Medical Devices
CE Marking according to the Medical Device Regulations (EU) 2017/745 and (EU) 2017/746 (MDR and IVDR)
Certification Experts is your full-service compliance partner and guides you through the complete CE marking procedure for medical devices. With over 25 years of experience, our team of 15+ specialists will help you to obtain access to the EU-, UK- and Swiss markets.
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Trust our Medical Team to support you with the conformity assessment procedure
CE Marking for Medical Devices: from the Directives to the Regulations
The Medical Device Directives 93/42/EEC (MDD) and 98/79/EEC (IVDD) have been replaced by the Medical Device Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR). This means that existing medical devices that have been CE marked under the Directives need to be reassessed under the new Regulations. Important changes:
- New definition of a medical device and the inclusion of certain products without a medical purpose.
- Extended risk classification rules.
- The General Safety and Performance Requirements (GSPR) have been expanded.
- The implementation of a Unique Device Identifier (UDI) has been made mandatory.
- The requirements for the Quality Management System (QMS), the Clinical/ Performance evaluation and the Post Market Surveillance (PMS) have become stricter.
- Registering your contact details and devices in EUDAMED, the EU database for medical devices.
- Specific requirements for importers and distributors.
- Appointing a Person Responsible for Regulatory Compliance (PRRC).
Medical Device Regulations (MDR and IVDR)
Certification Experts as your full-service compliance partner
Since May 26, 2021, the Medical Device Regulation (EU) 2017/745 is in effect, followed by the In Vitro Medical Device Regulation (EU) 2017/746 which came into effect on May 26th, 2022. Previously, the Directives were in force. The Medical Device Coordination Group (MDCG) has produced guidelines to make the transition to the Medical Device Regulations manageable. These MDR European Commission guidelines are not legally binding but support a uniform implementation and application of the Medical Device Regulations. Based on the Regulations and these guidance documents, the Certification Experts team can help you implement the changes:
| New guidelines | Our solution |
| New definition of a medical device and the inclusion of certain products without a medical purpose & extended risk classification of the Medical Device Regulations in the EU. | Our experts can assess your product so that you will know if the product is regulated as a medical device, and if so, which Classification Rules apply and in what Risk Class it should be classified. |
| The General Safety and Performance Requirements (GSPR) have been expanded. | Based on (harmonised) standards, we can consult you in achieving compliance with the General Safety and Performance Requirements so that you will be able to demonstrate conformity. |
| Implementation of a ‘Unique Device Identifier’ (UDI) has become mandatory. | Our team can supervise a correct implementation of the UDI for you. |
| Requirements for the Quality Management System (QMS). | We can help to implement an appropriate QMS from start to finish. |
| Clinical/ Performance Evaluation and Post Market Surveillance (PMS) have become stricter. | Our clinical experts can write and guide you with the clinical evaluations and the handling of Post Market Surveillance. |
| Registering your contact details and devices in EUDAMED, the EU database for medical devices. | We can assist you with registering yourself and your medical devices in the Eudamed database. |
| It is mandatory for all manufacturers whose products are regulated as a medical device to affix the CE mark for medical devices before these devices are placed on the Union Market. The admission requirements vary per risk class. | Our expertise lies in guiding you in the conformity assessment procedure for your devices. |
If you would like to know more, Certification Experts can evaluate your current CE marking and provide expert consultancy services under the regulations. This is done through the following steps by our experts:
- An assessment of your device to determine the applicable Regulation and the correct Risk Class
- A GAP analysis of your current Technical Documentation to determine the Route to Compliance
- Supporting and guiding services to help you to establish the Technical Documentation
Full-service MDR compliance
What are the ISO standards for medical devices?
There are several ISO and IEC standards for medical devices. Using the harmonized standards gives a presumption of compliance with the General Safety and Performance Requirements. The most commonly applied standards are ISO 13485 (Quality Management), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), IEC 62304 (Software), ISO 14155 (Clinical Investigation), ISO 15223 (symbols on the label/IFU) and IEC 60601 (Electrical Safety). We can assist you with your questions about ISO and IEC standards for medical devices.
