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CE marking for medical devices

Services according to the Medical Device Regulation (MDR) 2017/745

Certification Experts can be your full-service compliance partner and guide you through the complete CE marking process for medical devices. With over 25 years of experience, our team of 15+ specialists will help you to obtain access to the EU/UK market. 

CE mark medical devices

The CE mark for medical devices is by definition the mark that indicates that your medical device is in compliance with the European product legislation. It is mandatory for all manufactures whose products fall within the Medical Device Regulation 2017/745, to get CE certification for their medical devices before they can access the European market.

Challenges of CE certification

Obtaining CE approval for medical devices can be a complex and lengthy process. This is because it requires for you to implement both a conformity assessment procedure according to the MDR, wich requires you to consider the GSPR, Risk Management, EUDAMED, UDI, PMS, clinical evidence etc., and a Quality Management System (ISO 13485).

Guidance from start to finish

Our experts can guide you through all processes and help you implement all necessary procedures as required by Medical Device Regulation 2017/745. As your full-service compliance partner, we can take the burden of getting CE medical device certification off your team.

Let our dedicated
Medical Team
handle the CE marking process for your medical devices

Guidance under the new regulations: from MDD to MDR 

What was previously known as the Medical Device Directive (MDD) 93/42/EEC has been replaced by Medical Device Regulation 2017/745 (MDR). This means that existing medical devices that have been CE marked under the MDD need to be recertified under the new regulation. The following has changed: 

  • More medical devices are subjected to the new regulation due to a new definition of ‘medical device’. 
  • The classification rules are stricter. 
  • The General Safety Performance Requirements (GSPR) have been expanded. 
  • Implementation of Unique Device Identifier (UDI) has been made mandatory. 
  • The requirements for the Quality Management System (QMS), the Clinical Evaluation and the Post Market Surveillance (PMS) have become stricter.  
  • It is now mandatory to register both the manufacturer and the devices in EUDAMED, an European database Medical Devices. 

How can I start the CE marking process for medical devices? 

For medical devices, CE marking is mandatory, but before you can get your device marked, it is necessary to determine whether your product falls within Medical Device Regulation 2017/745. Based on the intended use and the medical claims, it needs to be determined whether the classification rules are applicable to the device. If the product is defined as a medical device, it will be classified, which then determines what conformity assessment procedure needs to be followed. To then start the procedure of obtaining CE marking for medical devices, you need to compile a technical file, apply with a Notified Body (NoBo) and implement a Quality Management System (QMS). 

What classes are there? 

Classifying your product is an essential part of the CE certification for medical devices. Because of the transition from MDD to MDR, it is possible that your product currently falls within a different class than it might have previously. The following table provides an overview of all classes.  

Classification of devices 

Definition 

Examples 

Class I 

Low risk medical devices 

Spectacles, sports tape 

Class Is 

Sterile low risk medical devices 

Sterile single-use syringes 

Class Im 

Low risk medical devices for measuring 

Clinical thermometers, droppers, non-evasive blood pressure measuring device 

Class Ir 

Reusable low risk non-invasive surgical medical devices 

Non invasive devices such as clamps, clips, drills, scissors, saws  

Class IIa 

Medium risk medical devices 

Pelvic floor muscle trainers, most Medical Device Software (MDSW) 

Class IIb 

Medium to high risk medical devices 

Blood bags, urethral stents, dental implants, penile implants 

Class III 

High risk medical devices 

Invasive devices such as prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expanders, custom made devices.

Certification Experts can help you to determine the class of your device. 

Procedure CE mark medical devices 

When you want to bring a medical device onto the market, you need to implement both a conformity assessment procedure and a QMS (ISO 13485); take into account the CE mark labelling requirements for medical devices; and consider the GSPR, EUDAMED, UDI, PMS, clinical trial etc. If you are located outside of the EU, and you want to bring 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. Because the MDD has been replaces by the MDR, obtaining CE marking for your medical device can be quite a prolonged and demanding process. Our team of experts has the know-how to manage this process for you.

