REGULATORY AFFAIRS

1. Regulatory Policies Europe
2. Regulatory Affairs World Wide
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)

- The Notified Bodies have established several Notified Bodies Recommendations. Some of
  them are adopted as MEDDEV documents. All documents are very helpful in the cooperation
  between manufacturer and its Notified Body.

     Notified_Bodies_Recommendations.zip (~ 1,5 MB)

    Consensus_statements_of_Notified_Bodies.doc (~ 411 KB)



2. Regulatory Affairs World Wide

- In addition, the FDA has established a new web-site for 510(k) information:

   http://www.fda.gov/cdrh/devadvice/314a.html


- The Global Harmonisation Task Force, GHTF prepares proposals for the national governments
  for the harmonisation of regulatory requirements. All information is on the website:

   http://www.ghtf.org

- A recent report on the development of the GHTF activities and documents is enclosed. It
  contains some questions which the FIDE head quarter is requesting urgently:

    GHTF recent devel.doc (~ 377 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)

- In cooperation with the GHTF Study Group 4 "Auditing" the German association VDDI
  organised a seminar on 25 September 2003 in Frankfurt under the topic
  "Market access in the USA". The contributions are enclosed:

    Chris_Nelson_-_FDA_Approach_to_Auditing.ppt (~ 182 KB)

    Robert_Turocy_-_Preparation_for_FDA.ppt (~ 224 KB)

- The European federations have developed a guidance, how products have to be labelled in
  the view of manufacturer, importer, dealer and legal representetive:

     Own_brand_labelling.zip (~ 362 KB)

    Own_brand_labelling.doc
(~ 2,8 MB)



4. Standardization


  The plenary of CEN TC 55 "Dentistry" met on 15 February 2005 in Brussels. A short report for
  FIDE by Linda Sanin as well as the report of the secretariat are enclosed.

     Report_on_CENTC55_15.2.2005.pdf (~ 84 KB)

     Attachments_CENrep.pdf
(~ 877 KB)


  Within a Joint-Working-Group of IEC and ISO a new project was established on the issue
  "Usability" for all medical devices. There is a close connection to ISO 14971 "Risk
  Management" and ISO 13485 "Quality Management".

  A recent meeting report:

    IEC/ISO JWG 4 usability.doc (~ 51 KB)


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)

 - Unique Identification Mark (UIM) especially for small items and instruments as addendum to
   the HIBC standard

    UIM_english_Dec_2002.pdf (~ 482 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


FIDE was asked by the EU-Commission to collect information about the state of the art of amalgam and alternative fillings and evaluate the cost-benefits implications for patients. The results of the FIDE survey are: Amalgam is more durable, easier to use and much cheaper than alternatives.

     Position_FIDE_on_amalgam2007.doc (~ 99 KB)



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)


FIDE – The Federation of the European Dental Industry – Aachener Straße 1053-1055 – D-50858 Köln or: P.O.Box 40 06 63 – D-50836 Köln
phone: ++49/221-50 06 87-23 – fax:++49/221-50 06 87-21 – info@fide-online.org