Also learn all about our authorized representative for medical devices.
MDR compliance & certification
To be in compliance with the Medical Devices Regulations, you will have to comply with stricter requirements than known under the Directives. Among others, you must draw up a new Technical Dossier, implement a Quality Management System under ISO13485 and, if your product falls into a higher risk class, have your device assessed by a Notified Body in order to be able to market your devices in the EU. You can learn more about the CE medical abbreviation here. The Medical Device Regulations will make the market more transparent and it will be more difficult to trade unsafe medical devices. This way, the Regulations protect the safety of the users. Certification Experts can help you to establish the Technical Dossier and Quality Management System, allowing you to place your medical devices on the Union market.
We will start with the risk classification of your device, and discuss with you the most appropriate conformity assessment procedure. With our expertise, we can tailor the lengthy and extensive procedure with many different steps, into a clear and efficient process for you.
Medical devices regulation guidance from start to finish with Certification Experts
In addition to our regular consulting services, our experts can also support you with the dynamics in the processes and actions required by the Regulations, such as:
- Generating UDI’s
- Writing and maintaining the Clinical Evaluation report
- Maintaining the Post Market Surveillance system
- Offering support with Risk Management
- Designing labels and manuals
- Maintaining your Quality Management System (QMS)
With Certification Experts as your full-service Compliance partner:
- You have accelerated access to the Union Market
- You will be guided by a team of Medical Device experts
- You will work with a trusted party with 2000+ satisfied customers
Are we the partner to cope with the EU Medical Devices Regulations you have been looking for?
Is a CE mark needed for Medical Devices?
CE marking of medical devices is mandatory. Before you can start the procedure, it is necessary to determine whether your product is regulated as a medical device. The definition for a medical device under Medical Device Regulation (EU) 2017/745 is: any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific CE meaning medical purposes:
- Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
- Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state
- Providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
The following products shall also be deemed to be medical devices:
- Devices for the control or support of conception
- Products specifically intended for the cleaning, disinfection or sterilisation of devices
Further, there are several products that do not fit in the definition of a medical device, but are regulated as a medical device by decision, such as liposuction devices, fillers etc.
The definition for a medical device under the In Vitro Medical Device Regulation (EU) 2017/746 is: any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
- concerning a physiological or pathological process or state
- concerning congenital physical or mental impairments
- concerning the predisposition to a medical condition or a disease
- to determine the safety and compatibility with potential recipients
- to predict treatment response or reactions
- to define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices
Note that the definition of an in vitro medical device starts with the requirement that it is a medical device as per the definition of (EU) 2017/745
Based on the intended use, it needs to be determined which classification rules are applicable to the device. If the product is defined as a medical device, the risk classification determines which conformity assessment procedure needs to be followed. The conformity assessment procedure involves the Technical Dossier and the implementation of a Quality Management System (QMS). Furthermore, where applicable, it is required to a involve a Notified Body in the conformity assessment. Upon a successful assessment, you will receive a CE certificate.
Low risk devices are subject to selfdeclaration. Contact us for details.
What risk classes are there?
Defining the risk classification of your device is an essential part of the CE marking procedure for medical devices. As indicated, based on the intended use, it is determined which classification rules apply to your device, and hence, in which risk class the device falls. The conformity assessment procedure is subject to the risk classification. Due to the changes in the risk classification rules, it is possible that under the Regulations, your device falls in a different risk class than under the Directives. The following table provides an overview of all classes.
