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 Notified Bodies have established several Notified
Bodies Recommendations. Some of
A German pilot project has clearly shown that the HIBC system is the best
in fulfilling the legal
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
Consensus_statements_of_Notified_Bodies.doc (~ 411
- In addition, the FDA has established a new web-site
for 510(k) information:
- The Global Harmonisation Task Force, GHTF prepares
proposals for the national governments
for the harmonisation of regulatory requirements.
All information is on the website:
- 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)
- 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)
- 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
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:
(~ 362 KB)
(~ 2,8 MB)
The plenary of CEN TC 55 "Dentistry"
met on 15 February 2005 in Brussels. A short report
FIDE by Linda Sanin as well as the report of
the secretariat are enclosed.
(~ 84 KB)
(~ 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
A recent meeting report:
JWG 4 usability.doc (~ 51 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)
- Unique Identification Mark (UIM) especially
for small items and instruments as addendum to
the HIBC standard
(~ 482 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)
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
(~ 99 KB)
- 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)