Medical Device CE Marking stands for Conformité Européenne and this is a legal requirement to place the medical device on the market in Europe. CE mark shows conformity with the European Union Harmonization Legislation and EU Medical Device Regulation.
In order to be CE marked or CE labelled, firstly, medical device should comply with the ‘general safety and performance requirements’ laid out in Annex I of MDR or IVDR. Secondly, medical device must undergo conformity assessment procedure based on its classification and risk.
REGhelps team of consultants provide complete support for new Medical CE Marking or migration from MDD/IVD to MDR/IVDR

MDR and IVDR CE marking Process
In order to commercialize medical devices in the EU market, CE mark is a requirement in compliance with the EU regulations, that is MDR 2017/745. Following are the processes to attain CE mark:
- 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 your Medical Device
- Prepare a Declaration of Conformity [DoC] with the applicable regulations and affix CE mark 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
Similarly, in order to market IVDs in the EU market, again the CE mark is a requirement in in the EU Regulations, that is IVDR 2017/746. Following are the processes to attain CE Marking
- Appoint a person responsible for regulatory compliance
- Determine classification of your device using Annex VIII of IVDR (Class A -specimen receptacles, Class B- Pregnancy Tests, Class C-Companion Diagnostics, Class D- Blood Screening)
- Implement Quality Management System according to ISO 13485
- Prepare a Technical File based on the IVDR which includes the files of Risk Management, Clinical Evidence – Scientific Validity, Analytical Validity, Clinical Performance.
- Obtain a Unique Device Identifier (UDI) for your IVD
- Appoint a European Authorized Representative
- Submit the Technical File to the Notified Body and get the QMS audited by them
- Attain CE certificate for your IVD and ISO 13485 certificate for your facility
- Prepare a Declaration of Conformity [DoC] with the applicable regulations and affix CE mark on your IVD
- Register the medical device and the UDI in the EUDAMED Database and add the UDI on the label of your IVD
- Place your IVD in the market and start the Post Market Surveillance Activities
- Notified Body will audit yearly to check the compliance of the device with IVDR. Update your PMS and PMCF to maintain the CE mark
Role of Consultants in CE marking
REGhelps 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.
REGhelps 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 templets as the regulatory requirements.

- Make sure that the Notified Body is designated for the services required by you.
- Identify the scope of services of the potential Notified Bodies
- Confirm if the Notified Body that you have selected provides certification for the quality system along with certification of conformity assessment
- Check for the capability of a Notified Body to provide services that apply to regulatory jurisdictions outside Europe
- Inquire the audit method and regarding the stringency of the Notified Bodies before the selection to avoid risk to patients and medical device manufacturers
- Select the Notified Body at the earliest especially if the medical device is complex or if its regulatory status is not straightforward, which can occur with drug-device combination or borderline products
- Carefully review the contract between you and the Notified Body
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)
According to MDR 2017/745, ‘Clinical Evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
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The Technical Documentation or the Technical File refers to all the documents that the medical device manufacturers need to submit to the notified body as per the MDR or the IVDR.
The major contents of a technical documentation are:
- Identification of the medical device or the IVD (E.g.: UDI)
- Description of the device, including variants, configuration and accessories
- Intended purpose
- Labelling (Packaging, IFU etc.)
- Information on the design and manufacture
- Risk Management File
- Verification (Stability, Electrical safety tests reports and certificates and so on) and Validation (Clinical Evaluation, Biological Evaluation etc.) to prove that the medical device/IVD meets the general safety and performance requirements.
When you need to budget for medical device CE Marking, the following cost should be considered
- 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
- Better understanding of your medical device and its applicable regulatory requirements faster than anyone
- Always have prior experience in handling similar Medical Devices
- Provide guidance and support in preparing Technical File /Design Dossier
- We are experienced medical writers for developing clinical evaluation report as per MEDDEV 2.7/1 Rev. 4
- Support in conducting the Risk Analysis and Usability Records
- Experienced in Quality Management System implementation as per ISO 13485:2016
- Identifies the applicable Harmonized standards
- Have the necessary knowledge and expertise to review and comment external test reports
- Reviews verification & validation documents and labels as per ISO 15223-1
- Identifies the class and applicable rule of Medical Device
- Can identify the main route of CE Marking
- Well-experienced in preparing the Declaration of Conformity
- Helps with identifying the Notified Body
- Supports during certifications and annual surveillance audits
- Others supports such as:
- Guidance on Implantable, Active Implantable, Animal Origin & Drug Device combination products
- Technical support for IVD Device
- Electro-Mechanical and ROHS, PED combination Devices as per 2007/47/EC.
- Software CE Marking
The EU Authorised Representative (E.A.R) is your link to European authorities, and they must have physical presence in Europe. They will enrol your medical device or IVD before it is marketed and will always be available to serve as a contact between you and the Competent Authorities of the EU member states. Your (E.A.R) will also have access to your Technical Documentation(s), which must be available for inspection by the Competent Authorities. In other words, a variety of the responsibilities of the manufacturer are delegated to the EU Authorised Representative.
By supporting on attaining the CE mark and QMS implementation, consultants play very crucial roles in assuring CE certificate from the Notified Bodies.
Yes, the Consultants guide the manufacturers by informing which harmonized standard testing has to be done and which Labs are to be approached.
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As the conformity assessment routes include both design verification and validation review, the ISO 13485 Quality Management System for both- products and processes, can help manufacturers to attain the required systems in place even before pursuing the CE mark for the European market. Medical Device manufacturers operating outside the European market that already have a Quality Management System based on ISO 13485 can more easily obtain the CE mark for their medical devices or IVDs, as many of the directives’ conformity assessment review requirements are already met through implementing the ISO 13485 standard. In some medical devices (manufactured via ISO 13485-compliant systems), a certificate of declaration of conformity by the manufacturer is enough to attain a CE mark.
Consulting firms are specialized in document drafting, training, supporting, review and Internal auditing for all manufacturing and related services to ensure full compliance to the EN ISO 13485:2016 standard. In addition, Consulting firms can create paper systems, electronic systems, or even web-based documentation control system which may be accessed from anywhere in the world and can be tailored to your organizational structure and requirements.
Consulting companies focus mainly on medical device and IVD companies, so they understand the unique needs and manufacturing scenarios of the industry. Most of the ISO 13485 consultants are EN ISO 13485:2016 lead auditors and approved internal auditors.
ISO 13485 consultants customize your ISO 13485 quality system to meet your organizational specific needs and make sure you are ready for ISO 13485 certification audit from a Certification Body.
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”.
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Yes, the consultants will visit the client location
No, the consultants do not help with device design.
Yes, the company is ready to sign an NDA with the client.