Affixing the CE marking is legally required in order to place medical devices on the EU market. By affixing the CE marking, the manufacturer declares that the medical device complies with all relevant safety and performance requirements. In order to provide a product with a CE marking within the scope of of the MDD/MDR, it must be classified as a medical device, classified according to a risk class.
The MDR applies to medical devices, accessories of medical devices and medical software.
Medical devices are broadly defined within the MDR as any instrument, apparatus or appliance, software, implant, reagent, material or other item intended by the manufacturer to be used for humans for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of illness, injuries or disabilities.
Accessories of medical devices refer to articles that despite not being medical devices in their own right, are specifically intended by the manufacturer to be used with a medical device.
We refer to software as medical device software (‘MDSW’) when it meets the definition of software (i.e. a set of instructions that processes input data and creates export data) and at the same time is intended for a medical application as stated in the definition of medical devices. Medical software can be used independently (SaMD: Software as a Medical Device) or drives and/or influences the use of a medical device.
The MDR does not apply to:
Certification Company is an independent all-round regulatory specialist in the field of CE marking of medical devices. We provide consultancy services to manufacturers, importers, distributors and healthcare institutions in regard to the accurate and complete implementation of the Medical Devices Regulation ('MDR'). Our pragmatic solutions and services are primarily (but certainly not exclusively!) focused on medical devices falling within risk class I and medical software/applications. Provided that entire CE conformity assessment procedures are assigned to Certification Company, we offer you our expertise on an ad hoc basis, subject to the the following conditions:
1. MDR base: telephone and email guidance by a specialist;
2. MDR-intensive: consultancy services provided by a specialist through direct communication (telephone and video teleconferencing);
3. MDR-on-site: on-site consultancy services.
Present substantiated qualification and justify classification of a medical device.
The risk management system will be designed and implemented in accordance with EN-ISO 14971.
The quality management system is designed and implemented in accordance with EN-ISO 13485.
Including, among others, the general safety and performance requirements, the clinical evaluation, post-market surveillance procedure, instructions, labels and marking.
Registration of accessories (UDI) and market participants. Designate Notified Body responsible for compliance
Draw up the EU Declaration of Conformity and provide instructions for affixing the CE Marking in accordance with the requirements of the Medical Devices Regulation.
Are you a manufacturer, authorised representative or importer of a medical device? If so, you will soon (most likely in May 2022) need to register information about yourself, your company and the medical device in EUDAMED.
Implementing Regulation (EU) 2021/2226 makes possible for manufacturers of medical devices to provide electronic instructions for use only. Read more about the conditions of EU 2021/2226.
On January 4, the European Commission recognised nine harmonised standards for medical devices that manufacturers can reference in order to satisfy conformity requirements under the Medical Devices Regulation (MDR 2017/745).