cz


Ing. Taťána Pašiaková

V hlubokém zármutku oznamujeme, že nás náhle opustila naše drahá kolegyně Ing. Taťána Pašiaková. S hlubokou úctou k památce zesnulé - pracovní kolektiv ITC Zlín.


Měření fyziologických vlastností textilií

ITC rozšířil seznam akreditovaných metod o zkoušku podle ČSN EN ISO 11092 - Textilie - Fyziologické účinky - Měření tepelného odporu a výparného odporu za stálých podmínek. Zkoušku využijí především výrobci a dovozci funkčního ošacení garantující vysoký uživatelský standard právě v oblasti fyziologických vlastností. Bližší informace získáte ve zkušebně textilních materiálů a výrobků (e-mail: textile@itczlin.cz, tel. 577 601 268).


Seminář UVÁDĚNÍ VÝROBKŮ NA TRH PODLE NOVÉHO LEGISLATIVNÍHO RÁMCE, DŮLEŽITOST NOREM PRO VOLNÝ POHYB ZBOŽÍ.

KRAJSKÁ HOSPODÁŘSKÁ KOMORA ZLÍNSKÉHO KRAJE ve spolupráci s ITC Zlín pořádá seminář UVÁDĚNÍ VÝROBKŮ NA TRH PODLE NOVÉHO LEGISLATIVNÍHO RÁMCE, DŮLEŽITOST NOREM PRO VOLNÝ POHYB ZBOŽÍ. Akce se uskuteční 04.10.2017 od 9:30 do 15:00. Přihlásit se můžete do 30. 9. 2017 e-mailem na dvorackova@khkzk.cz, telefonicky na tel.: 727 957 722 nebo přes formulář na www.khkzk.cz.


Nařízení Evropského parlamentu a Rady (EU) 2017/746 o diagnostických zdravotnických prostředcích in vitro

Dne 5. 5. 2017 bylo v Úředním věstníku Evropské Unie zveřejněno nové Nařízení Evropského parlamentu a Rady (EU) 2017/746 ze dne 5. dubna 2017 o diagnostických zdravotnických prostředcích in vitro a o zrušení směrnice 98/79/ES a rozhodnutí Komise 2010/227/EU.
Toto nařízení vstupuje v platnost dvacátým dnem po vyhlášení a použije se ode dne 26. Května 2022.


MD legislation

VOLNĚ PŘÍSTUPNÁ SEKCE 


OBSAH VOLNĚ PŘÍSTUPNÉ SEKCE:

FORMULÁŘE PRO KLIENTY

  SOUBOR Verze

Předběžný dotazník
 
2016-05-25

GFA CZ
 
2016-05-22

Žádost o posouzení shody MDD
 
2017-03-01

Žádost o posouzení shody IVDD
 
2017-03-01

Příručka pro klienty MD
 
2015-06-22

Příručka pro klienty IVDD
 
2015-06-22

COMPETENCE NB 1023

  www link FILE

Notification MDD - Nando
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=EPOS_46625
 

Notification IVDD - Nando
http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbody.notifiedbody&refe_cd=EPOS_46625  

USEFUL LINKS

  www link

EURLEX
http://eur- lex.europa.eu/en/index.htm

NANDO
http://ec.europa.eu/growth/tools-databases/nando/

European Commision – Medical Devices
http://ec.europa.eu/health/medical- devices/documents/guidelines/index_en.htm

European Medical Device Regulations
http://www.emergogroup.com/resources/reg ulations-europe

CEN (European Committee for Standardization ) - Healthcare
http://www.cen.eu/CEN/sectors/sectors/he althcare/Pages/default.aspx

Central Management Committee  (CMC) on Medical Devices
http://www.cmc-md.eu/

Notified Body Operations Group (NBOG) NBOG’s Best Practice Guide
http://www.nbog.eu/2.html

TEAM NB - The European Association for Medical devices of Notified Bodies
http://www.team-nb.org/

International Medical Device Regulators Forum
http://www.imdrf.org

 

NEW EUROPEAN MEDICAL DEVICE AND IVD REGULATIONS PUBLISHED ON 5 MAY 2017 
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

    FILE

2017/745

Europe Medical Device Regulation (MDR)


2017/746

Europe In Vitro Diagnostic Regulation (IVDR)

 

DIRECTIVES - Main legislation
(Compiled from the accessible information at the Web:http://ec.europa.eu/growth/sectors/medical-devices/guidance_en)

