Europe Medical Device Registration – Compliance with European Directives (MDD, AIMD, IVDD) or Regulations (MDR, IVDR)

Europe Medical Device RegistrationThe European Community has formally adopted several Directives (or regulations – see below) that apply to the Europe Medical Devices Registration. This means that any company, interested in selling a product in one of the European Community countries, must comply with the requirements of the applicable Regulation and must mark its product with the CE symbol according to those requirements. Since 26 May 2021 the Medical Device Regulation 2017/745 which entered into force on 25 May 2017 became mandatory and replaced the Medical Device Directive and the Active Implantable Medical Device Directive (those are no longer an option to obtain CE marking). Regarding the In Vitro Diagnostic Regulation 2017/746 the date of entry into force was also 25 May 2017 and it will become mandatory on 26 May 2022.

The requirements of the CE can be divided into two major categories:

  1. Quality system Requirements, with which the manufacturer should comply, regarding the development and the manufacturing of the product.
  2. Safety and reliability requirements the product should meet, which includes items such as biocompatibility, software validation, electrical safety, electromagnetic compatibility (EMC), performance evidence, technical performance evidence, and pre-clinical and clinical evidence.

How to achieve Europe Medical Device Registration and apply CE mark ?

In order to get CE mark, you need to comply with one or more of the following requirements:

  1. Establish and maintain a Medical Quality Management System (QMS)
  2. Test your product in order to demonstrate compliance with applicable standards
  3. Prepare a Technical File / Design Dossier for each family of products that you wish to obtain CE mark for.
  4. Contract a European Authorized Representative.
  5. Contract a Notified Body who will audit your Quality Management System and Technical Files / Design Dossiers.
  6. Register your company and list your product with at least one European Competent Authority.

The actual requirements for your family of products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.

Here are some examples of devices relating to product classification:

  1. Class I: EEG and EMG Electrodes, non-invasive. Scalpels. Dental Drills. Wound Management systems. Hearing Aid Tester.Corrective glasses. Examination gloves. Hospital beds.Scalpels. Stethoscopes for diagnosis. Stomach pumping tubes. Stretchers. Syringes without needles. Wheelchairs.
  2. Class IIa: All patient monitoring equipment, Syringes. Needles, for syringes. Blood oxygen analyzers. Contact lenses. Crowns. Extracorporeal Circulation Devices. Infusion cannula. Muscle stimulators. Sterilizers for medical devices. Nebulizers. Ultrasound diagnostic equipment. External ECGs.
  3. Class IIb: Lasers Devices for application. Internal ECGs. RF Generators. Non-energized implants. Brachytherapy devices. Condoms. Defibrillators, external. Hemodyalizers. Incubators for babies. Infusion pumps. Lenses, intra-ocular. Lithotriptors. Lung ventilators. Anesthesia machines.
  4. Class III: Energized implants All Intracardiac applications. Bone cements, with antibiotic. Catheters, angioplasty balloon. Catheters, with radioisotopes. Collagen implants. Contraceptive intrauterine devices (IUDs). Electrodes, neurocortical. Prosthetic heart valves. Shunts, carotid artery. Sutures, absorbable . Vascular stents. Bioactive implantable devices.

Example of compliance routes for the Europe medical device registration:

Class I:

The only route for a self-certified medical device of Class I is the maintenance of a technical device.
Documentation in accordance with Annexes II and III. In addition, for Class I devices supplied with sterile (Is), with a measuring function (I m) or reusable surgical instruments (Ir), limited QMS must be in place to control production (Annex XI Part A) or to control special characteristics ( e.g. sterility, measurement, reusable characteristics) (Annex IX – Chapter I).
In the case of Class Is, I m, and Ir devices, an NB will be involved to monitor how the QMS manages those specific features in relation to the conformity assessment procedure selected.

  1. Hold a Technical file
  2. Self-Declaration of Conformity according to Annex II and Annex III.
  3. Contract an Authorized Regulatory Representative based in the European Community
  4. Observe provisions of the procedures related to Annex II and III
  5. Apply for CE mark.

Class Is, Im, Ir:

  1. Contract an Authorized Regulatory Representative based in the European Community
  2. Hold a Technical file as per Annex II and III
  3. Comply with Quality Management System requirements (Annex XI part A or Annex IX Chapter I)
  4. Audit by a notified body according to point 3
  5. Apply for CE mark.

