Jama Software® is always on the lookout for news and content to benefit and inform our industry partners. As such, we’ve curated a series of articles that we found insightful. In this blog post, we share content sourced from Regulatory Focus – Euro Roundup: MDCG publishes guidance on MDR, IVDR authorized representative requirements – originally published on November 4, 2022, and written by Nick Paul Taylor.
According to this EU survey, 17,095 valid medical device and IVD certificates are set to expire in 2024 and 2025. Now is the time to get your requirements management and documentation in order, so you’re in the best position to meet with notified bodies and update your certification.
Euro Roundup: MDCG publishes guidance on MDR, IVDR authorized representative requirements
The Medical Device Coordination Group (MDCG) has published guidance on the role and requirements of authorized representatives under the new medtech regulations. In the guidance, MDCG unpacks what the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) mean for authorized representatives, manufacturers and other economic operators.
EU regulations require manufacturers without a presence in a member state to appoint a sole authorized representative who serves as their EU contact person and is central to ensuring compliance . MDR and IVDR outline the obligations of authorized representatives and enhance their responsibilities.
“The manufacturer and the authorized representative are free to configure the structure of their contractual relationship as they see appropriate, as long as there is a written mandate that meets the minimum requirements of Article 11(3) of the Regulations and the content of which is agreed between the parties. A mandate should be drawn up irrespective of whether the authorized representative is independent/outside of or is part of the same larger organization as the manufacturer,” according to the guidance.
Article 11(3) requires the authorized representative to perform tasks specified in their mandate with the manufacturer. Upon request, the authorized representative must provide a copy of the mandate to the competent authority. The article also describes the minimum tasks that the mandate should cover, but the authorized representative can agree to take on additional activities. Certain responsibilities cannot be delegated by manufacturers to authorized representatives.
The responsibilities of authorized representatives include verifying the existence of EU declaration of conformity and technical documents and, if applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer. Authorized representatives may inform their manufacturers if they have reason to believe the conformity assessment procedure is inappropriate for the device in question. Other tasks include keeping a copy of the EU declaration of conformity.
Authorized representatives need to comply with the registration obligations set out in MDR and IVDR, for example by registering their details in EUDAMED. The regulations require authorized representatives to update their information within one week of a change.
Related: Understanding Integrated Risk Management for Medical Devices
Trade groups slam wastewater treatment proposal
Three pharma trade groups have warned that EU proposals on wastewater treatment will jeopardize access to medicines without helping the green transition.
The Commission sees applying a “polluter pays” policy to the pharmaceutical and cosmetics industries as a fair response to evidence that the sectors “are jointly responsible for 92% of the toxic load in wastewaters,” notably because there is “sufficient evidence on the existence of micropollutants from these products in wastewater and there are treatments to remove their harmful residues.”
AESGP, EFPIA and Medicines for Europe, trade groups that represent different types of drugmakers, see things differently. In a joint statement, the bodies branded “blanket levies on medicinal products based on patient excretion levels” as “unprecedented, disproportionate, unfair and ineffective.” The trade groups warned the proposal will be “very detrimental to society, if increased burdens on companies mean that many essential medicines are no longer viable and result in shortages.”
“It is frustrating that duplicative and unworkable proposals for levies on medicines to address wastewater management are thrown at the pharmaceutical industry. This undermines our efforts to reduce our environmental footprint and more worryingly, negatively impact patients who need medicines. It is a lose-lose proposal,” said Adrian van den Hoven, director general at Medicines for Europe.
Few active pharmaceutical ingredients pose risks to the environment and “these are very well under control given the concentration levels found in European waterways,” according to the joint statement. As “pharmaceuticals are only a small fraction of the substances that an improved wastewater treatment would remove,” the proposal would see drugmakers finance wastewater treatment upgrades that would remove micro-pollutants from other “unaccounted” sources of water contamination.
PRAC recommends restricting use of JAK inhibitors in inflammatory disorders
The Pharmacovigilance Risk Assessment Committee (PRAC) has proposed restricting the patients who receive JAK inhibitors for chronic inflammatory conditions to mitigate risks linked to the molecules.
JAK inhibitors including AbbVie’s Rinvoq and Pfizer’s Xeljanz are used to treat inflammatory conditions such as rheumatoid arthritis. However, regulators are wary of the side effects caused by the class of molecules, leading the US Food and Drug Administration to apply boxed warnings and PRAC to review the EU rules to ensure the benefits outweigh the risks.
The European Medicines Agency (EMA) committee recommends that patients aged 65 years or above, people at increased risk of major cardiovascular problems, individuals who smoke or have done so for a long time in the past, and those at increased risk of cancer should generally receive other treatments. Those patients should use JAK inhibitors only in the absence of suitable alternatives.
PRAC’s proposed restrictions reflect the findings of a clinical trial of Xeljanz, which linked it to a higher risk of major cardiovascular problems, cancer, venous thromboembolism, serious infections and death than TNF-alpha inhibitors. Some developers of JAK inhibitors have sought to differentiate their molecules based on safety, but the PRAC recommendation covers five drugs for chronic inflammatory disorders.
Related: FDA New Draft Guidance of Premarket Submissions for Medical Devices: Are you ready?
PRAC Notice, More
Notified body survey quantifies the 2024-25 bottleneck for medical device, IVD certifications
An EU survey has revealed the number of medical device and IVD certifications that are set to expire in 2024 and 2025, respectively. Notified bodies have identified the years as a potential bottleneck in the transition to MDR and IVDR.
While the EU has countered the threat of MDR and IVDR causing near-term supply disruption, the delays have potentially only pushed the problems out by a few years. The EU survey of notified bodies shows that 17,095 valid certificates issued under the old device directives will expire in 2024, compared to 1,387 this year and 4,311 in 2023.
As of October, companies had filed 8,120 MDR applications, up from 6,188 in April. Applications are growing faster than MDR certifications, which rose from 1,069 in April to 1,990 in the latest survey.
EDQM strikes agreement with EU to support substances of human origin regulatory framework
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has agreed to enhance its cooperation with the EU on substances of human origin (SoHO) such as blood, organs, tissues and cells.
Under the terms of a jointly financed agreement that will run to 2024, EDQM will “contribute to providing all Council of Europe member states, including the EU 27, with a coherent European regulatory SoHO framework and to supporting professionals of the sector in implementing this framework and in strengthening their SoHO systems.”
The agreement builds on decades of collaboration with the EU, including technical cooperation on SoHO that dates back more than 10 years. EDQM and the EU framed the expanded scope of the agreement to make “the best use of their respective strengths and resources.”
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