Medical Devices

CE Marking services according to the Medical Device Regulation (MDR) 2017/745

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 market.

Medical-Devices-CE-Marking-services-Medical-Device-Regulation-MDR-2017745

CE mark medical devices

The CE mark 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 medical devices CE marking and 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, which 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 will take the burden of obtaining CE medical device certification off your team.

Who We Serve

Medical Devices

Trust our Medical Team to handle the CE marking process for you

CE Marking for Medical Devices: from MDD to MDR

What was previously known as the Medical Device Directive 93/42/EEC (MDD) has been replaced by Medical Device Regulation 2017/745 (MDR).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, a European database

Why is a CE approval needed 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. The CE mark definition medical device 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

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 and implement a Quality Management System (QMS). Furthermore, when applicable, it is required to a involve a Notified Body (NoBo) for certification.

Full-service MDR compliance

What classes are there?

Classifying your product is an essential part of the CE certification for medical devices. As indicated, based on the intended use and medical claims, it is determined whether the classification rules apply to your device. If the product is recognised as a medical device, it is classified, after which the appropriate conformity assessment procedure is identified. Because of the transition from MDD to MDR, it is also possible that your device currently falls within a different class than it might have previously. The following table provides an overview of all classes.

Classification of devices

ClassExampleNotified Body Involvement
Class I – Low risk medical devicesSpectacles, sports tapeNone
Class Is – Sterile low risk medical devicesSterile single-use syringesFocuses on aspects related to establishing, securing, and maintaining sterile conditions
Class Im – Low risk medical devices for measuringClinical thermometers, droppers, non-evasive blood pressure measuring deviceEnsures compliance with metrological requirement
Class Ir – Reusable low risk non-invasive surgical medical devices

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

Assesses aspects related to device reuse, including cleaning, disinfection, sterilization, maintenance, functional testing, and the associated instructions for use
Class IIa – Medium risk medical devicesPelvic floor muscle trainers, most Medical Device Software (MDSW)Certifying the technical file and the quality management system and issuing the EC Certificate
Class IIb – Medium to high risk medical devices
Blood bags, urethral stents, dental implants, penile implantsCertifying the technical file and the quality management system and issuing the EC Certificate
Class III – High risk medical devices Prosthetic heart valves, cardiovascular sutures, breast implants, breast tissue expandersCertifying the technical file and the quality management system and issuing the EC Certificate

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

How can I start the CE marking process for 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 labeling 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 replaced by the MDR, obtaining CE mark medical devices 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.

Because of Brexit, medical devices that are currently being sold on the UK market may need to be UKCA marked, instead of CE marked. Our experts can help you obtain a UKCA mark. 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 Healt Care products Regulatory Agency). It is also possible to let us obtain a CE marking for electrical equipment for your company.

Portfolio

Check out our services

Discover how our experts can assist you in achieving compliance for your medical devices.

Frequently asked questions

All the answers you might need!

Testimonials

Discover our Success Stories

Van Heek Medical

Wilma Peereboom Quality Coordinator
The cooperation with Certification Experts is satisfactory. They are decisive from the start and one of their main strengths is their excellent problem-solving skills.

New Compliance

Carolina Koster Operations Manager
Your expert conducted an internal audit for ISO 13485 at our company. The pre-audit communication was clear and brought valuable expertise. Despite some challenges, your expert was understanding and fostered a relaxed atmosphere. The audit was thorough and effectively pinpointed our areas for improvement. We are grateful and will be working on the feedback.

Alfa Wassermann

Kurt Spiegel Vice President of Engineering
Certification Experts has been our partner for over 10 years and the relationship is outstanding. They’ve completed CE Marking, UKCA Marking, and act as our Authorized Representative. The face-to-face meetings are really important and save us a lot of time!

Full-service MDR compliance

Leave it to us