From May 26, 2022, all manufacturers of IVD products selling their products in Europe must ensure that their products comply with the European Regulation IVDR 2017/746. Below we will discuss what this means in practice, and what actions manufacturers should take to comply with the new requirements of IVDR.
EU Directive IVDD 98/79 had a number of deficiencies that IVDR is supposed to address. In general, from the point of view of European regulatory authorities, the transition from IVDD to IVDR brings about the following positive changes:
At the same time, from the point of view of in vitro medical device companies, the transition from IVDD to IVDR means an additional regulatory burden, which means additional risks and costs. And the main ones are related to the introduction of a new classification of products for in vitro diagnostics and the emergence of the need to involve Notified Bodies in the conformity assessment for those products for which this was not required before.
IVDR should not be viewed simply as an extension of IVDD. The introduction of this regulation implies a conceptually new approach to many aspects of the regulation of in vitro diagnostic medical devices in the European Union. The most significant changes are listed below:
IVDR provides clearer definitions of key concepts and covers a broader range of products than IVDD, including products that use new technologies such as software products or personalized diagnostic products. In addition, IVDD regulates diagnostic services provided via the Internet using diagnostic products located outside the EU (for example, remote genetic testing).
One of the major changes associated with the entry into force of the IVDR was the introduction of a rule-based classification, as opposed to the list-based classification introduced in the IVDD.
According to the old classification, medical devices for in vitro diagnostics were divided into "general" devices and devices related to lists A or B of Annex II of the IVDD. The involvement of a Notified Body and certification required only products belonging to the specified lists (they accounted for about 20% of all products for IVD).
According to the new classification, medical products for in vitro diagnostics are divided into four classes on the basis of risk associated with their use - classes A, B, C and D. The involvement of Notified Bodies is required for all products, except those belonging to class A, i.e. 80% of all products for in vitro diagnostics.
IVDR 2017/746 requires the manufacturer to take a more rigorous approach to product lifecycle management, including:
The new EU regulation places additional responsibilities on economic operators (manufacturers, importers, distributors, authorized representatives) in relation to the control of supply chains. According to IVDR, each participant in the chain is obliged to control the regulatory compliance of the previous links in the chain with which he directly works. Also, IVDR gives Notified Bodies the right to inspect not only the manufacturer, but also his suppliers and subcontractors.
A new requirement is that manufacturers and authorized representatives must have at their disposal a Person Responsible for Regulatory Compliance (PRRC). Such a person must either be on the staff of the company, or (if the company is a small or micro-enterprise) can be outsourced. PRRC is responsible not only for the IVDR compliance of the company for which it works, but also for the regulatory compliance of the entire supply chain.
Need EC REP or PRRC for the EU?
Contact us right now:
+49 176 67510274
info@mdrc-consulting.com
Changes in European IVD legislation call for a number of measures on manufacturer's part. Among them are the revision of the regulatory strategy, the re-classification based on the rules set forth in IVDR, the gap analysis of technical documentation and the quality management system, the search for a Notified Body (if necessary), etc.
Actions aimed at the timely transition to the new legislation allow the manufacturer to avoid losses and timely ensure regulatory compliance with the In Vitro Medical Device Regulation.
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+49 176 67510274
info@mdrc-consulting.com
From May 26, 2022, all manufacturers of IVD products selling their products in Europe must ensure that their products comply with the European Regulation IVDR 2017/746. Below we will discuss what this means in practice, and what actions manufacturers should take to comply with the new requirements of IVDR.
EU Directive IVDD 98/79 had a number of deficiencies that IVDR is supposed to address. In general, from the point of view of European regulatory authorities, the transition from IVDD to IVDR brings about the following positive changes:
Need EC REP or PRRC for the EU?
Contact us right now:
+49 176 67510274
info@mdrc-consulting.com
At the same time, from the point of view of in vitro medical device companies, the transition from IVDD to IVDR means an additional regulatory burden, which means additional risks and costs. And the main ones are related to the introduction of a new classification of products for in vitro diagnostics and the emergence of the need to involve Notified Bodies in the conformity assessment for those products for which this was not required before.
IVDR should not be viewed simply as an extension of IVDD. The introduction of this regulation implies a conceptually new approach to many aspects of the regulation of in vitro diagnostic medical devices in the European Union. The most significant changes are listed below:
IVDR provides clearer definitions of key concepts and covers a broader range of products than IVDD, including products that use new technologies such as software products or personalized diagnostic products. In addition, IVDD regulates diagnostic services provided via the Internet using diagnostic products located outside the EU (for example, remote genetic testing).
One of the major changes associated with the entry into force of the IVDR was the introduction of a rule-based classification, as opposed to the list-based classification introduced in the IVDD.
According to the old classification, medical devices for in vitro diagnostics were divided into "general" devices and devices related to lists A or B of Annex II of the IVDD. The involvement of a Notified Body and certification required only products belonging to the specified lists (they accounted for about 20% of all products for IVD).
According to the new classification, medical products for in vitro diagnostics are divided into four classes on the basis of risk associated with their use - classes A, B, C and D. The involvement of Notified Bodies is required for all products, except those belonging to class A, i.e. 80% of all products for in vitro diagnostics.
IVDR 2017/746 requires the manufacturer to take a more rigorous approach to product lifecycle management, including:
The new EU regulation places additional responsibilities on economic operators (manufacturers, importers, distributors, authorized representatives) in relation to the control of supply chains. According to IVDR, each participant in the chain is obliged to control the regulatory compliance of the previous links in the chain with which he directly works. Also, IVDR gives Notified Bodies the right to inspect not only the manufacturer, but also his suppliers and subcontractors.
A new requirement is that manufacturers and authorized representatives must have at their disposal a Person Responsible for Regulatory Compliance (PRRC). Such a person must either be on the staff of the company, or (if the company is a small or micro-enterprise) can be outsourced. PRRC is responsible not only for the IVDR compliance of the company for which it works, but also for the regulatory compliance of the entire supply chain.
Changes in European IVD legislation call for a number of measures on manufacturer's part. Among them are the revision of the regulatory strategy, the re-classification based on the rules set forth in IVDR, the gap analysis of technical documentation and the quality management system, the search for a Notified Body (if necessary), etc.
Actions aimed at the timely transition to the new legislation allow the manufacturer to avoid losses and timely ensure regulatory compliance with the In Vitro Medical Device Regulation.
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