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:
The following products will also be considered medical devices:
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.
Regulation (EU) 2017/745 on medical devices establishes the requirements for all medical devices. These may vary according to their classification:
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:
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.
Our CE Marking consulting projects are structured in the following phases:
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.
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…