Medical Devices

Medical Devices

Medical devices are facing an increasingly complex regulatory environment. To get a product approved in Europe and the US a manufacturer has to take markedly different regulatory approaches into account. If the product is a combination of medicine and device the difficulties of interpreting the regulatory requirements increases even further.

With the stratification of indications many companies find themselves completely dependent on in-vitro diagnostic approaches to appropriately identify the right target population. This area is also going through tremendous regulatory change.

The consequences for biotech and pharmaceutical companies, as well as dedicated medical device manufacturers, of the increased complexities can be devastating. To address this, NDA has formed a new Medical Device Division to support companies address the regulatory requirements across the US and EU in an optimal manner.

We address the regulatory challenges inherent in the US system, as well as those in the new EU Medical Device and In-Vitro Diagnostics Regulations, in an integrated manner, relying on our experts across both jurisdictions.

Classifications & Borderline

With differing regulatory systems in Europe and US and the advances in technologies, the demarcation between the medical device and medicinal product and the correct classification of combination products are becoming increasing challenging.

EUUS

  • With differing regulatory pathways for medical devices and medicinal products, correct designation is imperative.

  • The new MDR brings a host of new challenges to manufacturers active in the European market

  • With a new Medical Device definition and a broader scope, more products are now included

  • New classification rules have also resulted in “upclassification” of some types of products


  • With multiple regulatory pathways in place, identifying the optimal path to approval in the US can be challenging

  • Misclassification is costly and time-consuming




NDA supports your classification through assessment of your product’s Primary Mode of Action and claims. We also assist you in the classification of your device, your discussions with the Notified Body and ensure that your argument is cohesive and credible.NDA supports classification and identification of the optimal path to market through review of your product’s Primary Mode of Action and claims. We assist you in your preparation, strategy and submission of 513(g) for information regarding classification and preparation for and filing of your Request For Designation (RFD).

Combination Products

As delivery system technology and medical device advances continue, the combination of drug-device and device-drug modalities is rapidly growing and the distinction between the modalities is becoming blurred. In some situations, it is difficult to discern the application type of the final product.

EUUS

  • In Europe, a product is either a device or a medicine which are regulated under two different regulatory systems with different requirements

  • Combinations of medicines and devices are common but there is no combination product classification in Europe

  • As a pharmaceutical company with a medical device component you must now engage with Notified Bodies, as well as your competent authority


  • Combination products may fall under more than one FDA Center due to their composition

  • There may be differences in pathway for each component that can impact the regulatory processes and final marketing application

  • Managing the regulatory interactions can be complex and challenging given the differences across FDA Centers and regulation

NDA supports all types of combination products, whether they are regulated as a medicine or as a medical device. Our medical device experts ensure professional management of the device component and constructive interactions with the Notified Bodies.NDA supports all types of combination products for the US and excels at managing the complex FDA pathways. We support companies from strategy pathway optimization through to filing of critical submissions and management of procedures and Agency meetings.

In-Vitro Diagnostics

In-vitro diagnostics are increasingly becoming essential to drug development and to other aspects of medical care. The increased stratification of patients to optimize the efficacy of medical treatments is enabled by sophisticated diagnostics, sometimes down to the genome level. For many companies, IVDs are essential to move their medicine to market and they are faced with challenges to understand how to navigate the regulatory landscape associated with these devices.

EUUS

  • The introduction of the IVDR presents an enormous challenge to IVD manufacturers

  • The introduction of a rule-based classification for IVDs mean that 80 -90% of IVDs including Companion Diagnostics will require Notified Body involvement.

  • Requirements for Clinical Evidence and Post Market Surveillance including Post Market Performance Follow up have increased


  • Just like other medical devices in the US, IVDs require thorough preparation and alignment with the regulatory requirements

  • Engaging the Agency at the right time and managing those interactions are crucial a successful market introduction

  • Ensuring effective management of key submissions is necessary to ensure timely approval

NDA supports your IVD activities from early gap assessment against the IVDR and development strategy, through to managing key submissions and Notified Body interactions.NDA supports IVD products in the US from the creation of a regulatory roadmap, through to managing your FDA interactions and your key submissions.

Quality Management

Quality Management for medical devices is becoming increasingly global and the increased requirements on the quality control have raised the bar for most device manufacturers. Ensuring that your Quality Management System is in line with the relevant regulation is not just a matter of compliance – without it you will not be allowed to sell your products.

EUUS

  • The MDR raises the bar for companies’ quality management systems

  • The new regulation expects a number of new processes to be managed, including, but not limited to, post-market surveillance, supply chain management, document retention and economic operators

  • Many companies have not yet thoroughly assessed their QMS to understand what they have to do to fulfill these expectations


  • The FDA has one of the most effective inspection functions in the world and carries out hundreds of inspections world-wide every year

  • Ensuring that your quality system is fit for purpose and compliant with the Agency’s requirements is your license to operate

  • Failure to meet the Agency’s requirements can result in withdrawal of your license to sell your product in the US



NDA supports companies with gap assessments and the necessary development activities to ensure a quality management system compliant with the MDR and IVDR and a practice that is both efficient and reliable.NDA supports companies to ensure there is a fit-for-purpose quality system in place. We assess it against current regulation, update it accordingly and conduct inspection-readiness checks in preparation of the FDA inspectors’ visits.

Need more information?

Contact us by email at info@ndareg.com or call now.