Classification of devices
| Class | Example | Notified Body Involvement |
| MDR Class I – Low risk medical devices | Spectacles, sports tape | None |
| MDR Class Is – Sterile low risk medical devices | Sterile single-use syringes | Focuses on aspects related to establishing, securing, and maintaining sterile conditions |
| MDR Class Im – Low risk medical devices for measuring | Clinical thermometers, droppers, non-evasive blood pressure measuring device | Ensures compliance with metrological requirements |
| MDR Class Ir – Reusable low risk surgical invasive medical devices | Non invasive instruments such as resuable clamps, clips, drills, scissors, saws | Assesses aspects related to device reuse, including cleaning, disinfection, sterilization, maintenance, functional testing, and the associated instructions for use |
| MDR Class IIa – Medium risk medical devices | Pelvic floor muscle trainers, most Medical Device Software (MDSW) | Assessment according to the conformity procedure |
| MDR Class IIb – Medium to high risk medical devices | Blood bags, urethral stents, dental implants, penile implants | Assessment according to the conformity procedure |
| MDR Class III – High risk medical devices | Prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders | Assessment according to the conformity procedure |
| IVDR Class A | Urine Specimen Container, Neutral Buffered Formalin, Cytology Staining Solutions | None |
| IVDR Class A sterile -Low Risk sterile devices | Sterile general culture media, Sterile specimen container | Focuses on aspects related to establishing, securing, and maintaining sterile conditions |
| IVDR Class B- Medium risk medical devices | Vitamin assay, Viral DNA/RNA Extraction kit, H. Pylori Rapid Test kit | Assesses the technical file and the quality management system and issues a CE Certificate |
| IVDR Class C- – Medium to high risk medical devices | Herpes Virus PCR Kit, Dengue & Chikungunya PCR Kit, Trisomy Detection Software | Assesses the technical file and the quality management system and issues a CE Certificate |
| IVDR Class D – High risk medical devices | HIV Test Kit, Hepatitis B diagnostic kit, Blood Group System | Assesses the technical file and the quality management system and issues a CE Certificate |
Certification Experts can help you to determine the risk class of your device.
How can I start the CE marking process for Medical Devices?
When you want to put a medical device onto the Union Market, you need to establish the Technical Dossier and implement a QMS (ISO 13485), decide upon the conformity assessment procedure and take into account the CE mark labelling requirements for medical devices; consider the GSPR, EUDAMED, UDI, PMS, clinical trial etc. If you are located outside of the EU, and you want to put your device onto the European market, you need an Authorised Representative (EC REP) to act as a liaison between you and the competent national authorities. Since the medical devices directives are replaced by the medical devices regulations, CE marking can be quite a prolonged and demanding process. Our team of experts has the know-how to manage this process for you.
Medical devices that are currently being sold on the UK market may be CE marked. If necessary, our experts can also help with UKCA marking. If you are a medical device manufacturer based outside the UK and wish to place your medical devices on the UK market, you are required to appoint a UK Responsible Person (UKRP) for all of your devices. We can act as your UK Responsible Person (UKRP) and register your device with the MHRA (Medicines and Health Care products Regulatory Agency).
If you’re not only looking for medical device CE marking, it is also possible to assist with the CE marking for electrical equipment of your company.
We can also help you with all your questions about the MDR article 10.
Full-service MDR compliance
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Discover how our experts can assist you in achieving compliance for your medical devices.
Medical Device Regulation (MDR)
The Medical Device Regulation (MDR) 2017/745 and In Vitro Medical Device Regulation 2017/746, effective since May 26, 2021 and May 26, 2022 respectively, impose stricter requirements on medical device manufacturers. Certification Experts, with over 25 years of experience, can assist with your compliance to these regulations.
