CE Mark for Medical Devices
CE Mark for Medical Devices or the term CE Mark stands for Conformité Européenne, and this is a legal requirement to place the medical device on the market in Europe. CE Mark for medical devices shows conformity with the European Union Harmonization Legislation and EU Medical Device Regulation. In order to be CE marked device or CE labelled, firstly, medical devices should comply with the ‘general safety and performance requirements laid out in Annex I of MDR or IVDR. Secondly, medical devices must undergo conformity assessment procedures based on their classification and risk.
MDR 2017/745 Regulation and CE Mark for Medical Devices
On the 5th of April 2017, the EU adopted the new Medical Device Regulation, but the new regulation will enter into force after four year transition period ending on May 25, 2021. Below you will find the important changes, should follow and implement by all manufacturers.
- Change in device Classification
- Change in conformity assessment rules
- stronger supervision of Notified Bodies by national authorities
- The increased role of manufacturers, EU representatives, distributors& importers
- Implementation of UDI system
- registration with EUDAMED database
- General Safety and Performance Requirements (GSPR) replaces the Essential Requirements (ER)
- Additional evidence for clinical evaluations or own clinical data to provide sufficient clinical evidence.
- Technical File contents updated according to Annex II and III of the MDR
- must have an employee in every organization who is in charge of the company’s regulatory compliance.
- Increased liability of EU Authorised Representative along with the manufacturer.
- Article 10(4) of the MDR increased requirements for OBL manufactures. Annexes II and III make OBL have their own full-fledged technical file.
- Stricter control on high-risk devices with additional scrutiny mechanism with the involvement of a pool of experts.
- Introduction of patient implant card containing information about implanted medical devices.
- Additional requirements for Post-market surveillance and Periodic Safety Update Reports
MDR CE Certification Process
In order to commercialize medical devices in the EU market, the CE certificate for medical devices is a requirement in compliance with the EU medical device regulations, that is, MDR 2017/745. Following are the processes to attain a CE mark for medical devices:
- Appoint a person responsible for regulatory compliance.
- Determine classification of your device using Annex VIII of MDR (Class I self-certified, Class I sterile, measuring or re-usable, Class IIa, Class IIb Class III)
- Implement Quality Management System according to ISO 13485
- Prepare a Technical File based on the MDR, which includes the files of Risk Management, Clinical evaluation, Biological Evaluation, and so on
- Obtain a Unique Device Identifier (UDI) for your medical device
- Appoint a European Authorized Representative
- Submit the Technical File to the Notified Body and get the QMS audited by them
- Attain CE Certificate for Medical Device
- Prepare a Declaration of Conformity [DoC] with the applicable regulations and affix a CE Marking on your medical device
- Register the medical device and the UDI in the EUDAMED Database and add the UDI on the label of your medical device
- Place your Medical Device in the market and start the Post Market Surveillance activities.
- Notified Body will audit yearly to check the compliance of the device with MDR. Update your CER, PMS, and PMCF to maintain the CE Mark
Technical Documentation & MDR Compliance
More information about MDR Technical File
MDR Compliance & Role of Consultants
I3CGlobal will bring your medical devices to the European market in the most effective manner possible and will support you in overcoming any hurdle along the way, as they have in-depth insight and understanding of complex regulatory requirements.
I3CGlobal Medical Device CE Marking Consultants supports you in the following manner:
- Understand your medical devices/IVDs and the applicable regulations at the earliest due to their vast experience in this field;
- Easily finds out the conformity assessment route and applicable Harmonized standards;
- Consultants will guide and support in Technical documentation / Design Dossier;
- Experienced in QMS implementation;
- Assists in DoC preparation;
- Supports in CE certification Audits;
- Guides in Post Market Surveillance and Post Market Clinical Follow-up;
Creates procedures and templates as the regulatory requirements.
Furthermore, you might be a small-medium or large-scale medical device manufacturer. No matter we are there to support MDR compliance by drafting technical files in the right way. For more information write to us.
Does I3CGlobal support usability engineering?
Yes. We support Usability Engineering documentation
Is IEC 62304 Implementation mandatory for software CE Marking?
The latest Medical Device software validation method (life cycle process model) developed is IEC 62304:2015 or ISO 62304. The new standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management. As per clause 3.12 of IEC 62304:2015, a Medical Device Software means “SOFTWARE SYSTEM that has been developed for the purpose of being incorporated into the MEDICAL DEVICE being developed or that is intended for use as a MEDICAL DEVICE in its own right”.
Do the consultants assure CE Certificate?
By supporting on attaining the CE mark and QMS implementation, consultants play very crucial roles in assuring CE certificate from the Notified Bodies.
What are the factors affecting CE Certification Cost?
Cost of testing as per the harmonized standard
Notified Body Fees including auditor travel
Consultants fees towards guidance and preparation of Technical File/Design Dossier
Annual Surveillance Audit
ISO 13485 Implementation and Certification Fee
EU MDR Classification
In order to classify your product, the first step in EU regulatory process is determining which regulation is applicable to your product, that is, MDR 2017/745 or IVDR 2017/746. For the purpose of classification there are 22 rules in Annex VIII of the MDR
Classification are as follows:
Class I– Provided non-sterile or do not have a measuring function (low risk)
Class I– Provided sterile and/or have a measuring function (low/medium risk); the MDR adds reusable surgical instruments as Class I reusable surgical instruments, to this group.
Class IIa(medium risk)
Class IIb(medium/high risk)
Class III(high risk)
What is a Medical Device?
Any device that helps patients and medical professionals diagnose, treat, beat illness or disease, and enhance their quality of life while being safe and effective is considered a medical device. It can take the shape of a tool, machine, implant, in-vitro reagent, or other closely connected item with a component, accessory, etc. It must have logical assurance from a standard regulatory authority or recognition. Although it is believed to affect any bodily physiology or structure in either humans or animals, it has no pharmacological effects.
Define Software Device (SaMD)?
Software as a Medical Device, also known as Medical Apps, Web-based Apps, etc., is Standalone software that performs medical functions without the use of hardware. It is typically used in conjunction with computing systems that are not connected to medical networks. It has been completed to enable technology and connectivity to devices in addition to humans so that performance, efficacy, and safety may be continually monitored. It also prioritizes clinical examination and provides specific classification based on risk-based criteria. SaMD's primary focus is on ensuring clinical efficacy and patient safety without sacrificing rapid innovation.
Define Active Device?
An active device is a medical device that functions by converting external energy into electrical energy or other power for its intended use rather than being directly created by the human body or gravity.
Examples include radiation therapy, body-worn sensors, hearing aids, heart-lung machines, and ablation devices.
Define Non-Active Device?
Non-active medical devices are ones that may be used for their intended purposes without requiring an external source of power or energy. Simply said, they are thought of as passive objects free from active endeavors.
Examples include orthopedic implants, surgical tools, or other sterile, one-time use gadgets.
Define Implantable Device?
An implantable device is a medical device that is partially or entirely inserted into the human body for a surgical or medicinal reason and is intended to stay there after the surgery. They are useful for activating physiological organs or detecting a physiological response in vivo.
For instance, implanted insulin pumps, hip implants, intraocular lenses, and coronary stents
Define Active Implantable Device?
Active Implantable Devices are any powered medical devices that are implanted into a person's body for either diagnostic or therapeutic reasons with the intention of remaining there. They are regarded as gadgets with the greatest risk categories and need to pass a strict regulatory review before being put on the market.
For instance, implantable cardioverter-defibrillators, implantable neurostimulator systems, implantable accessories for brachytherapy systems, etc.