International product marking: FDA and UKCA 

Food and Drugs Administration (FDA) is a federal agency for medical devices within the USA. Part of their responsibility is the regulation of market access of medical devices and monitors the safety requirements of all medical products. The MDR is more in line with the FDA than the MDD was.Certification Experts can perform a GAP analysis of FDA approved documentation, which is part of the technical documentation necessary for the CE marking process.

Because of Brexit, medical devices that are currently being sold on the UK market need to be UKCA marked, instead of CE marked. Our experts can help you obtain UKCA marking for all class I medical devices. We can additionally act as your UK Responsible Person (UKRP) and register your device with the MHRA. 

INSIGHT

What is the Medical Device Regulation (EU) 2017/745?

INSIGHT

What is a Declaration of Conformity?

INSIGHT

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Certification Experts
offers the following services

Click on the service blocks bellow to see what our experts can do to help you obtain the CE mark for your medical devices.  

Classification
MDR Compliance
Quality Management System (QMS)
Technical Documentation
Product Testing
Clinical Evaluations
Authorised Representative (EC REP) and UK Responsible Person (UKRP)
Notified Bodies (NoBo)
EUDAMED + UDI
Training

CE/UKCA marking for medical devices with our proven process

01 - Classify

the legal framework for your medical device

02 – Assemble

the technical file

03 – Implement

the conformity assessment procedure (with a NoBo) & a QMS

04 – Register

the medical device in EUDAMED, Notis or/and MHRA

05 – Establish

your Post Market Surveillance System

01 – Identify
the legal framework for your medical devices
02 – Determine
the route to compliance
03 – Perform
the conformity assessment procedure
04 – Marking
can be affixed and the certificate signed
05 – Ship
your product worry-free to the desired market
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What our clients are saying about us

Van Heek Medical
Wilma Peereboom
Quality Coordinator
The cooperation with CE goes satisfactorily. They were decisive from the start and things were well taken care of. I see the problem-solving capacity of Certification Experts as a strength of the company’.
6 weeks
Europe
Medical
Confocal
Peter Drent
CEO
Personally I am very satisfied with the service and quality of the work of Certification Experts. With future projects, I certainly intend to work with them again.
3 weeks
Europe
Electronics
Gallery Play Media
Ruben Kieftenbelt
Founder & CTO
The test results during the certification project were comprehensive and detailed. We experienced this as a pleasant and valuable result. In addition, Certification Experts swiftly came up with solutions for obstacles we encountered during the certification process.
4 weeks
Europe
Electronics
Adtrack Media
Paul East
CTO
We have found Certification Experts to be helpful, knowledgeable and prompt even during the difficult environment due to the COVID-19 pandemic. We look forward to working with Certification Experts on future projects.
4 weeks
Europe
Electronics
Nikon
Joachim Hofmann
GM Service & Support
We found the collaboration with the CE Team very helpful, professional, fast and flexible. It is always good to have a partner at hand who can help with profound expertise whenever required. In the future, CE will stay our choice if expert-know-how is needed.
4 weeks
Europe
Electronics
Physee
Wai-Man Tang
Quality Assurance Manager
We have a wonderful experience working with Certification Experts. We are a scale-up doing product developments under a very tight timeline. Certification Experts will adjust to our needs and guides us step by step to complete our product certifications in time.
3 weeks
Europe
Electronics
Oceanteam
Lars van ‘t Kruijs
Managing Director
The team of Certification Experts consists of nice people, it was a good cooperation! For me it was important how they made everything clear and how they thought along the same lines.
3 weeks
Europe
Machinery
Alfa Wasserman
Kurt Spiegel
Engineer Manager
CE has been our partner for over 10 years and the relationship is outstanding. The face-to-face meetings are really important and save us a lot of time.
6 weeks
Europe
Medical
Dot Robot
Edward Belderbos
Technical Director
It was a pleasure to work with Certification Experts. After reviewing our documentation, they gave us structured feedback and showed us a way forward to compliance with EU directives
3 weeks
Europe
Electronics
Noffz
Markus Solbach
Director Sales & Marketing
Certification Experts has a great service with high flexibility and really quick response time. We were impressed with their good technical understanding and detailed feedback to our complex test solution in a short timeframe.
4 weeks
North America
Electronics
Government of Canada
Melanie Ter Meulen
Trade Commissioner
The collaboration with Certification Experts runs smoothly and they are a valuable partner for us. If Dutch companies require specific technical information about the Comprehensive Economic & Trade Agreement on free trade, Certification Experts is the first to call.
2 weeks
Europe
Medical