    FILE

MDD 93/42/EEC
 
concerning medical devices
 
List of harmonised standards under the Directive

 


IVDD 98/79/EC

Directive of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
 
List of harmonised standards under the Directive

 

DIRECTIVES – Classification
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Directive 2005/50/EC Reclassification of hip, knee and shoulder joint replacements

Directive 2003/12/EC Reclassification of breast implants

REGULATION - Electronic instructions for use of MD
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Regulation (EU) No 207/2012


Prováděcí nařízení Komise (EU) č. 920/2013 o jmenování oznámených subjektů

Commission Regulation (EU) No 920/2013 on the designation and the supervision of notified bodies




Doporučení Komise 2013/473/EU o auditech a posouzeních prováděných oznámenými subjekty v oblasti zdravotnických prostředků

Commission Recommendation 2013/473/EU on the audits and assessments performed by notified bodies in the field of medical devices



DIRECTIVES - MD manufactured utilising tissues of animal origin
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Regulation (EU) No 722/2012

DIRECTIVES - Variant Creutzfeld-Jakob Disease assai
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Directive 2011/100/EU

DECISIONS - Common Technical Specification on IVD
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Decision 2011/869/EU

Commission Decision 2002/364/EC

Commission Decision 2009/886/EC

Corrigendum to Commission Decision 2009/886/EC

DECISION - Eudamed - European Databank on Medical Devices
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)

  FILE

Commission Decision 2010/227/EU

MEDDEV - Guidelines relating to medical device Directives
(Compiled from the accessible information at the Web: http://ec.europa.eu/health

    FILE Version
2.1 - Scope, field of application, definition    

MEDDEV 2.1/1
Definitions of "medical devices", "accessory" and "manufacturer" April 1994

MEDDEV 2.1/2 rev.2
Field of application of directive "active implantable medical devices" April 1994

MEDDEV 2.1/2.1
Field of application of directive "active implantable medical devices February 1998

MEDDEV 2.1/3 rev.3
Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative December 2009

MEDDEV 2.1/4
Interface with other directives - Medical devices/directive89/336/EEC relating to electromagnetic compatibility and directive 89/686/EEC relating to personal protective  equipment March 1994
 
For the relation between the MDD and directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009
August 2009

MEDDEV 2.1/5
Medical devices with a measuring function June 1998

MEDDEV 2.1/6
Qualification and Classification of stand alone software July 2016

2.2 - Essential requirements
   

MEDDEV 2.2/1 rev.1
EMC requirements February 1998

MEDDEV 2.2/3 rev.3
"Use by" - date June 1998

MEDDEV 2.2/4
Conformity assessment of In Vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) products January 2012

2.4 - Classification of MD
   

MEDDEV 2.4/1 rev.9
Classification of medical devices June 2010

2.5 – Conformity assessment procedure - General rules
   

MEDDEV 2.5/3 rev.2
Subcontracting quality systems related June 1998

MEDDEV 2.5/5 rev.3
Translation procedure February 1998

MEDDEV 2.5/6 rev.1
Homogenous batches (verification of manufacturers' products) February 1998

2.5 – Conformity assessment procedure - Conformity assessment for particular groups of products
   

MEDDEV 2.5/7 rev.1
Conformity assessment of breast implants July 1998
 
Evaluation of medical devices incorporating products of animal origin.
(See MEDDEV 2.11/1 rev.2)
   

MEDDEV 2.5/9 rev.1
Evaluation of medical devices incorporating products containing natural rubber latex February 2004

MEDDEV 2.5/10
Guideline for Authorised Representatives January 2012

2.7 - Clinical investigation, clinical evaluation



MEDDEV 2.7/1 rev.4
Clinical evaluation: Guide for manufacturers and notified bodies June 2016

Appendix 1: Clinical evaluation on coronary stents December 2008

MEDDEV 2.7/2 rev.2
Guide for Competent Authorities in making an assessment of clinical investigation; notification September 2015

MEDDEV 2.7/3 rev3
Clinical investigations: serious adverse event reporting May 2015

MEDDEV 2.7/4
Guidelines on Clinical investigations: a guide for manufacturers and notified bodies December 2010

2.10 - Notified bodies



MEDDEV 2.10/2 rev.1
Designation and monitoring of Notified Bodies within the framework of EC Directives on Medical devices April 2001


