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Trusted compliance services for your medical devices

ready to access any global market

From expert consulting to full-service solutions, our specialist medical team can handle all your compliance requirements

Safe, reliable MDR certification

Certification Experts has over 25 years’ experience handling classification and certification of medical devices according to the MDD and Medical Devices Regulation 2017/745 (MDR).

From start to finish

Obtaining CE Mark certification can be a complex and lengthy process. As your full-service compliance partner we can take this burden off your team, freeing up more of your time

Specialist consulting and insights

Alongside our start-to-finish compliance service for medical devices, we also offer expert consulting and advice on classification and other regulatory issues.

Let our dedicated
medical team handle all
your compliance needs

An all-in-one compliance partner you can rely on

Together with notified bodies we handle the entire compliance process for you, freeing up your time so you can focus your expertise where it really matters

Get specialist MDR compliance advice

Unsure if your product classifies as a medical device or if you need a quality management system like ISO 13485? Our specialists can advise you on a range of medical compliance issues

Comply with all legal regulations in your markets

Our dedicated team handles gap analysis with the MDD-MDR, performs clinical trials and reviews according to all relevant EN/ISO standards, and assists with legal registration

A simpler path to your EU declaration of conformity

Compiling the right paperwork can be daunting and time-consuming for producers of medical devices. Our experts help assemble and verify your technical file so all paperwork, labelling and manuals are correct

Authorised Representation

If you’re based outside the EU orUK and want to sell your medical devices there, we can act as your AR (Authorised Representative), verifying your technical documents & products and allowing you to enter these markets

INSIGHT

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

INSIGHT

What is a Declaration of Conformity?

INSIGHT

Soon..

Open Insight

Your start-to-finish
product compliance partner

Whether you’re looking for expert consulting on a compliance issue or need a full-service certification partner, we’ve got you covered.

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

Get certified in the next 3 - 6 weeks with our proven process

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

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
Previous
Next

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