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Kiwa Dare designated under the MDR
Kiwa Dare first Notified Body in the Netherlands! -
As of the 5th of November 2019, the Nando database listsKiwa Dare B.V. as Notified Body under the new European Medical Device Regulation (MDR). Kiwa Dare became the sixth Notified Body in Europe and the first designated Notified Body of the Netherlands under the MDR!
Link naar Nando Database
Scope expansion
Kiwa Dare also broadened the scope. For example with devices for hyperthermia and for ear, nose, throat surgery. In addition, Kiwa Dare is now allowed to assess the sterility validation of Class I equipment. This is of importance, since a lot of accessories of medical devices are required to be sterile. With the current scope of active (electrical) medical devices, including standalone software, Kiwa Dare has laid a strong foundation for the future!
Special position
Compared to other Notified Bodies, Kiwa Dare still is a relatively small organization. Many considered it hard or even impossible for a "newcomer" to be designated under the MDD, let alone the MDR. Although it was a long and complex endeavor, the contrary has been proven! Since 2014, over 30 Notified Bodies have lost their designation and only a few, including Kiwa Dare, have joined the remaining group of MDD/MDR Notified Bodies. This illustrates the uniqueness of the achievement. Until now, not all Notified Bodies applied for the MDR and some large organisations indicated even opted out for the designation. To fill in the emerging need for Notified Body capacity, DMC wants to expand its organization and is therefore actively searching for new lead auditors.
From MDD to MDR
Around the end of 2018, DMC was designated for the Medical Devices Directive (MDD). This designation covered Annex II till Annex V. DMC is now designated for the same schemes within the MDR (regulation (EU) 2017/745). However, the numbering has changed as shown in the table below.
Schedule Annex MDD – Annex MDR
| Volledig kwaliteitsborgingssysteem | II | IX |
| EG-typeonderzoek | III | X |
| EG-keuring / productverificatie | IV | XI deel B |
| Productiekwaliteitsborging | V | XI deel A |
Part of the transition from the MDD to the MDR is that each medical device needs to be recertified in accordance to the MDR. This will put a tremendous pressure on the remaining Notified Bodies. Especially, since the expected audit time under the new regulation will increase considerably. In addition, the imminent Brexit and the fact that Turkish Notified Bodies cannot be designated under the MDR, will add to the need for capacity. The expectation is that only a small part of the medical devices will be certified under the MDR in time (by the 20th of May 2020). Only devices that have a valid Notified Body certificate in conformity with the MDD by May 2020, may still be placed on the market under strict conditions and up to a maximum of four years.
CE Marking and safe Medical Devices
The approval of a Notified Body is needed to legally apply CE Marking on medical devices above risk class I. Nearly everyone will sooner or later get in touch with simple or advanced medical devices. Whether it is at the dentist, ophthalmologist, general practitioner or even during a stay in the hospital, medical devices are used everywhere. At this time a lot of new innovative medical devices are developed in the Netherlands and elsewhere in the world. This is certainly the case for Small and Medium sized Enterprises (SME) and startups in and around university medical centers. A competent partner who reviews and approves the quality management systems and technical product files for these organizations is of great importance. A Notified Body plays an important role within the CE Marking of medical devices and makes a major contribution to the safety of these kind of devices. This way DMC enables its customers to achieve a good competitive position on the international market for medical devices.
Importance of a Notified Body
Medical devices are important but can be dangerous to both patients and medical practitioners. For this reason, there are very strict requirements enforced on manufacturers and their certification bodies.
The certification of medical devices goes way beyond assessing the safety of a device alone. Manufacturers must also prove that the clinical performance can be met for the claimed indications and intended patient category. And that the benefits of the treatment outweigh the risks. The assessment includes for this reason aspects like risk management, usability, clinical evaluation and biocompatibility.
Kiwa Dare B.V.
Kiwa Dare B.V. conducts under accreditation a broad range of calibrations, tests, measurements and certifications in compliance with ISO 17021 and ISO 17025. Kiwa Dare is accredited for, System certifications (C637), Calibrations (K063) and Testing (L279) by the Dutch Accreditation Council (RvA).
Future
The designation is the third and final step in a process that started ten years ago. Kiwa Dare aims, with this important designation, to put the focus on Dutch SME’s and startups that are active in the creation and innovation of medical devices.