“Certification according to the Medical Devices Directive ...

For a safe and interference-free world

Medical Certifications

Notified Body of Active Medical Devices

¡°Certification according to the Medical Devices Directive (MDD) 93/42 / EEC¡±

Modular ? Flexible ? Multi-band ? Easy to use ? Open ? Traceable Results ? Standardized

DARE!! Medical Certifications is a Notified Body (NB 1912) for the Medical Devices Directive 93/42/EEC. We have a specific scope

with regard to active non-implantable medical devices. European and International Authorities have set forward a large number

of requirements for medical devices. For many start-ups and small and medium sized businesses these requirements may

represent a barrier to the European Economic Area (EEA) of medical devices. Especially for these kind of organisations, DARE!!

Medical Certifications provides, next to Annex II / V for quality management systems, the very interesting alternative route for

small numbers of products, according to Annex III / IV.

Importance of medical devices

including the proper classification, the applicable standards and

Advanced medical devices play an ever-increasing role in the

the required documentation as well as the required time and

health care arena. Many new and innovative medical devices are

competence to perform the certification process. The Application

developed by spin-offs of academic research. A reliable partner

Review ensures that the total project can be performed in a

that can certify medical devices is of the utmost importance.

fluent way and prevents surprises that will lead to a delay of the

Both to ensure a strong competitive position on the international

formal audit or assessment and thus to the time to market.

market and maintaining a high level of quality of medical devices.

Notified Body

CE Marking

The Dutch department of health (VWS) has designated DARE!!

DARE!! Medical Certifications performs conformity assessments

Medical Certifications as a Notified Body for the European

under the medical devices directive and acts as a Notified Body

Medical Devices Directive 93/42/EEC for the annexes II, III, IV and

for the classes I-measure, IIa and IIb. For these classes a Notified

V non-sterile non-implantable active (electronic) equipment for a

Body is a requirement to obtain CE marking. The CE marking is

wide scope of medical devices. See the rear of this leaflet for our

mandatory to allow medical devices to be put on the market in

complete scope.

the European Economic Area (EEA). Our experienced technical,

clinical and certification employees have the required knowledge

Quality

and experience with regard to the latest developments in this field

It is the responsible task of DARE!! Medical Certifications experts,

and can, therefore, counsel you on the applicable harmonized

product reviewers and (lead)auditors to perform the proper

standards and regulations. Audits, assessments and tests are

assessments. Not only with the goal to obtain the required CE

performed with a high degree of quality and in accordance with

marking but also to protect manufacturers against substantial

the standards and regulations.

claims or even prosecution. At the same time, a device in

compliance with the Medical Devices Directive must be a reliable

Conformity Assessment Procedure

device, thus resulting in savings in the

Before the formal assessment takes place, an Application Review

after sales cost. A reliable product also protects your reputation

is performed. During this assessment, the total project is reviewed

as a high-quality manufacturer!

Dijkstra Advice, Research & EMC Services B.V.

Vijzelmolenlaan 7

T: +31 348 430 979

3447 GX Woerden

M: mddcert@dare.nl

The Netherlands

W: medical.dare.nl

The Standard for product

certification in EMC, Product

Safety & Medical Devices

Copyright? 2017 All rights reserved by DARE!! Medical Certifications

Medical Certifications

Product / Product Group

Certification Scheme

Standard / Normative

document

General active medical devices

MD 1101 Devices for extra-corporal circulation, infusion and

haemopheresis ¨C limited to devices for administration

and removal of substances

MD 1102

Respiratory devices, devices including hyperbaric

chambers for oxygen therapy, inhalation anaesthesia

¨C excluding inhalation anaesthesia devices, lung

ventilators and heart-lung machines

MD 1103

Devices for stimulation or inhibition

MD 1104

Active surgical devices

MD 1105

Active ophthalmologic devices

MD 1106

Active dental device

MD 1108

Active rehabilitation devices and active prostheses

MD 1109

Active devices for patient positioning and transport

MD 1111

Stand alone software - limited to the procedures as

Medical Certifications ¨C October 2018 ¨C version 2 | Specifications are subject to change without notice.

described in Annex II

Devices for imaging

MD 1202

Imaging devices utilising non-ionizing radiation

Monitoring devices

MD 1301

Monitoring devices of non-vital physiological

European Directive 93/42/EC

European Directive 93/42/EC

(Medical Devices)

EN-ISO 13485:2016

Annex II

(Full quality assurance system)

Annex III

(EC Type Examination)

Annex IV

(EC Verification of

products and batches)

Annex V

(Production quality assurance)

parameters

MD 1302

Monitoring devices of vital physiological parameters

Devices for radiation therapy and thermo therapy

MD 1402

Devices utilising non-ionizing radiation

MD 1403

Devices for hyperthermia / hypothermia

Specifics of Medical Devices

MDS 7004

Medical devices referencing the Directive 2006/42/EC

on machinery

MDS 7010

Medical devices incorporating software / utilising

software / controlled by software

For more information contact

DARE!! Medical Certifications at:

T: +31 348 430 979

M: mddcert@dare.nl

W: medical.dare.nl

Dijkstra Advice, Research & EMC Services B.V.

Vijzelmolenlaan 7

T: +31 348 430 979

3447 GX Woerden

M: mddcert@dare.nl

The Netherlands

W: medical.dare.nl

Copyright? 2018 All rights reserved by DARE!! Medical Certifications

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