Expert insights

Full-service product compliance without the headaches.

Leave it to us.

Classification

CE Medical can check if your device falls within the scope of the MDR. Under the MDD and MDR devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to their risk: starting from class I for the lowest-risk devices to class III for the highest. We can classify the device based on its intended use. Due to the transition of the MDD to MDR, a medical device can fall within a higher class. Our experts can determine whether this impacts the classification of your device. The classification decides the further conformity assessment route. 

  • Class MDR; I, Ir, Im, Is, Ila, Ilb and III
  • Check intended use and medical claims
  • Guidance with determining medical claims
  • Verifying the feasibility of medical claims
  • Review of the classification rules
  • Establishing the conformity procedure
MDR Compliance

CE Medical will help you enter the European Market with your medical device. We offer complete certification guidance and expert services in order to ensure your medical device is compliant with the CE marking legislation. Additionally, we can ensure that your organisation has a Quality Management System (QMS) in place.

  • Classification
  • Implementation and supervision of the conformity procedure
  • Implementation and supervision of QMS
  • Support with the General Safety Performance Requirements (GSPR)
  • Support with technical documentation
  • Guidance with EUDAMED and UDI
  • EU Declaration of Conformity and CE Marking
  • Support in Post Market Surveillance (PMS).
Quality Management System (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
Technical Documentation

Every manufacturer requires a technical file to be able to demonstrate the device’s compliance. CE Medical can prepare technical documentation, along with providing support, compiling and reviewing the required technical documentation for you.

  • Establishing product description and technical specifications
  • Providing checklists and templates for product labelling
  • Checking and supervising the preparation of the user manual (Instructions for Use- IFU)
  • Drafting the architecture of the design of the medical aid
  • Ensuring the compliance of the manufacturing processes
  • Drafting risk management
  • Providing checklist General Safety Performance Requirements (GSPR)
  • Support with clinical evaluation
  • Checking and drafting Post-Market Surveillance (PMS) plan, Post Market Clinical Follow (PMCF) plan and Periodic Safety Update Report (PSUR)
Product Testing

CE Medical can provide pre-compliance testing and guide your company with the appropriate testing.

  • EMC, Low Voltage (LV) Radio Equipment (RED), Medical, and other standards
  • Software Testing
  • Biocompatibility
  • Sterility
Clinical Evaluations

A clinical evaluation is required for medical devices of all risk classes. A Clinical Evaluation Report (CER) documents the conclusions to verify the safety, clinical performance and/or effectiveness of the medical device when used according to the manufacturer’s intended use. CE Medical can guide your company with the CER (plan, analysis and report). 

  • Literature review
  • Analysis and assessment of a literature search
  • We review existing Clinical Evaluation Report (CER) and assess whether there is sufficient clinical data (both quantitatively and qualitatively)
  • Preparation of the CER
Authorised Representative (EC REP) and UK Responsible Person (UKRP)

For manufacturers of medical devices who are based outside of the EU/UK, appointing an Authorised Representative (EC REP) in Europe or a UK Responsible Person (UKRP) in the UK is mandatory. An EC REP/UKRP is a legal party based within the European Union/UK that acts as a liaison between a manufacturer outside of the EU/UK and competent national authorities within the EU/UK. CE Medical can act as an EC REP/UKRP on behalf of your organisation to ensure that the devices being sold on the EU/UK market comply with the product compliance legislations. This concerns devices that are sold either directly, via e-commerce (online), or through a fulfilment service provider. The EC REP/UKRP will register the medical devices with the competent authorities. 

