1. Regulatory Policies Europe
2. FIDE Position Papers
3. Industrial Documents
4. Standardization
5. Bar Code
6. REACH
7. Dental Amalgam
8. WEEE


1. Regulatory Policies Europe


- On 5 April 2017, the new "Regulation on Medical Devices (EU 2017/745) " was adopted.
  This regulation will replace the existing Medical Device Directive after a transition
  period of three years. The new rules will only apply from 27 May 2020.

  The text can be find under:
  https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_de

- The Medical Device Directive came into force in 1993. This directive covers the placing in the
  market and putting into service of medical products.

  The revision of this directive started in 2005 and was adopted in 2007. The amendment
  directive 2007/47/EC of the European Parliament and of the Council was published on 5
  September 2007. For more information please contact the official homepage of the European
  Commission.

  http://ec.europa.eu/enterprise/medical_devices/index_en.htm

  MDD_Directive_1993-42EEC.mht

     MDD_Amending_Directive_2007-47 EC 05-Sept-2007.pdf (~ 190 KB)




2. FIDE Position Papers

- The new classification rule 19 in the European Regulation on Medical Devices EU 2017/745
  deals with the classification of medical devices containing nanomaterials. Key aspect of this
  classification is the "potential for internal exposure", which may be "high, medium, low or
  negligible". FIDE member companies (working group nanotechnology) came to the result that
  from dental materials no significant exposure to nanoparticles can be expected. Details are
  available in the FIDE position paper on "nanomaterials in dental materials".

    Nanomaterials in Dental Materials_FIDE-EN-2018-01-30.pdf (~ 232 KB)

- An increasing number of dental manufacturers are becoming involved with 3D printing
  technologies. A working group developed the position paper on dealing with custom-made
  devices according to the European Regulation on Medical Devices. Bitte darunter den

    3D-Printing-Position-Paper_FIDE-EN-2018-02-23-final.pdf (~ 2092 KB)



3. Industrial Documents

- CE Mark
  The German and European medical devices associations have developed a flyer which
  explains the high value of the CE mark.

    EURO_CE-Flyer_2008.pdf (~ 128 KB)

    CE-Flyer_deutsch 2008.pdf (~ 123 KB)

- Together with the representatives of the member states, FIDE has established an overview
  of the existing language requirements in the national medical devices legislation.
  The directive leaves the language requirement to the national legislation. How it is ruled:

     Mandatory_Language_Requirements_for_Medical_Devices.zip (~ 505 KB)

    Mandatory_Language_Requirements_for_Medical_Devices.doc (~ 694 KB)



4. Standardization





5. Bar Code


 Which Bar Code system is most suitable for the dental branch?

 A German pilot project has clearly shown that the HIBC system is the best in fulfilling the legal
 requirements related to label information and traceability.

 The enclosed brochures give all necessary information for implementing the bar code Health
 Industry Bar Code, HIBC:

 - HIBC Guide

     HIBC_Guide_english_Nov_2002.pdf (~ 506 KB)

 - AIDC supported clinical process, hygiene process for instruments

    AIDC supported clinical process-131115-E.pdf (~ 287 KB)

- Bar Code Strategy - the working group Bar Code compiled the Bar Code Strategy 2005

     Barcodestrategy_2005-03-31.pdf (~ 280 KB)


 For technical support Europe wide, please contact

     Mr. Heinrich Oehlmann
   www.hibc.de Tel: +49-3445-87 11 40
   info@hibc.de Fax: +49-3445-77 01 42

 or the HIBC secretariat www.ehibcc.com

 or the FIDE secretariat



6 . REACH


REACH is a new EU-regulation and stands for "Registration, Evaluation and Authorization of Chemicals". This regulation was adopted on 18 December 2006 and comes into force on 01 June 2007. With REACH the EU is pursuing its primary aim of consolidating the fragmented chemicals law. The aim is to transfer existing different regulations relating to old and new substances into a harmonized system.

The new REACH regulation imposes requirements on manufacturers, importers and downstream users of pure chemicals and chemicals in preparations and manufactured goods. The aim is to ensure that no damage is caused to human health or the environment during the manufacture, placing on the market and use of substances under foreseeable conditions of use.

 - REACH-Regulation 18 Dec 2006

     REACH-Regulation_18_December_2006-engl.pdf (~ 1,8 MB)

 - REACH-Summary May 2007

     REACH_Summary_May2007.pdf (~ 3,6 MB)



7 . Dental Amalgam


The new EU Regulation on mercury is in force since 01 January 2018 and in all languages available under this link: http://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX:32017R0852 Key aspects are: From 01 July 2018 dental amalgam shall not be used for dental treatment of children under 15 years and of pregnant women. From 01 January 2019 only pre-dosed encapsulated dental amalgam should be allowed for use and the use of amalgam separators is mandatory. The EU Commission will assess on the feasibility of a phase out of the use of amalgam in a long term, preferably by 2030.




8. WEEE (Waste Electrical and Electronic Equipment)

- The WEEE (Waste Electrical and electronic equipment) which regulates the collection,
  withdrawal and recycling of obsolete electrical devices (sold later than 13.08.2005),has
  already gone into effect in as national law in several EU member states.

     EUGuideline_WEEE_13-02-2003_EN.pdf (~ 288 KB)

- The following document gives contact information for national registry offices.

    WEEE_Registry_Offices_in_the_EU_Jan_06.doc (~ 92 KB)

- FIDE-Information on the transposition of WEEE in the EU-Member-States.

    FIDE_WEEE_transposition_in_EU_member_states.doc (~ 72 KB)

- Joint Statement of the medical device industry on the RoHS-Directive (2002/95/EG).

    Position_document_of_the_Medical_Device_Industry_Release.doc (~ 358 KB)


 

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