Euro Roundup: EU answers questions about extension of MDR transition, removal of ‘sell off’ periods

The European Commission has answered questions on “practical aspects” related to legislation to extend the transition period for the Medical Device Regulation (MDR). In the question-and-answer document, the Commission clarifies the scope of the extension and how companies can benefit from the changes.

Across the 10-page text, the Commission answers 18 questions about the applicability of the revised transitional period to custom-made devices, how to show a legacy device benefits from the extension and more. The topics range from broad points, such as the fact that only legacy devices can benefit from the extended transitional period to interrogations of specific phrases used in the legislation.

Specific points addressed by the Commission include how to interpret the phrase a “device intended to substitute that device.” Experts sought clarification of the new concept after seeing the wording of the extension agreement and have now received additional information in the Q&A (RELATED: European Parliament votes to extend MDR transition period, Regulatory Focus, 16 February 2023).

“A device intended to substitute the legacy device will usually (but not necessarily) differ from the legacy device because the manufacturer has made (significant) changes with regard to its design or intended purpose with a view to replacing the legacy device,” the Q&A states. “It is the responsibility of the manufacturer to determine the device that is intended to substitute a legacy device and to explain the link to the substituted legacy device. The substitute device will need to undergo the full MDR conformity assessment before it can be placed on the market.”

While the recently passed legislation largely applies to MDR, it also has some implications for the In Vitro Diagnostic Regulation (IVDR) that are covered in the Q&A. The implications relate to the removal of the “sell-off” date.

As the document explains, IVDs that were placed on the market under the old directive or are made available during the IVDR transition period “may continue to be made available on the market or put into service without any limitation in time without prejudice to the device’s possible shelf-life or expiry date.” Similar provisions apply under MDR.

On the day the Commission published the Q&A, the UK Medicines and Healthcare products Regulatory Agency (MHRA) released a statement about the European Union’s extension of CE certificates. While the UK has left the EU, the extension to the transition period will apply automatically in Northern Ireland under the terms of the Brexit deal. Changes to the validity of certificates issued under the old directives also apply in Northern Ireland. MHRA will update its registration guidance to reflect the changes.

Q&A Document, MHRA Notice

Politicians accuse Commission of ‘giving in to industrial pressure’ as pharma reform delayed again

The European Commission’s decision to delay the publication of pharmaceutical legislation for a third time has triggered a backlash from some politicians, with one saying the body “seems to be once more giving in to industrial pressure.”

When the European Commissioner for Health and Food Safety discussed the legislation two weeks ago, the expectation was that officials would publish the draft this month (RELATED: Commission delays notified body reassessments to free up capacity for MDR, IVDR, Regulatory Focus, 16 March 2023). However, last week members of the European Parliament (MEPs) learned, and EURACTIV reported, that the Commission has pushed back the publication of the legislation for a third time.

“We all know that this legislative package was ready to be published. We all refrained in the past weeks to comment on the leaked version of the proposals,” French MEP Véronique Trillet-Lenoir wrote in a letter to Ursula von der Leyen, the president of the Commission. “The Commission now seems to be once more giving in to industrial pressure.”

The MEP said the delay “without any justification” or alternative date of publication is “unacceptable”, a view that was echoed by some of her peers. German MEP Tiemo Wölken called the delay “a huge victory for the pharmaceutical lobby” and “an embarrassment” for the Commission, adding that officials seem to have bowed to “the American style pressure coming from industry.”

Delaying the release of the draft raises doubts about whether the legislation can be finalized by the end of the legislative mandate in 2024. Trillet-Lenoir called for the Commission to release the draft in April.

EURACTIV, Trillet-Lenoir Letter

Swissmedic finds 70% of Class I device makers fail to meet postmarket surveillance requirements

An investigation by the Swiss Agency for Therapeutic Products (Swissmedic) has found widespread noncompliance with postmarket surveillance requirements among manufacturers of Class I medical devices.

In May 2021, the rules that apply to Swiss manufacturers of low-risk products changed. To assess compliance with the revised requirements, the regulator inspected 27 manufacturers in Switzerland. The inspections revealed problems, including the fact that 70% of the post-market surveillance documents it reviewed failed to meet legal requirements.

The noncompliant manufacturers were unable to demonstrate continuous and systematic surveillance of their devices on the market, typically because of issues related to data collection and the evaluation of incidents and trends. Swissmedic gave the manufacturers the opportunity to remedy the failings and will monitor the corrective actions. Additional measures await companies that fail to fix the issues.

Swissmedic also found that 14% of the manufacturers had not registered with it at the time of the review and the agency was yet to be correctly notified of 39% of the Class I devices. The failings were dealt with during the review.

The investigation showed 11% of the manufacturers whose declarations of conformity were reviewed were unable to show they met the requirements for placing devices on the market. Most manufacturers corrected the problem but others were prohibited from placing the affected devices on the market.

Swissmedic concluded that “manufacturers of Class I medical devices are not adequately implementing the Medical Devices Ordinance, despite it having been in force for 18 months.” The regulatory agency has no indication that compliance at foreign manufacturers is better and expects the Swiss Database on Medical Devices to increase transparency once it goes live.

Swissmedic Report

Commission asks risk committee to update guidance on use of phthalates in medical devices

The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) is set to update its guidance on the use of phthalates in certain medical devices considering developments since the current text was adopted in 2019.

Phthalates, chemicals used to make plastics more durable, can be carcinogenic, mutagenic or have endocrine-disrupting properties. As such, their use of in invasive devices, those that come into direct contact with the human body or those that are used to administer or transport medicines is covered by benefit-risk assessment guidelines.

Under MDR, there is a legal obligation to update the guidelines at least every five years. SCHEER is set to adopt the updated guidance by June 2024. If SCHEER finds the current guidance “is still fit for purpose in the light of the latest scientific evidence,” it will issue a new version of the document that confirms the continued applicability of the text.

SCHEER Notice

Other news:

The UK government has defended the £10 million ($12 million) MHRA is set to receive over two years as enough to “implement swift new approvals processes” after the opposition party questioned whether the regulatory agency will have enough money to have a fully operational approval process in place by 2024. Written Response

Euro Roundup: EU answers questions about extension of MDR transition, removal of ‘sell off’ periods

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