- Risk classification of medical devices
- GAP Analysis MDD/ MDR and IVDD/ IVDR
- GAP Analysis QMS
- Templates Technical File and QMS
- Guidance, implementing and assessing QMS
- Guidance and/or Review Technical File
- EC Rep / UKRP
- PRRC
- Risk Management
- Consult with Expert
CE Marking
The CE mark serves as proof that a product complies with European product regulations. It’s a mandatory requirement for manufacturers whose products fall under applicable CE directives and regulations before they can enter the European market. Additionally, other parties like importers, distributors, and authorized representatives have their roles in ensuring that products bear the CE mark. Obtaining CE marking can be a complex and time-consuming endeavour. It involves understanding the regulatory requirements, accessing the necessary testing facilities, and managing time effectively. Our team of CE mark consultants is here to support you throughout this process. We’ll guide you to conduct the required testing, and simplify the path to the CE marking of your products. As your dedicated compliance partner, we aim to streamline this often intricate procedure.
- Conformity Assessement procedure
- Technical Dossier
- Risk Assessment
- Inspection/Safety Assessment
- Testings
- Declaration of Conformity
- Authorised Representation
EC Rep
According to the Medical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU) 2017/746) you are obliged to appoint a European Authorised Representative (EC REP) if you want to trade your Medical Device(s) on the European market. AR Experts (part of Certification Experts) can act as an EC REP on behalf of your organisation.
- Aid in CE marking conformity assessment procedure
- Authorised representative agreement/mandate
- Technical Dossier and Documentation review
- Acting as a contact person with the competent authorities
- Provide regulatory advice
Training medical devices
Certification Experts offers training programs for CE marking and Quality Management Systems (QMS). This provides you with the knowledge on how to enter your medical device safely into the EU Market.
- Quality Management System ISO 13485
- Medical Device Certification (MDR and IVDR)
- Software IEC 62304
- Technical Documentation
- GDP Training
ISO 13485
Our team of experts can aid in helping you to implement a ISO 13485 QMS and ensure that your company meets the requirements that ensure that your medical devices and services consistently meet customer expectations and relevant regulatory requirements.
- Gap Analysis
- Set up a quality system
- Implementation session with presentation
- Training ISO 13485, risk management and internal audit training
- Internal audit
- Support with certification audit
- Maintenance of QMS
Route to Compliance / Classification
For every market, Certification Experts can provide a practical compliance roadmap. This will ensure your access to any chosen market in the most time and cost-efficient way. This service can entail a classification of relevant Product Safety requirements, an assessment of the product, an analyse of the design, a verification of the used components, materials and a determination of the potential risks associated with its use.
- Determining how the applicable product legislation applies to your product
- Describing the steps of the conformity assessment procedure
- Determining roles and responsibilities of the parties involved
- Setting up test procedures
Affiliate Notified Body Services
For higher risk products, the technical documentation must be reviewed and tested by a Notified Body (NoBo). Affiliate Notified Body Services involve organisations collaborating with designated Notified Bodies. This provides expertise, supplementary services, or support for product testing and certification and as a result, streamlines processes and enhances certification capabilities, ensuring products meet EU regulations. Certification Experts can guide this process and submit the documentation to the Notified Body, ensuring that the file is complete before the certification procedure.
- Search and selection of Notified Bodies
- Request quotations from a Notified Body
- Guidance with application process of a Notified Body
- Supervising the assessment process
UK Responsible Person (UKRP)
As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom as their UKRP.
- UKRP agreement/mandate
- Technical Dossier and documentation review
- Technical Dossier and documentation review
- Providing regulatory advice
- Registration of your devices at the MHRA
QMS
CE Medical can set up, implement, review and maintain a Quality Management System (QMS) for your organisation. We provide an appropriate QMS based on your situation and wishes.
- ISO 13485
- ISO 9001
- Article 10 Quality Management System MDR
Registration Medical Device
Medical device registration is mandatory under the Medical Device Regulations to facilitate a safer and transparent market for the benefit of the users. Certification Experts can guide you with the registration of your medical devices in EUDAMED for Europe, and in DORS at the MHRA.