Class IIa:

The conformity assessment procedure for a Class IIa device by means of a full QMS review (Annex IX) is identical to that for a Class IIb non-active and non-implantable device. Alternatively, the manufacturer may construct technical documentation in accordance with Annexes II and III and select a conformity assessment route based on production control (Appendix XI).

  1. Hold a Technical file, implement the ISO 13485 standard to demonstrate conformity with requirements of
    1. Annex IX – Chapter I & Section 4 or
    2. Annex II & Annex III and (Annex XI – Section 10 or Annex XI – Section 18)
  2. Contract an Authorized Regulatory Representative based in the European Community
  3. Audit by a notified body according to point 1 above. Apply CE mark.

Class IIb:

Class IIb devices should be considered part of one of the following categories:

  • Class IIb implantable device
  • Class IIb active device intended to remove or administer medicinal substances
  • Class IIb device not included in the categories above

The level of control for Class IIb devices is similar to that for Class III devices, although there is no separate CE certificate issued for the assessment of the technical documentation. In addition, the participation of the expert panel in the review process is not required unless the Class IIb device is active and is intended to remove or administer a medicinal substance. Finally, a review of the technical documentation shall be carried out on a representative sample of the type of device, with the exception of Class IIb implantable devices for which a 100% review is required.

  1. Hold a Technical file, implement the ISO 13485 standard to demonstrate conformity with requirements of
    1. Annex IX – Chapter I & Section 4 or
    2. Annex X and (Annex XI – Part A or Annex XI – Part B)
  2. Contract an Authorized Regulatory Representative based in the European Community
  3. Audit by a notified body according to point 1 above. Apply CE mark.

Class III:

Annex IX, including a full Quality Assurance audit and a full Technical Documentation Review, is a viable option for Class III medical devices. A certificate is issued following the NB QMS audit and a second certificate is issued for each device after a review of the associated technical documentation. In addition, an expert panel is involved in the assessment of Class III implantable devices.
While the standards are voluntary, one way to presume conformity with the GSPR and to comply with the provisions of full quality assurance is to have harmonized EN ISO 13485 certification, which relates to the state of the art and to the expected requirements of the company’s quality management system in the EU.

It should be noted that manufacturers of Class III medical devices also have the option of applying Annex X, Type-Examination, in combination with Annex XI, Part A or Part B, and therefore with a production and control QMS.

  1. Hold a Technical file, implement the ISO 13485 standard to demonstrate conformity with :
    1. Annex XI or
    2. Annex X and (Annex XI – Part A or Annex XI – Part B)
  2. Contract an Authorized Regulatory Representative based in the European Community
  3. Audit by a notified body according to Annex II.
  4. Product Dossier Exam by a notified body according to point 1 above. Apply CE mark.

How to Get CE Mark for IVD Device ?

In order to get CE mark, you need to comply with the same general requirements mentioned earlier for Medical Devices.

The actual requirements for your family of products are subjected to the classification of your devices. This classification is based on the level of risk your device contains.

Here are some examples of devices relating to product classification.

General: Automated Tissue Resistance Measuring System, Automatic Cell Counter, Centrifuges, Chromatograph, Gas blood Analyzer, Haematology Analizar, Ion Blood Analyzer, Osmometer, pH-meter, Vis / UV-Vis Spectrophotometer

Self Diagnostic:Cholesterol Test, Male Fertility Test, Menopause Test, Ovulation Predictor Test, Pregnancy Test, Urine Qualitative Dipstick Bilirubin, Urine Qualitative Dipstick pH, Vaginal Acidity Test

List A: Reagents and reagent products, including related calibrators and control materials, for determining the following blood groups: ABO system, rhesus (C, c, D, E, e) anti-Kell,

List B: Reagents and reagent products, including related calibrators and control materials, for determining irregular anti-erythrocytic antibodies.

How we can help:

Kobridge will assist in preparing and the technical file or Product Dossier to obtain your CE Certification. We can parallel for the implementation of a quality management system in compliance with the ISO 13485 and ISO 14971 in order to achieve Europe medical device registration.

More info:

You can find more information on this page http://ec.europa.eu/health/medical-devices/index_en.htm

If your product falls into such category and you wish to sell in Europe you can contact us for a preliminary discussion.