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:
- 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
EC 05-Sept-2007.pdf (~ 190 KB)
- 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)
A German pilot project has clearly shown that the HIBC system is the best
in fulfilling the legal
- 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:
(~ 505 KB)
(~ 694 KB)
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
(~ 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
(~ 280 KB)
For technical support Europe wide, please contact
or the HIBC secretariat www.ehibcc.com
or the FIDE secretariat
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
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
- REACH-Regulation 18 Dec 2006
(~ 1,8 MB)
- REACH-Summary May 2007
(~ 3,6 MB)
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.
- 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.
(~ 288 KB)
- The following document gives contact information
for national registry offices.
WEEE_Registry_Offices_in_the_EU_Jan_06.doc (~ 92
- FIDE-Information on the transposition of WEEE
in the EU-Member-States.
(~ 72 KB)
- Joint Statement of
the medical device industry on the RoHS-Directive (2002/95/EG).
(~ 358 KB)