- Classify your product
- Register as your EC REP/UKRP and you as manufacturer
- Obtain the correct marking for your product
- Guiding the UDI process and guidance with the registration of your products in EUDAMED, or with the MHRA
EUDAMED + UDI
CE Medical can assist you with registration of your devices in EUDAMED and with the arrangements for a UDI. EUDAMED is a European database for medical devices. Regulation (EU) 2017/745 on medical devices and regulation (EU) 2017/746 on vitro diagnostic medical devices introduce an EU device identification system. It is based on a unique device identifier (UDI) and allows for easier traceability of medical devices. This requires that manufacturers submit in EUDAMED the UDI/Device information of all devices they place on the EU market. Importers, authorised representatives and system/procedure packers must also register in EUDAMED.
- Registering in EUDAMED as an Authorised Representative (EC REP)
- Guidance with EUDAMED registration of your company and medical devices
- Guidance with UDI System
Certificate of Free Sales
A Certificate of Free Sale (CFS) is a statement by a Union CA that a device is duly on the EU market. A CFS facilitates market access to third countries (other regions in the world). As Authorised Representative, AR Experts can submit an application to the Dutch Competent Authority to issue a CFS for you.
- Submit application
- Legalisation at the Ministry of Justice
- Endorsement by the Embassy of the destination country
PRRC
Certification Experts can offer to act as a Person Responsible for Regulatory Compliance (PRRC) in the context of medical devices. The PRRC is a crucial position mandated by the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure compliance with regulatory requirements for medical devices and in vitro diagnostics. Certification Experts can also act as a Deputy PRRC. A Deputy PRRC, or Deputy Person Responsible for Regulatory Compliance, is an individual appointed by a medical device or in vitro diagnostic device manufacturer to assist their PRRC in fulfilling the duties related to regulatory compliance.
- PRRC
- Deputy PRRC
- Guiding PRRC and/or Deputy PRRC
Risk Management
The Medical Device Regulations in Europe have a strong emphasis on Risk Management. Herein, manufacturers of medical devices must identify foreseeable risks and implement risk mitigation measures throughout the design and production process. However, it is important to note that assessing the risks does not end there, as ISO 14971:2019, titled “Medical devices – Application of risk management to medical devices” requires companies manage risks as an ongoing internal process that lasts throughout a medical device’s product life cycle.
- Execution of the risk assessment
- Guidance in performing a risk assessment
GAP Analyses
A GAP analysis based on product specific regulations is a structured assessment that identifies the differences or “gaps” between a company’s current practices and the requirements stipulated by product safety regulations. This type of analysis helps organizations ensure that their products are compliant with the relevant safety standards and regulations. Certification Experts can carry out a GAP analysis based on the specific requirements for organisations to ensure that their products meet safety standards and remain compliant with regulatory requirements. It helps mitigate risks, ensures consumer safety, and safeguards a company’s reputation in the marketplace.
- Regulatory Framework Identification
- Current Practices Assessment
- Regulatory Requirements Evaluation
- Gap Identification
- Prioritisation
- Plan of Action
Certificate of Free Sales
A Certificate of Free Sale (CFS) is a statement by a Union CA that a device is duly on the EU market. A CFS facilitates market access to third countries (other regions in the world). As Authorised Representative, AR Experts can submit an application to the Dutch Competent Authority to issue a CFS for you.- Submit application
- Legalisation at the Ministry of Justice
- Endorsement by the Embassy of the destination country
All the answers you might need!
The time required to obtain a CE mark for medical devices varies based on factors such as device classification, chosen conformity assessment route, preparation of documentation, Notified Body involvement, regulatory changes, manufacturer’s experience, timeliness of communication, availabilty, et cetera.
Generally, the process can takes up to a year, ranging from several months for Class I devices to over a year for devices requiring Notified Body assessment. Manufacturers should initiate the process well in advance to account for potential delays and ensure a smooth certification process.
If your product falls within the scope of the Medical Devices Regulations, CE marking is mandatory. With the Regulations, the rules have been tightened, and as a result, you must provide more evidence for the compliance.
