Monthly Archives: August 2020

PMCF Planning as per EU MDR

Clinical Trials

As the Medical Device Regulation (MDR) deadlines are approaching for re-certification and/or introduction of new products, manufacturers are also working to start or fulfil the Post-market Clinical Follow-up (PMCF) activities as per requirements set out in Annex XIV, part B of the MDR.

The Annex states “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post-market surveillance plan”.

The purpose of PMCF is:

a) to gather information regarding:

  • rare complications
  • clinical observations only seen in a larger user/patient population
  • clinical observations only seen after long-term use of the device

b)  verification of clinical risk-benefit analysis conclusions

PMCF requirements as per EU MDR

A successful PMCF plan ensures that safety and performance results are continuously available to the market. PMCF should be carried out to proactively collect and evaluate clinical data per the method laid out in the PMCF plan which aims at:

  • confirming the safety and performance throughout the product lifecycle
  • identifying risks and previously unknown side-effects while continually monitoring already identified side-effects and contraindications,
  • ensuring the continued acceptability of the benefit-risk ratio, and
  • identifying off-label uses of the device, while ensuring the intended purpose is correct in the environment it is supposed to be used.

If through PMCF, the need for preventive and/or corrective measures has been identified, the manufacturer must implement them and update the post market surveillance report accordingly.

Therefore, PMCF plan specifies the methods and procedures that will be used to proactively collect and evaluate clinical data in relation to the product’s safety as well as clinical performance.

PMCF Planning Pitfalls

Some of the most common pitfalls in planning a prospective clinical PMCF plan are: 

a) Time-consuming ethical approval

Overall delay in planning a PMCF study might happen due to requirement of approval from ethical committees, which can be a time-consuming task as requirements may vary from country to country.

b) GDPR Compliance

The GDPR is a comprehensive regulation which can help identify the safety, performance, and risk profile specific to your device. The key to compliance lies in selecting systems that guarantee the correct security and safety measures and obtaining clear informed consent from respondents/patients. 

c) Key Opinion Leaders

It is important to collaborate with a network of key opinion leaders in the region you are seeking approval as conducting as planning a PMCF study requires correct and relevant data reported to ensure the safety and performance profile of the device is rightly captured. Clinical experts in the region can help assess and guide these requirements as they have expertise in the filed due to their exposure to working with such devices.

 

Medical Device Industry and COVID-19: Regulatory Modifications to Consider

Medical Devices, , , , , , , , , , ,

Background

The COVID-19 outbreak is a public health crisis that this generation has never seen before and has presented itself as an unprecedented challenge to the health industry including the Medical Device and Regulatory framework.

There is tremendous burden being faced by first responders and health institutions. Simultaneously, there is increasing pressure on national authorities, EU member states, and economic operators to supply vitally important medical devices at the time of adoption of Regulation (EU) 2017/745.

The unanticipated crisis has had a significant impact on placing devices on the market in the Union while halting the designated work of the notified bodies. The commission recognizes the role of Personal Protective Equipment (PPEs) such as medical gloves, surgical masks, and equipment for intensive care in the current pandemic and has therefore decided to prioritize the demands of such equipment thereby avoiding any potential market disruption.

MDR defers till 2021

Therefore, the European Commission released a proposal earlier in April to defer without any alterations to the guidelines, the enforcement of the EU Medical Devices Regulation (MDR) for a year, applicable from May 26th, 2020. However, the commission made no deferments for the In Vitro Diagnostic Regulation (IVDR), which will be applicable from May 26th, 2022. The aim of the deferment has been to ease the pressure on the medical fraternity to be able to cope and focus with the current crisis and minimize risk to medical professionals.

National Derogation

In scenarios of a public health crisis, such as COVID-19 the Regulation (EU) 2017/745 allows the commission to extend the validity of a national derogation for a limited period of time in exceptional cases for member states in response to address Union-wide shortages of vitally important medical devices in an effective manner.

The Commission has agreed with the European standardization organization to make originally copyright standards (including EN 149 and 14683) freely and fully available by the national standardization bodies. Manufacturers can download a copy for free from the online catalogues of the national standardization bodies.

Furthermore, Directives 90/385/EEC and 93/42/EEC of the regulation empower national authorities on duly justified requests to place medical devices on the market for whom relevant conformity assessment has not been completed but substantial evidence is available to prove interest of public health, patient safety, and health.

Market approval of devices without CE marking

In exceptional circumstances, products can be placed on the market even if no CE marking has been affixed upon them, given that the following conditions are fulfilled:

  • The products manufactured are in accordance with one of the EN standards or other standards referred to in the WHO guidelines
  • The products are part of a purchase organized by the relevant Member State authorities;
  • The products are only made available for the healthcare workers;
  • The products are only made available for the duration of the current health crisis; and
  • The products are not entering the regular distribution channels and made available to other users.

This approval, may bring some relief from the intense pressure on manufacturers to complete the MDD/AIMDD work by giving them an additional year while ensuring devices reach hospitals. Meanwhile, the European parliament and the Council continue to work together to adopt the legislation as mandated implementation date.

Take home message

It is important to note and acknowledge that the framework of manufacturers, regulatory bodies, and agencies continue to work on collaborating and collectively contributing in ensuring that medical devices are used safely amongst patients in this evolving pandemic.

Turacoz Healthcare Solutions understands medical device regulatory requirements and can assist you in your device approval journey. Our technical writers are experienced industry experts having worked with EMA, FDA and other regulatory agencies in gap analysis, device approval and regulatory queries responses. In addition to the regulatory services, the team also provides publication, medi-marketing and advisory board meetings for medical device companies.

If you have any queries, email us at [email protected].