European Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation (IVDR)
The European Commission has issued a proposal for extending the transitional arrangements for the new In Vitro Diagnostic Medical Devices Regulation (IVDR) to prevent disruption in the supply chain.
Liliana Teles

Liliana Teles

Regulatory Affairs Manager

The unprecedented challenges of the COVID-19 pandemic led the European Commission to issue a proposal for extending the transitional arrangements for the new In Vitro Diagnostic Medical Devices Regulation (IVDR).

After European Parliament’s approval and adoption, the existing transitional period for in vitro diagnostic medical devices covered by notified body certificates issued under Directive 98/79/EC should be extended by 1 year, until 26 May 2025. Additionally, devices for which the conformity assessment procedure pursuant to Directive 98/79/EC did not require the involvement of a notified body and for which the conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body, may benefit from a grace period.

The length of the proposed transition periods depends on the type of device: higher risk devices such as class D and C would have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, would have a transition period until May 2027, as follows:

(a) 26 May 2025 for class D devices;
(b) 26 May 2026 for class C devices;
(c) 26 May 2027 for class B devices;
(d) 26 May 2027 for class A devices placed on the market in sterile condition.

The proposed amendments will not delay the application of the IVDR to CE marked in vitro diagnostic medical devices that do not require the involvement of a notified body (i.e. class A non-sterile devices) and to ‘new’ in vitro diagnostics (i.e. those not covered by a certificate or declaration of conformity issued under Directive 98/79/EC). For these devices, the IVDR is envisaged to apply in full from 26 May 2022.

The proposal does not change any requirements of the IVDR in substance but only changes the transitional provisions to allow the IVDR’s progressive rollout. The date of application remains unchanged, so IVDR vigilance and Post-Market Surveillance (PMS) requirements apply from 26 May 2022 for all devices on the market under IVDD and IVDR.

References:

Proposal for a Regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (14.10.2021)


further
reading

drug_device_combination_1
medical devices

Regulatory Framework of Drug-Device Combination

The advances in technology continue to merge different types of products and the historical lines of separation between medical devices and medicinal products are getting thinner. Products combining medicinal products and medical devices are regulated either by Regulation (EU) 2017/745 (MDR) or by Directive 2001/83/EC.

Read More »
cosmetic products

SCCS Preliminary Opinion on Alpha-Arbutin and Beta-Arbutin

Alpha-arbutin and Beta-arbutin are used in cosmetic with antioxidant, bleaching and skin conditioning functions. Following concerns raised during discussion within the Working Group on Cosmetic Products and consequent call for data on these ingredients, the SCCS assessed the safety of Alpha-arbutin and Beta-arbutin in cosmetic products.

Read More »
cosmetic products

Request for SCCS Scientific Opinion on Citral

The European Commission requested the SCCS to assess whether the derived safe use levels for Citral by the application of the QRA2 based on the induction of skin sensitization is adequate to protect consumers. A period of 9 months was set for issuing the scientific opinion.

Read More »
cosmetic products

SCCS Scientific Advice on the Safety of Triclocarban and Triclosan

The European Commission Scientific Committee on Consumer Safety (SCCS) has published its preliminary version of the scientific advice on the safety of Triclocarban and Triclosan as substances with potential endocrine disrupting properties in cosmetic products. The deadline for comments was set at 27 May 2022.

Read More »
cosmetic products

Cosmetic Regulation in the Andean Community

In the Andean Community (Bolivia, Colombia, Ecuador and Peru), cosmetic products are mainly regulated by Decision 833. All cosmetic products made available in these countries must undergo a Mandatory Sanitary Notification (NSO) and need to be manufactured according to Good Manufacturing Practices (GMP).

Read More »
cosmetic products

Cosmetic Product Labelling in the European Union

The Regulation (EC) No 1223/2009 lays down the mandatory information that needs to be included in the packaging and container of a cosmetic products. In addition to this information, most cosmetic products include certain claims, which must be supported and properly substantiated.

Read More »
cosmetic products

Environmental Claims in the UK

Green claims are a trend among consumer goods and services. We often see claims like ‘clean beauty’, ‘environmental friendly’ and so many others. But how can companies ensure that these claims are not misleading? The UK’s Competition and Markets Authority (CMA) has published its Green Claims Code, in order to help companies comply with legal obligations when making environmental claims.

Read More »
cosmetic products

Parabens in Cosmetic Products

Parabens are widely used as preservatives in cosmetic and personal care products. Over the years, there have been some concerns related to the safety of parabens. The SCCS has published several opinions regarding the use of these ingredients in cosmetics, indicating the concentration levels they considered safe for human health. In the EU, some parabens can be safely used as preservatives, while others are prohibited in cosmetic products.

Read More »
cosmetic products

The Product Information File (PIF)

A Product Information File (PIF) is mandatory for all cosmetic products placed in the European Union market. It is a document that compiles the technical information of the cosmetic product and it must be kept for a period of 10 years by the Responsible Person.

Read More »
cosmetic products

How are Cosmetic Products Regulated in Australia?

The Australian Industrial Chemicals Introduction Scheme (AICIS) is the entity responsible for controlling cosmetics and soaps. Cosmetic ingredients are regulated as industrial chemicals under the Industrial Chemicals Act 2019, which is administered by AICIS.

Read More »