Medical Device Regulation MDR (EU) 2017/745 and In Vitro Diagnostic Medical Device Regulation IVDR (EU) 2017/746 state that every medical device manufacturer whose products are on the EU market is required to have at its disposal a Person Responsible for the Regulatory Compliance (PRRC).
The European Union Medical Device Regulation EC 2017/745 (MDR) is the main medical devices regulation (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 the new MDR requirements.
MDRC helps medical devices manufacturers achieve MDR compliance and open your way to the EU medical devices market.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (Directive 98/79/EC). The Regulation was published in May 2017. Originally approved medical devices will have a transition time until 26 May 2022 to meet the new IVDR requirements. As a European regulation, Regulation EC 2017/746 will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
MDRC helps medical devices manufacturers achieve IVDR compliance and open your way to the EU medical devices market.
Regulation EC 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products amending Directive 2001/83/EC and Regulation EC 726/2004 is the basis of the regulatory framework regulating gene, cell and tissue medicinal products on the European market. The Regulation is directly applicable in the Member States of the European Union and requires no incorporation into national law.
MDRC helps manufacturers of gene, cell or tissue medicinal products achieve EC 1394/2007 compliance and open your way to the EU advanced therapy products market.
Most Class I and some Class II devices are exempt from 510(k) requirements and subject to certain limitations. A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device. Devices which may be exempt from 510(k) requirements are preamendments devices and Class I and Class II devices specifically exempted by the FDA.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
MDRC helps medical devices manufacturers achieve FDA compliance and open your way to the US medical devices market.
ISO 13485 Medical devices quality management systems is an International Organization for Standardization (ISO) standard. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996). There has been several editions of ISO 13495. The current ISO 13485 edition was published on 1 March 2016. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Regulations EC 2017/745 and EC 2017/746 must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according to ISO 13485.
MDRC will help you create an ISO 13485 compliant Quality Management System.
FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a document that outlines Current Good Manufacturing Practice (CGMP) regulations. This document governs manufactures to help ensure their products consistently meet applicable requirements and specifications. FDA 21 CFR Part 820 is the quality system approved by the FDA. These requirements are to ensure that medical devices are both safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance. The FDA has determined that certain types of medical devices are exempt from these regulations. You can find a list of published in the Federal Register and codified in 21 CFR 862 to 892.
MDRC will help you create a 21 CFR 820 compliant Quality Management System.
Regulatory requirements of the Latin American countries are harmonized under the South American trade bloc Mercosur (including Argentina, Brazil, Paraguay, Uruguay and associated countries) regulatory framework. Mexico is not a Mercosur country and its regulatory system differs from the Mercosur regulations. Generally, in LATAM countries regulatory decisions are often made on case by case basis.
We help medical devices manufacturers pass through the regulatory barriers in Latin America.
The European Union Medical Device Regulation EC 2017/745 (MDR) is the main medical devices regulation (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 the new MDR requirements.
MDRC helps medical devices manufacturers achieve MDR compliance and open your way to the EU medical devices market.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (Directive 98/79/EC). The Regulation was published in May 2017. Originally approved medical devices will have a transition time until 26 May 2022 to meet the new IVDR requirements. As a European regulation, Regulation EC 2017/746 will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
MDRC helps medical devices manufacturers achieve IVDR compliance and open your way to the EU medical devices market.
Regulation EC 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products amending Directive 2001/83/EC and Regulation EC 726/2004 is the basis of the regulatory framework regulating gene, cell and tissue medicinal products on the European market. The Regulation is directly applicable in the Member States of the European Union and requires no incorporation into national law.
MDRC helps manufacturers of gene, cell or tissue medicinal products achieve EC 1394/2007 compliance and open your way to the EU advanced therapy products market.
Most Class I and some Class II devices are exempt from 510(k) requirements and subject to certain limitations. A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device. Devices which may be exempt from 510(k) requirements are preamendments devices and Class I and Class II devices specifically exempted by the FDA.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalence claims.
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. PMA is the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use.
MDRC helps medical devices manufacturers achieve FDA compliance and open your way to the US medical devices market.
ISO 13485 Medical devices quality management systems is an International Organization for Standardization (ISO) standard. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 (1993 and 1996) and EN 46002 (1996). There has been several editions of ISO 13495. The current ISO 13485 edition was published on 1 March 2016. Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to European Union Regulations EC 2017/745 and EC 2017/746 must be assessed before sale is permitted. One of the major requirements to prove conformity is the implementation of the Quality Management System according to ISO 13485.
MDRC will help you create an ISO 13485 compliant Quality Management System.
FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a document that outlines Current Good Manufacturing Practice (CGMP) regulations. This document governs manufactures to help ensure their products consistently meet applicable requirements and specifications. FDA 21 CFR Part 820 is the quality system approved by the FDA. These requirements are to ensure that medical devices are both safe and effective. Medical device manufacturers undergo FDA inspections to ensure FDA 21 CFR 820 compliance. The FDA has determined that certain types of medical devices are exempt from these regulations. You can find a list of published in the Federal Register and codified in 21 CFR 862 to 892.
MDRC will help you create a 21 CFR 820 compliant Quality Management System.
Regulatory requirements of the Latin American countries are harmonized under the South American trade bloc Mercosur (including Argentina, Brazil, Paraguay, Uruguay and associated countries) regulatory framework. Mexico is not a Mercosur country and its regulatory system differs from the Mercosur regulations. Generally, in LATAM countries regulatory decisions are often made on case by case basis.
MDRC helps manufacturers of medical devices secure regulatory approvals and place their products on the European market.
Pass through all regulatory barriers together with MDRC and place you product on the US market.
MDRC is your guide to the medical devices markets of Latin America.
We will help you achieve compliance with Russian regulations and put your medical devices on the Russian market.
MDRC helps manufacturers of medical devices secure regulatory approvals and place their products on the European market.
Pass through all regulatory barriers together with MDRC and place you product on the US market.
MDRC is your guide to the medical devices markets of Latin America.
We will help you achieve compliance with Russian regulations and put your medical devices on the Russian market.
Both Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Device Regulation (EU IVDR 2017/746) state that where a non-EU manufacturer places a medical device on the European market, he shall designate an Authorized Representative in the European Union (EC REP).
We're redy to help you. Contact us whether you have a question about our solutions or need help with regulatory issues
PRRC: Person responsible for regulatory compliance
CE-certificate and EC-certificate for medical devices: what are these certificates and who needs them
Basic UDI-DI: what is it, where does it come from, why do you need it?
Switching from IVDD to IVDR
UDI: Unique Device Identification
EUDAMED registration: requirement under MDR 2017/745 and IVDR 2017/746
GSPR: General Safety and Performance Requirements for medical devices in the EU
PRRC: qualification and location
MDR technical documentation checklist
