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Transitional period: can in vitro Diagnostic Medical Devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

The European Parliament, by publishing the EU 2022/112 Regulatory, modified the transitional periods, initially foreseen by IVDR art. 110, as following: Certificates issued by Notified Bodies in conformity with IVDD directive before 25th May 2017 are still valid until the expiry date indicated on the certificate, except for certificates issued in accordance with directive Annex [...]

2020-08-20T12:32:42+02:00August 20th, 2020|FAQ, IVDR|

What is the “sell off” provision?

The goal of the “Sell Off” provision (IVDR art. 110 para 4) is to reduce the amount of time in which IVDD-compliant devices, already placed on the market, can be provided by (i.e.) Distributors. According to the new transitory provisions, IVD Devices lawfully placed on the market under the IVDD directive before 26th May 2022, [...]

2020-08-20T12:23:43+02:00August 20th, 2020|FAQ, IVDR|

Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

In most cases, Class A devices can be self-certified, unless they are sold sterile, while for Class B, C and D devices it shall be required a conformity evaluation by a Notified Body designated according to the IVDR (EU) 2017/746. It is important to underline that the 90% of IVDs, for which the “self-certification” modality [...]

2020-08-20T12:13:53+02:00August 20th, 2020|FAQ, IVDR|

What are the main changes provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

Manufacturers of in vitro diagnostic Medical Devices must face important news provided for in the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746, for example: Expansion of product scope. The scope of the IVDs is extended to include devices manufactured for use within a single healthcare institution among high-risk devices. For example, diagnostic [...]

2020-08-20T12:03:44+02:00August 20th, 2020|FAQ, IVDR, IVDR|

How does the Regulation on in Vitro Diagnostic Medical Devices (IVDR) affect the Quality Management System?

When the transitional period will end, all the IVDs to market in the European Union will have to satisfy the requirements of the Regulation on in Vitro Diagnostic Medical Devices (IVDR). In order to obtain the EC IVDR, Manufacturers and Economic Operators must have a Quality Management System. Discover the strategic-regulatory consultancy services Thema Are [...]

2020-08-20T11:51:58+02:00August 20th, 2020|FAQ, IVDR|

When do Manufacturers of in vitro diagnostic Medical Devices have to conform to the IVDR (EU) 2017/746?

In Vitro Diagnostic Medical Devices Manufacturer, according to risk classes, have the following transition periods available for the application of IVDR (EU) 2017/746 Regulation: Until 26th May 2022 for class A non-sterile IVD Devices and for in Vitro Diagnostic Medical Devices CE-marked which do not require the involvement of a Notified BodyUntil 26th May 2025 [...]

2020-08-20T11:39:05+02:00August 20th, 2020|FAQ, IVDR|

What is the in vitro diagnostic Medical Devices regulation IVDR (EU) 2017/746? When does it apply?

The in Vitro Diagnostic Medical Devices Regulation(EU) 2017/746 IVDR rules the in Vitro Diagnostic Medical Devices marketing, provision, and commissioning on the European market. IVDR was published on 5th May 2017 and became effective on 26th May 2017, replacing the EU Directive 98/79/EC on in Vitro Diagnostic Medical Devices. The IVDR (EU) 2017/746 Regulation full [...]

2020-08-20T11:28:45+02:00August 20th, 2020|FAQ, IVDR|
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