Annex 1



Annex 2



Annex 3



Annex 4


2.11 - Products using materials of biological origin




MEDDEV 2.11/1 rev.2

Application of Council Directive 93/42/EEC taking into account the Commission Directive 2003/32/EC for Medical Devices utilising tissues or derivatives originating from animals for which a TSE risk is suspected January 2008

Annex 1

2.12 - Market surveillance



MEDDEV 2.12/1 rev.8
Medical Devices Vigilance System    January 2013


Manufacturer Incident Report



How to use the MIR



Field Safety Corrective Action



Trend Report



Periodic Summary Report




MIR and FSCA xml files




List of contact points



MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies January 2012

2.13 - Transitional period



MEDDEV 2.13 rev.1
Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (OJ 98/C 242/05) August 1998


As regards the transitional regime of Directive 2007/47/EC see the Interpretative Document of the Commission's services of 5 June 2009
June 2009

2.14 - IVD



MEDDEV 2.14/1 rev.2
Borderline and Classification issues. A guide for manufacturers and notified bodies January 2012

MEDDEV 2.14/2 rev.1
Research Use Only products February 2004

MEDDEV 2.14/3 rev.1
Supply of Instructions For Use (IFU) and other information for In-vitro Diagnostic (IVD)Medical Devices January 2007


Form for the registration of manufacturers and devices In Vitro Diagnostic Medical Device Directive, Article 10
January 2007

MEDDEV 2.14/4
CE marking of blood based in vitro diagnostic medical devices for vCJD based on detection of abnormal PrP January 2012

2.15 - Other guidances



MEDDEV 2.15 rev.3
Committees/Working Groups contributing to the implementation of the Medical Device Directives December 2008

NBOG - Documents provide guidance on specific aspects related to the activities of NB
(Compiled from the accessible information at the Web: http://www.nbog.eu)



FILE Version
NBOG BPG 2016-1 (Re-)designation of notified bodies: Process for joint assessments Jun 2016

NBOG BPG 2014-1
Renewal of EC Design-Examination and Type-Examination Certificates: Conformity assessment procedures and general Nov 2014

NBOG BPG 2014-2
Guidance on the Information Required for Notified Body Medical Device Personnel Involved in Conformity Assess-ment Activities Nov 2014

NBOG BPG 2014-3
Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System Nov 2014

NBOG BPG 2006-1
Change of Notified Body Nov 2008

NBOG BPG 2009-1
Guidance on Design-Dossier Examination and Report Content Mar 2009

NBOG BPG 2009-2
Role of Notified Bodies in the Medical Device Vigilance System Mar 2009

NBOG BPG 2009-3
Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment Mar 2009

NBOG BPG 2009-4
Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis Jul 2009

NBOG BPG 2010-1
Guidance for Notified Bodies auditing suppliers to medical device manufacturers Mar 2010

NBOG BPG 2010-2
Guidance on Audit Report Content Mar 2010

NBOG BPG 2010-3
Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC Mar 2010

NBOG Checklists



NBOG CL 2010-1
Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation Mar 2010

NBOG Forms



NBOG F 2014-1
Application form to be submitted when applying for designation as a notified body Nov 2014

NBOG F 2014-2
Qualification of personnel (see NBOG BPG 2014-2) Jun 2016

NBOG F 2012-1
Notification form – Directive 93/42/EEC Jan 2013

NBOG F 2012-3
Notification form – Directive 98/79/EC Jan 2013

NBOG F 2010-1
Certificate Notification to the Commission and other Member States Mar 2010




VIGILANCE
(Compiled from the accessible information at the Web: http://eur- lex.europa.eu)



FILE Version

MEDDEV 2.12/1 rev.8
Medical Devices Vigilance System January 2013


Manufacturer Incident Report



How to use the MIR



Field Safety Corrective Action



Trend Report



Periodic Summary Report



MIR and FSCA xml files




List of contact points



MEDDEV 2.12/2 rev.2
Post Market Clinical Follow-up studies January 2012

GHTF Study Group 5 Documents  - Clinical Safety/Performance
(Compiled from the accessible information at the Web: http://www.imdrf.org/documents/doc-ghtf-sg5.asp)



FILE Version
GHTF-SG5-N2R8:2007
Clinical Evaluation
May 2007
GHTF-SG5-N3:2010
Clinical Investigations
February 2010
GHTF-SG5-N4:2010
Post-Market Clinical Follow-Up S
tudies
February 2010

 

Aktualizováno: 18. května 2017
 
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