Euro Roundup: Team-NB updates best practices for MDR technical documentation submission

Notified body trade group Team-NB has revised its best practice guidance for submitting technical documentation under Annex II and II of the Medical Device Regulation (MDR). The European Association of Medical devices Notified Bodies (Team-NB) published the first version of the guidance in October.

In updating the guidance, Team-NB has expanded on the most common reasons for delays in the technical documentation review, explaining that “incomplete or inconsistent description of devices covered by the application and the related Technical Documentation” is a recurring problem.

The update (Version 2) also references sections of guidance from the Medical Device Coordination Group (MDCG) and provides more detailed overviews of the impact of that advice.

Pointing to two MDCG documents on device classification and software, Team-NB explains, “There should be a rationale for why the software is a medical device and for its classification,” adding that software can be divided into modules based on whether they have a medical purpose or not. Modules with a medical purpose must comply with the requirements of the MDR and must carry the CE marking.

Team-NB added new advice to sections on labeling and instructions for use, telling applicants to provide within the technical file a list of EU countries where their medical devices will be sold and “evidence that the national requirements of the languages used are adhered to.” If an applicant is yet to define its target EU markets, a master template in the language required by the notified body “may be acceptable.”

The document also features new best practices for electronic instructions for use (e-IFU). Team-NB notes instructions are “available on the website of the manufacturer in an official language(s) of the Union determined by the member state in which the device is made available” to ensure access to the e-IFU and facilitate the communication of updates.

Team-NB has shared new advice on design and manufacturing information, explaining that applicants need to “provide information to allow the design stages applied to the device to be understood.” The meeting minutes and reports created when companies close each phase of the design “can be informative enough.”

Team-NB plans to make additional changes to the document as notified bodies gain more experience with the process. The next revision is due in two years, although, as the release of the section version shows, the trade group will update the document sooner if needed.

Team-NB Guidance

UK imposes new restrictions on Roaccutane after review of psychiatric and sexual side effects

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has imposed more robust controls on the acne drug Roaccutane (isotretinoin) after reviewing evidence of mental health and sexual side effects that can continue after treatment has stopped.

Roaccutane, a Roche drug sold as Accutane in some other markets, is used to treat severe acne. MHRA called the medicine “an extremely effective last-line treatment for severe acne” and cautioned that “gaps in the available evidence meant that it was not possible to say that isotretinoin definitely caused many of the short-term or long-term psychiatric and sexual side effects.” Even so, MHRA sees a need for change.

“The individual experiences of patients and families continue to cause concern, and the [Isotretinoin Expert Working Group] emphasized the need to ensure patients are made aware of all risks before starting isotretinoin treatment, for there to be greater oversight of prescribing in young patients under 18 and for patients to be monitored more regularly for side effects,” MHRA wrote.

MHRA wants patients and their families to receive better information about the risks; consistent monitoring of a patient’s psychiatric and sexual health; tighter controls on first prescribing isotretinoin to people aged 12-18 years; patients to have more time to consider the benefits and risks fully; and more research into the side effects.

To use the drug in patients younger than 18 years, two prescribers must jointly agree that the acne is severe enough to justify treatment with isotretinoin and that other standard treatments have been sufficiently tried and found to be ineffective. Another working group will advise on adopting the recommendations and monitoring compliance with the rules.

Press Release, More

EMA targets June launch date for security multifactor authentication in clinical trial system

The European Medicines Agency (EMA) plans to implement multifactor authentication (MFA) for logging into the Clinical Trials Information System (CTIS) at the start of June.

MFA requires users to provide information and a password to access their accounts. The system can prevent unscrupulous actors from accessing accounts, even if they have gained access to a password. Given the importance of CTIS and the information it contains, EMA is taking steps to protect the system better.

Ahead of the introduction of MFA, the regulatory agency recommends that companies equip each user of CTIS with a mobile or an office phone that can be used for second-factor authentication. Users can set up MFA in the EMA ServiceNow portal today, but it will go live on CTIS in June.

EMA Report

Medicines for Europe calls for harmonized bioequivalence to aid generic drug development

Medicines for Europe, a trade group representing off-patent drugmakers, has called for resolving conflicts between new international bioequivalence requirements and existing documents.

The trade group commented in response to the International Council for Harmonisation’s (ICH) work on a new guideline, M13A, on bioequivalence requirements to approve medicines. Having revised the draft, Medicines for Europe identified a need to resolve “conflicting requirements between M13A and existing guidelines and product-specific guidance.”

Gerald Beuerle, chair of the Medicines for Europe bioequivalence working group, also emphasized the importance of maintaining the principle of extrapolation of bioequivalence results between populations and the need to clarify language on fed and fasting studies and pH dependency to avoid unnecessary studies.

Medicines for Europe see the ICH guidance as a way to “avoid the unnecessary repetition of bioequivalence studies when the comparator product is similar across highly regulated regions.”

Press Release

Other news:

EMA plans to gradually resume the publication of clinical data beginning in September 2023. The agency suspended the activity during the pandemic, except for COVID drugs and vaccines, but is now ready to resume. EMA is holding a webinar in May to discuss the relaunch. EMA Update

MHRA chair Stephen Lightfoot has resigned from his position effective 11 July. Lightfoot’s decision is “in line with his view that non-executives should not remain on any board for more than 8 years to maintain their independent thought and objectivity,” MHRA said. MHRA Notice

Euro Roundup: Team-NB updates best practices for MDR technical documentation submission

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