CE marking of medical devices

Regulation (EU) 2017/745 on medical devices is a further step towards the standardisation of these devices throughout Europe. Although the process may seem complicated and the CE Marking regulations for medical devices broad and deep, we understand it as an opportunity in an increasingly globalised market.

A medical device is understood to be an instrument, tool, equipment, computer program, implant, reagent, material or other article intended by the manufacturer to be used in people, separately or in combination, with any of the following specific medical purposes:

  • Diagnosis, prevention, monitoring, prognosis, treatment or alleviation of diseases,
  • Diagnosis, prevention, monitoring, prediction, cure or mitigation of injuries or disabilities,
  • The investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
  • Obtaining information by in vitro examination of samples from the human body (including organ, blood and tissue donations) that do not exert their intended main action inside or on the surface of the human body by pharmacological, immunological or metabolic mechanisms, but to whose function such mechanisms may contribute.

The following products will also be considered medical devices:

  • Control or support for conception; support or sustaining of life, etc.
  • Products specifically intended for cleaning, disinfection or sterilization of medical devices and their accessories.

It is crucial to bear in mind that the “accessories” of medical devices, according to community regulations, are also understood as “medical devices” and, like other devices, must comply with the established laws.

Requirements for medical devices

Regulation (EU) 2017/745 on medical devices establishes the requirements for all medical devices. These may vary according to their classification:

  • Marketing and commissioning of products, obligations of the different agents involved, reprocessing, CE marking and free movement.
  • Identification and traceability of products, registration of products and economic agents. Safety and clinical performance. European database on medical devices.
  • Classification and conformity assessment.
  • Evaluation and clinical investigations.
  • Post-marketing monitoring, surveillance and market control.
Classification of medical devices

The products are classified in classes I, IIa, IIb and III, taking into account the intended purpose of the goods and their inherent risks. Regulation (EU) 2017/745 increases the scope of the law, including some more products:

  • Products for cleaning, sterilising or disinfecting medical devices.
  • Non-medical products included in Annex XVI.
  • Products that incorporate or consist of a nanomaterial.
  • Active implantables and their accessories that have been included in class III.

Standalone software (like apps) has their own classification rule.

Class I products do not require the intervention of notified bodies except those sterile, with a measurement function or reprocessed.

E.G. CE marking of Class I: Products for the collection of body fluids (urine bags), products to immobilize parts of the body or to apply compression (bandages, elastic stockings), products for patient support (walkers, canes), and others (glasses, enemas, examination lamps).

E.G. CE marking of Class I Sterile Medical Devices: Exam gloves, syringes, gravity infusion sets, gauze to protect wounds or to absorb exudates, reusable surgical instruments.

E.G. CE marking of Class I Medical Device with measuring function: syringes, non-electronic thermometers, tonometers.

E.G. CE marking of Class IIa Medical Devices: cardiopulmonary bypass circuits, urological probes, surgical drains, needles, cannulas, surgical gloves, contact lenses, hearing aids, muscle stimulators: TENS, sphygmomanometers, diagnostic equipment, physiotherapy equipment.

E.G. CE marking of Class IIb Medical Devices: intraocular lenses, tissue filler implants, nonabsorbable surgical sutures, wound dressings that heal by secondary intention, blood bags, hemodialyzers, insulin pens, external defibrillators, diagnostic X-ray equipment, surgical lasers, radiation therapy equipment, intensive care monitoring systems, anaesthesia machines, condoms.

E.G. CE marking of Class III Medical Devices: heart valves, hip replacement, breast prosthesis, vascular endoprosthesis: stents, cardiovascular catheters, absorbable sutures, biological internal tissue adhesives, antibiotic endodontic materials, antimicrobial agent dressings, heparin-coated catheters, condoms with spermicide, bovine vascular patches, collagen dressings.

We provide solutions

Our CE Marking consulting projects are structured in the following phases:

  1. – Identify applicable directives,
  2. – Verify requirements according to Regulation (EU) 2017/745 and standards,
  3. – Identify if the product or device needs a notified body (according to the classification),
  4. – Establishment of a test plan on the product and verify its conformity,
  5. – Establish technical documentation (technical files)
  6. – Evaluation by the notified body, identification of the products with the “CE” marking and issuance of the Declaration of Conformity (DoC).

Our function as a specialised consulting company is the analysis of current regulations to identify the requirements and demands that the client wants to prove.

The organisation must establish a production control system that meets the requirements of UNE-EN ISO 13485. Like all management systems, it has to be based on guidelines and written process sheets.

In a CE Marking project, the evaluation and clinical investigations required by the device are essential. If it is a highly proven product, it must be adequately justified.

Another vital phase of a project of these characteristics is the preparation of technical files with which all aspects of the product must be accredited: description and specifications, information, safety and performance requirements, design and manufacture, benefits and risks, product verification and validation.

Our mission is to make the whole project for CE Marking for sanitary devices easy for the company, always bearing in mind that simplicity can be closely linked to brilliant, in-depth and experienced work.

This solution is aimed at
  • Manufacturers of any medical device (regardless of its classification according to Regulation (EU) 2017/745)
  • Health-related service providers
  • Manufacturers of raw materials and accessories for medical devices
What our customers get

CE marking according to Regulation (EU) 2017/745. Accredited notified bodies: Spanish Agency of Medicines and Medical Devices (AEMPS by its Spanish acronym), BSI, SGS, Dekra, Tüv Nord, Tüv Sud, DNV, Bureau Veritas, DQS, Lloyds Register…

Satisfied customers

CE Marking medical devices projects must be complemented with ISO 13485 projects. Furthermore, they can be easily combined with ISO 9001, ISO 14001 and ISO 45001 management systems.
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