CE Certification for Medical Devices: Key Elements You Must Know

From band-aid to hearing-aid, innumerable objects are classified as medical devices. Each medical device (MD) has a specific set of standards to comply to. This comprehensive guide is aimed at analyzing the basics and responsibilities of CE marking your medical device. 

How are MDs classified?

The classification of a medical device is the most essential part of the certification as this forms the basis for the path to take to conformity. A medical device is a very broad concept, e.g. a band-aid is a medical device as well as a pacemaker. These devices all fall under the Medical Device Regulation.

In order to distinguish these devices, they are classified in different risk classes. The risk classes are divided into Class I, IIa, IIb and III. A device in Class I is a device with low risk, and a device of Class III has a high risk. The classification is very dependable on the characteristics of the medical device.

Annex IX classifies MDs on the following factors:

  • The period for which the MD is in continuous use.
  • Whether the MD is surgically invasive or not
  • Whether the MD is an implant or an active device.
  • Whether the device contains a clearly defined medicinal substance or not.

MDs are classified into one of the following:

  • Class I (low-medium risk MDs)
  • Class IIaIIb and III (medium to high risk MDs)
  • Class III (highest risk MDs)

Higher the classification, greater the level of assessment required for the product.


What is the basis of classification of MDs?

The Intended Purpose for Use, alongside other factors, determines the class of the medical device. In case two MDs have identical technical characteristics, their class can be different based solely on the Intended Purpose of Use.

The scope of the Intended Purpose of Use includes:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • The investigation, replacement or modification of the anatomy or of a physiological process,
  • Controlling conception


At
Certified Experts, we clearly define the Intended Purpose such that it is classified correctly at the start of the CE marking process. With 25 years of experience with a variety of Medical Devices, we can classify your specialized Medical Device, earn the CE certification and maintain the required long-term protocol.


What Directives / Regulations do the MDs need to meet?

There are frequent updates to the Directives and the MD may be subject to additional regulation if needed. MDs usually fall under one of the Medical Directives:

  • Medical Devices Directive (93/42/EEC)
  • In Vitro Diagnostic Devices Directive (98/79/EC)
  • Active Implantable Medical Devices Directive (90/385/EEC)

Though very important the new Medical Device Regulation has been put into working since 25th of May 2017, and the transition period is almost expired on May 26th 2020:

The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). We also deal with MDs that required compliance with these additional directives as well:

Class II and Class III MDs may require the EN/ISO 13485 Quality System certification to complete the CE process.


How to obtain the Declaration of Conformity (DoC) 

We have developed our five-step approach in order to certify your medical device.

STEP 1. Identify EU requirements for your product

STEP 2. Assess the level of conformity and testing

STEP 3. Assistance and review of the technical documentation

STEP 4. CE Mark can be affixed and declaration of conformity is issued

STEP 5. Product is certified and can be traded in the EU


What is the European CE Technical File or Design Dossier Compilation?

All MDs require the CE Technical file for CE marking. For Class II and Class III MDs, it is obligatory for the manufacturer/ importer to appoint a Notified Body to audit this file. As example, it includes the following information about the MD:

  • Design
  • Function
  • Composition
  • Clinical Evaluation Report


What is the Clinical Evaluation Report (CER)?

The CER is an essential part of the CE Technical File. It provides strong clinical evidence that the MD achieves its Intended Purpose without posing any risk to patient lives. It is based on clinical data from the following sources:

  • Existing literature
  • Clinical experience
  • Clinical trials
  • Any combination of the above three.

Treated as a stand-alone document, it needs regular updates based on:

  • Ongoing clinical evaluations
  • Manufacturer’s/ importer’s post-market surveillance
  • Manufacturer’s/ importer’s vigilance operations


Who is the European Authorized Representative (AR)?

An importer or manufacturer with no presence in Europe is obligated to appoint an Authorized Representative, or AR, with a registered business in the EEA area. This is obligatory for MDs of all classes. The responsibilities of the AR include:

  • Coordinating with the regulatory authority
  • Keeping the updated Technical Documentation available for authorities at least five years after manufacture of the product
  • Registering, updating, and/or notifying class I, and IVD, Medical Devices with the EEA Competent Authorities
  • Assisting in Incident Reporting and Product Recalls
  • Issuing of Advisory Notices as required
  • Certification Experts as your CE partner

At Certification Experts, we identify how often these updates are necessary and develop a strong protocol to keep all literature in accordance to evolving EU requirements. This is an ongoing active process.

  • Certification Experts as your CE partner

At Certification Experts, we identify how often these updates are necessary and develop a strong protocol to keep all literature in accordance to evolving EU requirements. This is an ongoing active process.