orangeglobal – Your specialist for registrations of medical devices and
in-vitro diagnostic devices
In order to be placed on the European market or to be put into service, medical devices must bear a CE mark. A CE mark, which is governed by European law, may only be applied if the device meets the basic safety and performance requirements specified in the relevant directives. It must previously have undergone a risk evaluation, a risk management procedure (risk minimisation) and a risk/benefit analysis, and a conformity evaluation procedure, commensurate with the risk of the device must have been successfully completed.
Evaluation procedures in the registration of medical devices
The conformity evaluation procedure to be performed and the extent to which an independent testing and certification body (notified body) should be involved depends on the potential risk of the devices. While active implantable medical devices are not distinguished further from a risk perspective, Directive 93/42/EEC provides for a differentiation into 4 classes (I, IIa, IIb, III). The classification is based on the criteria defined in Annex IX of Directive 93/42/EEC. In-vitro diagnostics are also divided into various groups for the purpose of allocation to the applicable conformity evaluation procedure (devices listed in Annex II List A of Directive 98/79/EC, devices listed in Annex II List B, devices for personal use, other in-vitro diagnostics). The evaluation of in-vitro diagnostics in accordance with Annex II of Directive 98/79/EC and in-vitro diagnostics for personal use requires the participation of a “notified body”.
orangeglobal supports companies and organisations in their plans to register medical devices and in-vitro diagnostics. We assist you with questions you have concerning the classification of your medical device right up to compilation of all the necessary documentation and accompany you throughout the entire conformity evaluation procedure right up to CE certification and the worldwide registration of your devices. We also support the lifecycle management duties of your medical device and IVD. orangeglobal helps you before, during and after the registration of your medical devices and IVD.
Registration of medical devices and IVDs
The orangeglobal service portfolio
1. Management of registration and approval for medical devices
- Regulatory development support and consulting
- Classification of your medical device, and support with demarcation queries concerning combination products
- Procurement of requirements in terms of registration and approval for new markets
- Development of customised marketing authorisation strategies around the world.
2. Regulatory documentation for medical devices
- Creation and revision of all regulatory documentation, risk management dossiers in accordance
with ISO 14971
- Clinical evaluation in accordance with MEDDEV 2.7/1 Revision 4
- Usability dossier in accordance with EN 62366 (including usability test), instructions for use, produced as printed or electronic media in accordance with Commission Regulation (EU) No. 207/2012 and labelling
- G-BA applications and list of assistive technology products approved by the German health insurance companies, process documentation (SOPs), regulatory and expert reports
- Technical translation of regulatory and vigilance documents
3. Regulatory submission procedures for medical devices
- Creation of technical documentation and summary technical documentation (STED)
- Verification of compliance with the “essential requirements” and regulatory requirements around the world
- Support, assistance and monitoring of EU conformity assessment procedures in accordance with MDD (93/42/EEC), AIMDD (90/385/EEC), IVDD (98/79/EC) as well as MDR 2017/745/EU and IVDR 2017/746/EU
- Communication with authorities and ‘notified bodies’
- Premarket notification 510(k) or PMA in the USA
- Other countries on request
4. Regulatory maintenance for medical devices
- Review and maintenance of your technical documentation, review of international regulatory requirements
- Revision of your current clinical evaluation in accordance with the current EU Directive MEDDEV 2.7/1 Revision 4
Orangeglobal’s added value to you in the registration of medical devices and IVDs
We also support you in implementing the new regulations for medical devices (MDR 2017/745/EU) and in-vitro diagnostics (IVDR 2017/746/EU), which replace the previous directives 93/42/EEC Medical Device Directive (MDD) and 90/385/EEC Active Implantable Medical Devices (AIMD)“ or 98/79/EC In-Vitro Diagnostic Directive. Every manufacturer of medical devices in class I to III (medical devices) or class A to D (in-vitro diagnostics) needs to come to terms rapidly with the new requirements.
The effects are far-reaching and concern medical devices of all classes. Now, for the first time, devices that are not medical devices will also be governed by the Medical Device Regulation (MDR). Changes include the classification of devices, previous “essential requirements”, technical documentation, clinical data, market surveillance and the quality management system. European registration is uniformly regulated and involves marked changes depending on corporate objectives. Far-reaching changes are engendered by the new scrutiny procedure, the requirements for reprocessing and the introduction of the European database, Eudamed.
Any questions about the registration of medical devices or in-vitro diagnostics?
Dr. Philip Welbergen MBA
Head of Global Regulatory Affairs & Vigilance
Tel. +49 (0) 731 954 95 - 513