Examples of implantable devices include various products from dental filling materials to artificial joints, vascular stents, VP and VA shunts, artificial pacemakers etc. Some drug delivery systems (e.g. insulin pumps) are considered as implantable devices. Some aesthetic medicine devices (e.g. threads for thread lifts or breast implants etc.) are viewed by most regulatory authorities as medical devices. A special category of implantables are active implantable devices.
Examples of implantable devices include various products from dental filling materials to artificial joints, vascular stents, VP and VA shunts, artificial pacemakers etc. Some drug delivery systems (e.g. insulin pumps) are considered as implantable devices. Some aesthetic medicine devices (e.g. threads for thread lifts or breast implants etc.) are viewed by most regulatory authorities as medical devices. A special category of implantables are active implantable devices.
In the European Union implantable devices (including active implantable devices) fall under the Regulation EC 2017/745. Earlier active implantable devices were regulated by Directive 90/385/EEC. In 2017 the new regulation came into force. After May 2021 all implantable devices (including active implantables) are ruled by the general EU medical device Regulation EC 2017/745, which covers all medical devices except in vitro diagnostic devices. According to Regulation EC 2017/745 most implantables are class IIb, some of them (e.g. active devices) are class III.
In the USA all medical devices including implantable devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). Implantable medical devices belong to classes II and III and require either 510(k) clearance or Premarket Approval procedures.
In LATAM countries medical device markets - including implantable devices - 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.
In the European Union implantable devices (including active implantable devices) fall under the Regulation EC 2017/745. Earlier active implantable devices were regulated by Directive 90/385/EEC. In 2017 the new regulation came into force. After May 2021 all implantable devices (including active implantables) are ruled by the general EU medical device Regulation EC 2017/745, which covers all medical devices except in vitro diagnostic devices. According to Regulation EC 2017/745 most implantables are class IIb, some of them (e.g. active devices) are class III.
In the USA all medical devices including implantable devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). Implantable medical devices belong to classes II and III and require either 510(k) clearance or Premarket Approval procedures.
In LATAM countries medical device markets - including implantable devices - 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, medical software and active implantable medical devices.
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, medical software and active implantable medical devices.
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.
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.
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