General medical devices, medical equipment

General medical devices, medical equipment

Regulatory authorities in most countries consider as medical devices: instruments, apparatus, appliances, software, implants, reagents, materials or other articles intended by the manufacturer to be used, alone or in combination, for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability of human beings and which does not achieve its principal intended action by pharmacological, immunological or metabolic means (but which may be assisted in its function by such means).

Regulatory authorities in most countries consider as medical devices: instruments, apparatus, appliances, software, implants, reagents, materials or other articles intended by the manufacturer to be used, alone or in combination, for diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability of human beings and which does not achieve its principal intended action by pharmacological, immunological or metabolic means (but which may be assisted in its function by such means).

The European Union Medical Device Regulation EC 2017/745 (MDR) is the main medical devices regulation (including active implantable devices but with the exception of in vitro diagnostic products) of the European Union. Regulation EC 2017/745 repeals the existing directives on medical devices: Medical Devices Directive 93/42/EEC (general medical devices) and Directive 90/385/EEC (active implantable medical devices). The regulation was published on 5 May 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time until 26 May 2021 to meet provisions of the new MDR.

In the USA all medical devices including in vitro diagnostic devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). All medical devices are subject to a unified classification (classes I, II, III) and regulatory processes: 510(k) exemption, 510(k) и Premarket Approval.

In LATAM countries medical device markets are regulated by national standards of separate countries. However, those standards are similar and largely harmonized in Mercosur countries (Argentina; Brazil; Paraguay; Uruguay and associated countries). Mexico which is not a Mercosur member differs from other Latin American countries in terms of the medical device regulations.

The European Union Medical Device Regulation EC 2017/745 (MDR) is the main medical devices regulation (including active implantable devices but with the exception of in vitro diagnostic products) of the European Union. Regulation EC 2017/745 repeals the existing directives on medical devices: Medical Devices Directive 93/42/EEC (general medical devices) and Directive 90/385/EEC (active implantable medical devices). The regulation was published on 5 May 2017 and came into force on 25 May 2017. Originally approved medical devices will have a transition time until 26 May 2021 to meet provisions of the new MDR.

In the USA all medical devices including in vitro diagnostic devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). All medical devices are subject to a unified classification (classes I, II, III) and regulatory processes: 510(k) exemption, 510(k) и Premarket Approval.

In LATAM countries medical device markets are regulated by national standards of separate countries. However, those standards are similar and largely harmonized in Mercosur countries (Argentina; Brazil; Paraguay; Uruguay and associated countries). Mexico which is not a Mercosur member differs from other Latin American countries in terms of the medical device regulations.

MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them. Regardless of your device's class and type, from disinfectants, sanitizers and face masks to complex medical equipment, automated systems and medical software.

MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Also, we assess whether your products require additional tests and studies and help organize them. Regardless of your device's class and type, from disinfectants, sanitizers and face masks to complex medical equipment, automated systems and medical software.

TYPES AND CLASSES OF MEDICAL DEVICES IN DIFFERENT COUNTRIES

TYPES AND CLASSES OF MEDICAL DEVICES IN DIFFERENT COUNTRIES

What regulatory approval procedures are needed to place a medical device on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.

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What regulatory approval procedures are needed to place a medical device on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.

We will put your medical devices on your strategic markets in a timely and cost-efficient manner. MDRC are experts on all types and classes of medical devices. Entrust your regulatory affairs to the professionals.

We will put your medical devices on your strategic markets in a timely and cost-efficient manner. MDRC are experts on all types and classes of medical devices. Entrust your regulatory affairs to the professionals.

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