Amendments to the Transitional Provisions of the European Union MDR and IVDR
The proposed amendments aim to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework. The ammendments proposal aims to extend the current transition period (Article 120 of the MDR), and it also deletes the ‘sell-off’ deadlines of both MDR and IVDR. The extension is staggered depending on the risk class of the device - until December 2027 for high-risk devices and December 2028 for medium and lower-risk devices.

The Proposal Amendments

The proposal has 3 articles:

  • Article 1 – Amendments to Article 120(2), (3) and (4) and to Articles 122 and 123 of the MDR.
  • Article 2 – Amendments to Article 110(4) and to Article 112 of the IVDR.
  • Article 3 – Entry into force and application

Amendments to MDR

Transition period extension

The validity of the certificates issued under the Directives that were valid on 26 May 2021 was extended. If the certificates have already expired when the proposed amendment enters into force, the extension is only applicable if the manufacturer has a signed contract with a notified body for the conformity assessment at time of the expiry.

The transition period is extended until 31 December 2027 for higher risk devices (class III and class IIb implantable devices) and until 31 December 2028 for medium and lower risk devices (other class IIb devices and class IIa, class Im, Is and Ir devices).

The amendment also introduces a transition period until 26 May 2026 for class III custom-made implantable devices.

Conditions for the transition period

The extended transition period applies only to ‘legacy devices’.

Moreover, the application of the extended transition period is subject to the following cumulative conditions:

  • The devices must continue to comply with the Directives
  • The devices do not significantly change their design and intended purpose
  • The devices do not present an unacceptable risk to the health or safety of patients, users, other persons, or public health
  • No later than 26 May 2024, the manufacturer has put in place a quality management system (QMS) according to the MDR.
  • No later than 26 May 2024, the manufacturer has lodged a formal application for conformity assessment according to MDR, and no later than 26 September 2024 the notified body and the manufacturer have signed a written agreement

The devices covered by a certificate issued according to the Directives remain subject to appropriate surveillance by the notified body that issued the certificate. However, the manufacturer can agree that this becomes responsibility of the notified body designated under the MDR.

Deletion of the sell-off provision

Devices placed on the market before the end of the transition period can be made further available on the market without a legal time restriction.

Amendments to IVDR

Devices placed on the market before the end of the transition period (May 26 2027 for class A sterile and B, May 26 2026 for class C and May 26 2025 for class D) can be made further available on the market without a legal time restriction.

If you wish to get more information about the provisions of the EU-MDR and the EU-IVDR, feel free to contact us at info@criticalcatalyst.com.

European Commission Full Proposal

further
reading

cosmetic products

Citral under review: SCCS’s Preliminary Opinion

The SCCS was tasked by the European Commission to evaluate if the safety levels for Citral, determined through QRA2 based on skin sensitization induction, are sufficient to safeguard consumers. A preliminary opinion was released.

Read More »
news & updates

SCCS preliminary opinion on Citral sensitization endpoint

Ingredients: CITRAL

Date of publication: 27/03/2024

On March 27 2024, the Scientific Committee on Consumer Safety (SCCS) published the Preliminary Opinion on the safety of Citral in cosmetic products. The deadline for comments is set to June 2, 2024.

Read More »
cosmetic products

Are sunscreens with Benzophenone-4 safe?

Benzophenone-4 is commonly known as a UV-filter in cosmetic products. Learn what the final opinion of SCCS states about Benzophenone’s safety profile as a UV-filter in cosmetic products.

Read More »
cosmetic products

Is Aluminium in cosmetics safe for human health?

The Scientific Committee on Consumer Safety (SCCS) published its Final Opinion on the safety of Aluminium in cosmetic products. This follows a lengthy review process that began in 2013 when the SCCS was first mandated to evaluate the potential health risks of Aluminium (Al) and its compounds in cosmetics.

Read More »
cosmetic products

Silver in Cosmetics: SCCS preliminary opinion.

Ingredients: SILVER

The recent preliminary opinion from the Scientific Committee on Consumer Safety (SCCS) regarding silver in cosmetics is crucial for consumers and manufacturers. This article breaks down the key points, making it easier to understand the implications and stay informed.

Read More »
news & updates

EU Ecolabel adoption and recognition are on the rise

The Ecolabel certification is a comprehensive program focused on fostering sustainable practices. It evaluates products based on life cycle assessments, where every phase of said life cycle must abide by strict standards to attain the Ecolabel certification. The overarching objective of this certification is minimizing environmental harm from production or consumption activities.

Read More »
cosmetic products

UK proposes ban of wet wipes containing plastic 

The UK has proposed, on April 24, 2024, a regulation titled The Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2024, to the World Trade Organization (WTO). The regulation aims to eliminate the supply and sale of plastic-containing wet wipes, including cosmetic ones. The public can offer comments on the draft until June 23, 2024, with adoption expected in September of the same year.

Read More »
medical devices

Safety Reporting in Clinical Investigations: a Gap Analysis of Guidance Documents 

Safety reporting in clinical investigations of medical devices shall be performed in line with Article 80(2) of the EU MDR. On May 2020, it was published the MDCG 2020-10/1, outlining the procedures for safety reporting in clinical investigations of medical devices under the EU MDR. However, on October 2022 the Medical Device Coordination Group (MDCG) published an updated version of the MDCG 2020-10/1, the MDCG 2020-10/1 Rev 1. This article highlights the updates included in the new revision, analysing the gaps between both documents.

Read More »
medical devices

Roles and Responsibilities of an Authorised Representative under EU MDR and IVDR 

If a medical device manufacturer is not established in a Member State, the devices can only be placed on the Union market if the manufacturer designates an authorised representative. The authorised representative plays a pivotal role in ensuring the compliance of the devices with EU regulation, serving as point of contact. The obligations and responsibilities of authorised representative are outlined on Article 11 of both MDR and IVDR, but clarification of relevant requirements is described in MDCG 2022-16 of October 2022.

Read More »
medical devices

Understanding the ISO Standards Lifecycle

ISO Standards cover a huge range of activities, representing the distilled wisdom of people with expertise in their subject matter and providing the regulators with a sound basis to develop better legislation. ISO Standards are diverse, addressing from the shoe size we wear to the quality of air we breathe. The medical device sector is no exception. ISO has many International Standards and guidance documents aimed at helping the sector ensure safe and effective medical devices while meeting the multitude of national, regional and international regulatory requirements. But how exactly is a Standard developed, reviewed and withdraw?

Read More »