|
S/01/95 |
Subcontracting of design and
production |
|
S/02/95 |
Demarcation with Medical Laboratory
Equipment |
|
S/03/95 |
European representative from
manufacturers from outside the Community |
|
S/04/95 |
Expiration date on packaging for
sterile products |
|
S/05/95 |
Packaging for instruments
sterilized by the user |
|
S/06/95 |
Product testing as part of the
surveillance of QS |
|
S/01/96 |
Validation of the technical
documentation as part of auditing under Annex V
and VI |
|
S/02/96 |
Classification of ear thermometers |
|
S/03/96 |
Authorized representative |
|
S/04/96 |
CE marking of refurbished devices |
|
S/05/96 |
CE marking of class I devices |
|
S/06/96 |
Declaration of reversed osmotic
systems |
|
S/07/96 |
Classification of devices for
disinfecting, cleaning, rinsing, hydrating |
|
S/08/96 |
Quality systems in case of complete
subcontracting |
|
S/09/96 |
Beautician equipment |
|
S/10/96 |
Road motor vehicle for handicapped
persons |
|
S/11/96 |
CE marking of separate sold devices |
|
S/12/96 |
Oven in dental laboratories |
|
S/13/96 |
Time limits of certificates |
|
S/14/96 |
Certification of subcontractor |
|
S/01/97 |
Nasal rinsing and humidifying
solutions; Classification |
|
S/02/97 |
Custom-made mouth guards;
Classification |
|
S/03/97 |
Laser equipment; Classification |
|
S/04/97 |
Gas distribution networks in
hospitals |
|
S/05/97 |
Borderline products between medical
devices and home training devices, or devices for
comfort, or cosmetic devices |
|
S/06/97 |
Classification of surgical
instruments |
|
S/07/97 |
Status of coatings of implants
|
|
S/08/97 |
Withdrawal or refusal of
certificates |
|
S/09/97 |
Classification of dialysis
concentrates |
|
S/10/97 |
Quality certificates for single
products |
|
S/11/97 |
OEM Products; certification |
|
S/12/97 |
Certification of class IIb products
in combination of Annexes II and V of the MDD |
|
S/13/97 |
Hearing aids |
|
S/14/97 |
Programmable electrical Medical
Systems |
|
S/15/97 |
Classification of a
medical-diagnostic device for determining woman’s
fertile and infertile period |
|
S/16/97 |
Resuscitation masks; categorisation |
|
S/17/97 |
Wigs and toupees; Classification |
|
S/18/97 |
Arms rests installed in buildings
for handicapped persons; Classification |
|
S/19/97 |
Brushers with disinfectants for use
by healthcare personnel; Classification |
|
S/20/97 |
Software programmes used for
patients to provide rehabilitation;
Classification |
|
S/21/97 |
Products made from latex |
|
S/22/97 |
Data Management and Exchange |
|
S/23/97 |
Storage solutions for organs;
classification |
|
S/24/97 |
Complex salt solution for
irrigation; classification |
|
S/25/97 |
Independence of the auditors |
|
S/26/97 |
Products in the distribution chain
and the impact of that in relation to the end of
the transition period |
|
S/27/97 |
Categorisation of devices for preparation of
solution bags¡ |
|
S/28/97 |
Declaration specifying that no
application has been lodged with any other
Notified Body for the same product/product related
quality system |
|
S/29/97 |
Categorisation of thermosealing
machine |
|
S/30/97 |
Are devices for storage of blood,
human cells and sperm which are determined to be
returned to the human body medical devices or not? |
|
S/31/97 |
Devices for use in heart surgery;
Classification |
|
S/32/97 |
Gloves; Classification |
|
S/33/97
|
Nebulizers (used to administer a
medicinal product, which was potentially hazardous
in reference to rule II, annex II) ;
Classification |
|
S/34/97 |
Products intended for rinsing;
Classification |
|
S/35/97 |
Storage solutions for organs;
Classification |
|
S/36/97 |
Complex salt solution for
irrigation; Classification |
|
S/37/97 |
Proteins - produced by genetic
means - which are used with devices for bone
repairing |
|
S/38/97 |
Dental filling material |
|
S/39/97 |
Products made from latex |
|
S/01/98 |
Demarcation Medical Devices,
Accessories and Production or Laboratory Devices |
|
S/02/98 |
Lasers for skin treatment (low
level laser therapy); classification |
|
S/03/98 |
Samples of certificates |
|
S/04/98 |
Blood bags with preservation
solution |
|
S/05/98 |
Decoupling of certificates |
|
S/06/98 |
Medical gas pipeline systems in
hospitals |
|
S/07/98 |
Retention periods for documents and
quality records |
|
S/08/98 |
Sterile patient drapes;
Classification |
|
S/09/98 |
Oximeter; Classification |
|
S/10/98 |
Auditing of internal audits
performed by a manufacturer within his QS |
|
S/11/98 |
Gases for driving medical tools |
|
S/12/98 |
Blood bags with preservation
solution |
|
S/13/98 |
Own brand labelling |
|
S/14/98 |
Refillable glass capsule containing
sodium-hydrogen carbonate (used to produce a
bicarbonate solution during dialysis) |
|
S/15/98 |
Surveillance - Inability to carry
out unannounced visits in Non-EU States |
|
S/16/98 |
Sterilisation of reusable medical
devices |
|
S/17/98 |
Low pressure regulators;
Classification |
|
S/18/98 |
Sterilizers used for final
sterilisation of medical devices to be put on the
market |
|
S/19/98 |
Re-use of single use devices |
|
S/01/99 |
Declaration of conformity |
|
S/02/99 |
Software; Classification |
|
S/03/99 |
Pools for training disabled persons |
|
S/04/99 |
Free movement, device intended for
special purpose |
|
S/05/99 |
Carotid shunt; Classification |