  • Registration in EUDAMED
  • Registration Notis/MHRA
  • Verify the EU/UKCA Declaration of Conformity and the technical documentation
  • Keep technical documentation + EU/UKCA Declaration of Conformity at the disposal of all competent authorities
  • Provide all necessary information and documentation to said competent authorities at their request
  • Provide samples from, or access to, a device upon request of a competent authority
  • Cooperate with the competent authorities in the implementation of preventive or corrective actions
  • Immediate notification of the manufacturer in the event of complaints and reports
Notified Bodies (NoBo)

Medical devices should conform to the requirements stated in the applicable regulations. For higher risk medical devices, the technical documentation must be reviewed by a Notified Body (NoBo). CE Medical can guide this process, and submit the documentation to the Notified Body and ensure that the file is complete for the certification. 

  • Search and selection of NoBo
  • Request quotations from NoBo
  • Guidance with application process with a NoBo
  • Supervising conformity process with NoBo
EUDAMED + UDI

CE Medical can assist with registering in EUDAMED and with 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
Training

CE Medical 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 onto the EU Market.

  • Quality Management Systems
  • Software IEC 62304
  • Technical documentation
  • Medical devices development
Information Supply

We notify you if there are regulatory changes pertaining to your product

Risk Assessment

We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.

  • Machine / Electronics / Toys / Medical / PPE / GPS
  • EN-ISO 12100
  • Safexpert Risk Assessment software (TÜV-certified)
  • Review of existing Risk Assessment
  • Templates
Authorised Representative

We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.

  • EU/UK market access
  • Verification of CE/UKCA
  • Marking
  • Contact point for authorities
  • Technical File
  • Bypass importers
  • Registration
Technical File

Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.

  • Declaration of Conformity
  • User Information (manual/labelling/packaging)
  • Risk Assessment
  • Technical schemes and drawings
  • Templates
Engineering Review

We review your designs and assist you through the prototype phase to ensure critical safety standards are met.

  • Design Review
  • Co-engineering
  • Consultancy
  • Risk Assessment
Testing and Inspection

Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.

  • EMC, Low Voltage, Radio, Medical, Toys, and PPE
  • On-site or digital inspections
  • Notified Bodies
  • Accredited testing laboratories
Route to compliance

We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.

  • Determining product legislation
  • Set up test procedure (in-house/accredited testing)
  • Strategy on Global Market Access
  • Technical File Checklist
Training

We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.

  • Product Compliance
  • CE Marking
  • Machine / Robotics Safety
  • UL/CSA
  • Safexpert
User Information Review

Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.

  • Checklists
  • Product labelling
  • Templates
  • Drafting Manuals
  • Machine plate
Technical File

We ensure the availability of the technical file in case of requests from authorities

Expert Consulting

With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.

  • Product Compliance
  • Authority letter (NVWA, NoBo, ILT and BPT)
  • Authorised Representative
  • Product Testing
  • Seller/buyer problem resolution on CE marking
  • Advise on Product Legislation
  • User Information
  • Route to compliance
  • Engineering Review
  • Training
  • Risk Assessment
CE/UKCA Marking

Trust us as your partner to verify the compliance of your products

Authorised Representative

We register as your official point of contact for market surveillance authorities

EU/UK Market Access

You gain access to the EU/UK market, no matter where your business is located

Legal point of contact

We represent you on your behalf for all legal issues pertaining to your product

Compliance

Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.

  • Consultancy
  • Route to compliance
  • Testing
  • On-site inspections
  • Design Review
  • Technical File Review
  • Risk Assessment
  • Training