European Medical Device Regulation has been saved
European Medical Device Regulation
The complexity of qualification and classification
The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safe and effective performance of medical devices before and after these are brought to the EU market. There is no one-size-fits-all-solution for the implementation of the medical device regulations.
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- EU-MDR demands
- How to qualify and classify a medical device?
- Four classes in EU-MDR
- Classification in EU-MDR
Medical devices, other than In Vitro Diagnostics, are governed under the EU-MDR. Only CE-marked medical devices can be sold on the EU market. By affixing the CE-mark the manufacturer declares that the applicable legal requirements are met and that the medical device is safe for use and performs as intended.
The EU-MDR came into effect as of 26 May 2021 and has replaced the Medical Device Directive 93/42/EC (MDD) and the Active Implantable Medical Device Directive 90/385/EC (AIMDD).
Compared to the directives, the EU-MDR demands:
- greater transparency
- enhanced harmonisation and standardisation
- more regularity scrutiny
- more stringent criteria for clinical evidence and clinical evaluation
- increase in obligations and oversight of economic operators and notified bodies
- heightened traceability across supply chain through Unique Device Identification (UDI)
In addition, stricter requirements are being introduced that affect many functions and activities, especially those related to:
- Cyber security and Privacy
- Quality Management System (QMS)
- EUDAMED and Unique Device Identification (UDI)
- Clinical Evidence and Clinical Evaluation
- Technical documentation
- Economic operators and the Person Responsible for Regulatory Compliance (PRRC)
- Software as a medical device (SaMD)
- Post market surveillance (PMS) & Vigilance
- Device classification and Conformity Assessment
How to qualify and classify a medical device?
According to the EU-MDR, a medical device typically means any product which is intended to be used for humans for a specific medical purpose and which achieves its principal intended action by physical means. Products for the control of conception and products for cleaning, disinfection or sterilisation of medical devices are also considered medical devices.
Medical devices come with many different forms and functions. Nevertheless, all medical devices placed on the EU market shall meet the General Safety and Performance Requirements set out in the EU-MDR that apply for that device. Applicable (Harmonised) Standards and Common Specification should be used as much as possible in order to demonstrate conformity of the device with these Requirements.
Four classes in EU-MDR
Medical devices are classified into 4 classes by taking into account the intended purpose of the device and its inherent risks associated with the technical design and manufacturing processes.
- Class I – low risk
- Class IIa – low-medium risk
- Class IIb – medium-high risk
- Class III – high risk
Classification in EU-MDR
To rightly classify a medical device, a series of classification rules shall be followed that are based on the vulnerability of the human body and consider the duration of use, invasiveness, potential toxicity and the body part(s) affected. The higher the risk class of the device, the more regulatory scrutiny and stricter regulatory requirements apply for conformity assessment of that device. Wrongly classifying your device could negatively impact your regulatory strategy planning in terms of the estimated time, effort and budget for market introduction. This often leads to increased spend and time-to-market delays.
Conformity assessment for class I devices should be carried out under the sole responsibility of the manufacturer in view of the low risks associated with the device. This means that the manufacturers of class I devices (except for Class Is, Im and Ir*) shall self-declare conformity of their devices and apply the CE mark. For class IIa, IIb and III medical devices involvement of a Notified Body is always required.
The process of obtaining CE marking for medical devices can be long and complex. There is no one-size-fits-all-solution for the implementation of the medical device regulations. Endless variations exist between device types, manufacturers and supply chain process interactions. In addition, the MDR has introduced a higher conformity assessment scrutiny.
We provide a wide range of strategic and hands-on quality and regulatory support services in Device Lifecycle Support, Quality and Regulatory Automation and Training.
* For Class I devices that are placed on the market in sterile condition (class Is), have a measuring function (class Im), or are reusable surgical instruments (Class Ir) Notified Body involvement is required for the aspects that relate to respectively the sterility, metrological requirements, or the reuse of the device.
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