Iperion – a Deloitte business assists manufacturers of medical devices with a wide range of quality and regulatory support services throughout the entire device life cycle
EU-MDR and CE-marking requires dedicated and specialized regulatory knowledge and practical experience
We have the right expertise for defining optimal strategies for placing and maintaining medical devices on the EU market
We are specialized in Quality and Regulatory Compliance for Medical Devices in particular Regulation (EU) 2017/745 (EU-MDR). We assist manufacturers and other economic operators through compliance readiness and maturity assessments and by delivering compliance remediation and transformation projects.
We provide a wide range of strategic and hands-on quality and regulatory support services in three main areas:
- Device lifecycle support : from regulatory strategy development to product realization, market authorization & registration and post-market surveillance.
- Quality and Regulatory Automation : to automate regulatory intelligence, improve quality and regulatory information management and to speed regulatory submissions.
- Training : to establish appropriate understanding of EU-MDR, the impact and benefits for all levels within your organization, and to leverage best practice solutions seen in the industry.
Our focus areas
The process of obtaining the CE marking can be long and complex. There is no one-size-fits-all-solution for the implementation of the regulations. Endless variations exist between device types, manufacturers and supply chain process interactions.
Dedicated regulatory knowledge and practical experience are essential to overcome the regulatory hurdles faced by manufacturers and to design and implement the best possible solution for a device and the applicable lifecycle processes.
Iperion assists the medical device industry with delivering regulatory compliance and transformation projects covering a wide range of medical device types such as:
- Digital / Connected Medical Devices
- Combination Medical Devices (including Drug-Device Combinations – DDCs)
- Implantable Medical Devices
- Substance-based Medical Devices
What is MDR?
The European Medical Device Regulation 2017/745 (EU-MDR) provides a regulatory framework with the purpose of ensuring safety and effective performance of medical devices before and after these are brought to the EU market.
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 harmonization and standardization
- more regularity scrutiny
- increase in oversight of economic operators
- heightened traceability through 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
- 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 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 sterilization 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 (Harmonized) Standards and Common Specification should be used as much as possible in order to demonstrate conformity of the device with these Requirements.
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
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 manufactures 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.
OUR LOCAL REPRESENTATION IN MANY COUNTRIES AROUND THE WORLD ALLOW US TO EASILY NAVIGATE ACROSS THE DIFFERENT MARKET AUTHORIZATION AND REGISTRATION LANDSCAPES.
OUR GLOBAL REGULATORY NETWORK ENABLES US TO CONSIDER THE REGULATORY REQUIREMENTS AND STANDARDS FROM A BROADER INTERNATIONAL PERSPECTIVE.
WE HAVE CLOSE CONTACTS WITH THE REGULATORY BODIES WHICH PROVIDE US WITH A GOOD UNDERSTANDING OF CONFORMITY ASSESSMENT / CONSULTATION PROCESSES.
WE SERVE MEDICAL DEVICE COMPANIES WORLDWIDE WHICH GIVES US GOOD INSIGHT INTO LEADING PRACTICES USED IN THE INDUSTRY.
Since we joined Deloitte we have access to new expertise and experience, including on Medical Devices. We are pleased to be offering these services to our current and new clients. Please contact us if you can use our support.
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