Switching from IVDD to IVDR

Switching from IVDD to IVDR

Switching from IVDD to IVDR

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.

Transition from IVDD to 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:

  • Higher quality and safety standards are being set for in vitro diagnostic medical devices
  • Clearer definitions and scopes are being introduced
  • Increased traceability of development and production processes throughout the supply chain
  • European legislation is partially harmonized with the laws of other countries, which facilitates global trade.

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.

Certification under IVDD and IVDR
Certification under IVDD and IVDR

The most significant differences between IVDD and IVDR

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:

Definitions and scope

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).

New classification

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.

Classification under IVDD and IVDR
Classification under IVDD and IVDR

Product Lifecycle Management

IVDR 2017/746 requires the manufacturer to take a more rigorous approach to product lifecycle management, including:

  • creation of more strict internal standards in the field of quality management
  • additional requirements regarding the collection and analysis of clinical data
  • additional requirements regarding post-market surveillance
  • additional requirements regarding the identification and traceability of the movement of products for in vitro diagnostics within the EU.

Supply Chain Control

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.

Person Responsible for Regulatory Compliance (PRRC)

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.

Регистрация в EUDAMED

Need EC REP or PRRC for the EU?

Contact us right now:

+49 176 67510274

info@mdrc-consulting.com

Transition from IVDD to IVDR: what's to be done

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.

We are here to help you place your medical devices on your strategic markets.

+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.

Transition from IVDD to 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:

  • Higher quality and safety standards are being set for in vitro diagnostic medical devices
  • Clearer definitions and scopes are being introduced
  • Increased traceability of development and production processes throughout the supply chain
  • European legislation is partially harmonized with the laws of other countries, which facilitates global trade.
Регистрация в EUDAMED

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.

Certification under IVDD and IVDR
Certification under IVDD and IVDR

The most significant differences between IVDD and IVDR

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:

Definitions and scope

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).

New classification

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.

Classification under IVDD and IVDR
Classification under IVDD and IVDR

Product Lifecycle Management

IVDR 2017/746 requires the manufacturer to take a more rigorous approach to product lifecycle management, including:

  • creation of more strict internal standards in the field of quality management
  • additional requirements regarding the collection and analysis of clinical data
  • additional requirements regarding post-market surveillance
  • additional requirements regarding the identification and traceability of the movement of products for in vitro diagnostics within the EU.

Supply Chain Control

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.

Person Responsible for Regulatory Compliance (PRRC)

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.

Transition from IVDD to IVDR: what's to be done

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.


We are here to help you place your medical devices on your strategic markets.

+49 176 67510274

info@mdrc-consulting.com


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