Medical Manufacturers are Exploiting a Grandfathering Clause in the Regulation to Postpone Implementation of EU’s New Rules

As Implant Files, an investigation by International Consortium of Investigative Journalists (ICIJ), have exposed failure of medical regulators to test faulty medical implants and save lives, companies are using an exemption clause to escape from EU’s new rules. The May 2020 Deadline for manufacturers who test medical devices to comply with recertification norms has led many companies to look for loopholes in the law.

EU instead of making new regulation is opting for stricter compliance of norms in the existing law.

ICIJ’s Implant files reported 4400 violations by device companies to report complaints and device problems in the last decade, the outrage ran across all sections of public opinion.

Companies are exploiting a grandfathering clause in the law to postpone recertification for another five years. European commission stated that the intention for the clause was to apply under some very specific conditions so that key products which could not make it up to the deadline wouldn’t have to be taken off the shelf. A clause which was meant to be a safe exit or a Plan B is being used by medical manufacturers to bypass implementation deadline.

The postponement of recertification will result in delay in access to critical medical devices to patients.   The grace period clause which allows companies to postpone recertification up to 2025 will not be feasible for the safety of patient as well as by transparency perspective, according to a senior member of EPF, A nodal patient advocacy group in Europe.

The Delay seems deliberate as MedTech, a lobbying firm for device makers warned of large scale discontinuation of vital medical technology products the healthcare industry has relied on for decades. In May 2018, just two years away from deadline, the firm replied with a negative response on whether recertification was on track. Concerned voices in European Parliament have shown skepticism about the new framework’s ability to effectively ensure compliance.

The medical device industry has around 27,000 players which collectively make 5, 00,000 products. Around a handful of 60 bodies which have been notified, has gained final approval from European commission to scrutinize and certify medical products according to safety standards. The regulation attracted criticism as the bodies which appointed certification are themselves waiting for final approval. The administrative lapses along with escapist attitude of companies has enraged patient rights and advocacy groups all over the continent.

Spain and Denmark seems to have taken the issue seriously and it was put on immediate agenda on Health Council in December last year. The commission having worked for decades to formulate these norms, can’t wait for another delay in its implementation, said Ellen Trane Norby, the Danish Health Minister.

About Sandali 225 Articles
A former journalist, Sandali is a content marketer with over 5 years of writing experience, across various industries including Food Innovation, Healthcare, and IoT and Technology. Sandali has been weaving corporate stories for organizations through different forms of impactful marketing content. Her key aim is to strategically align well-crafted narratives with business objectives, translating into a powerful communications platform for the company.