If the product does not fall within the scope of the Medical Device Regulations, you will have to check if there are any other relevant Directives or Regulations. Other legislation may lead to CE marking as well; if not, it is even prohibited to apply the CE marking to your product.
In the context of the Medical Devices Regulations, the certification of your ISO 13485 quality system is not a mandatory element. While the Regulations do not explicitly mention ISO 13485, it does mandate the implementation of a Quality Management System. The EU has outlined a set of harmonised standards to guide companies in complying with the applicable requirements for medical devices in the EU. Notably, ISO 13485:2016 is the sole quality management standard listed, making it kind of mandatory for all medical devices.
Classifying your product is essential for defining the conformity assessment procedure. Medical device classes refer to mapping of medical devices based on their level of risk and the regulatory controls necessary to ensure their safety and effectiveness. In the European Union, medical devices are classified into Class I (Is, Im, Ir), Class IIa, Class IIb and Class III, based on the risk associated with their use. The classification is typically based on factors like body contact, invasiveness, administrating substances or energy, diagnostic capabilities, powered by an energy source, medicinal ingredients etc. Manufacturers must adhere to specific regulatory requirements based on the assigned risk class to ensure patient safety and device effectiveness.
Class I
- Defintion: Medical devices with low risk
- Examples: glasses, sports tape
Class Is
- Definition: Sterile medical devices with low risk
- Examples: sterile disposable syringes
Class Im
- Definition: Medical devices with a measurement function
- Examples: digital thermometers, droppers, non-invasive blood pressure monitors
Class Ir
- Definition: Reusable surgical devices
- Examples: non-invasive instruments like clamps, clips, drills, scissors, saws
Class IIa
- Definition: Medical devices with medium risk
- Examples: trainers for pelvic floor muscles, most Medical Device Software (MDSW)
Class IIb
- Definition: Medical devices with medium to high risk
- Examples: blood bags, urethral stents, dental implants, penile implants
Class III
- Definition: Medical devices with high risk
- Examples: prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders, devices containing supportive medicinal ingedients
A Notified Body is an organisation that is designated by a Competent Authority to assess the conformity of higher risk class medical devices, before being placed on the Union Market. Notified Bodies play a vital role in the regulatory processes for various products, including medical devices, as well as other sectors such as machinery, personal protective equipment, and more. These bodies carry out tasks that are related to conformity assessment procedures set out in the applicable legislation.
Notified Bodies operate independently and are designated by EU member states’ Competent Authorities. The European Commission maintains a comprehensive list of Notified Bodies, and each Notified Body is assigned a unique identification number. The designation process involves demonstrating the competence and impartiality of the organization.
It’s important to note that the involvement of Notified Bodies is specific to certain regulatory frameworks, such as the Medical Devices Regulations in the EU. The specific requirements and procedures can vary based on the type of product and the applicable regulations.
A Risk Management System for medical devices is a structured and systematic approach to identify, assess, control, and monitor risks associated with the entire lifecycle of medical devices. Guided by standards like ISO 14971, it involves the systematic identification of potential hazards, evaluation of risks, implementation of control measures, clear communication about residual risks, ongoing monitoring, comprehensive documentation, and integration with the Quality Management System of the manufacturer. The objective is to proactively manage risks to ensure the safety and performance of medical devices, meeting regulatory requirements and addressing potential concerns throughout the product lifecycle.
The EU MDR and IVDR are Regulations that are mandated by the European Parliament, that dictate what needs to be done by an organisation before putting a medical device on the Union Market.
ISO 13485 is an internationally recognised standard for the implementation of a Quality Management System for medical device companies around the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.
The EU MDR and IVDR are Regulations that are mandated by the European Parliament, that dictate what needs to be done by an organisation before putting a medical device on the Union Market.
ISO 13485 is an internationally recognised standard for the implementation of a Quality Management System for medical device companies around the world. Using ISO 13485 as a standard will enable any organisation to illustrate that their products meet customer and regulatory requirements.
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