The roll out of (EU) MDR early next year is now a concern of nearly all that have or are developing medical devices. It has impact in areas that manufacturers, in the past, may not have had concern over. With the primary goal of ensuring timely access to innovative devices and balancing patient safety, it is extremely beneficial to seek the council of a regulatory professional as soon as possible.
The advice that a Regulatory Professional can offer is (but not limited to):
1. Clarifying if your product is a medical device under the new (EU) MDR. The definition is expanded in article 2 (notable examples include: Software as a medical device & cosmetics)
2. Advisement on the classification of your device, many of those classified as class 1 under the old Directive have changed in classification and are now classified as 2a, 2b, or 3.
3. Providing strategies that can save you time, effort, and money. Thus, getting your product to market in a manner that benefits your company and the end users.
4. Clarify the hefty weight placed on clinical evaluation, investigation and reporting. Including legacy devices and those on the market with no clinical data at all that will need this data in 2021.
5. Most importantly, training you for the new role of Persons Responsible for Regulatory compliance (PRRC). The role of the PRRC is outlined below. A role that is required and handles all aspects of conforming to the new legislation in addition to points 1 through 4 listed above.
Keep reading on for a brief explanation of just some of the tasks that a PRRC oversees, sign-up for our PRRC workshops and/or book an appointment directly with our Regulatory Advisor, Kami Faust.
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The new EU MDR Regulations, (EU) 2017/745 Medical Devices Regulation (MDR) & (EU) 2017/746 In Vitro Diagnostic Medical Regulation (IVDR), set consistent legislation across EU member countries and European economic area countries. The document is vast and comprehensive in its new definitions and classifications of what comprises a medical device.
In addition to refinement and clarity to standardize medical device adherence, a distinct regulatory position has been established and it is in Article 15 of the legislation where the requirements are laid out. This new role is the Persons Responsible for Regulatory Compliance or PRRC in short.
With the creation of the PRRC role, beginning early 2021, will come many responsibilities that will steer the development process of all medical devices. This will likely be in the form of maintaining critical regulatory documentation and Quality Management System (QMS) conformance.
The PRRC will have a major role in communication with the designated notified bodies; assessing conformity of the medical devices and a manufacturers’ compliance with their own QMS. The PRRC will need to grasp the interaction of key elements in the regulation to get the medical device (MD), or in vitro diagnostic medical device (IVDR) approved for market.
Given that much of the documentation will be supervised by the PRRC, a solid understanding of the role is necessary, and this will be provided in workshops offered by the Norway Health Tech Academy. Other aspects of the regulations that impact current business processes for manufacturing medical devices include clarifications of the old directives and make up for new technologies and materials since the last update to the directive. It will be the duty of the PRRC to understand these changes and ensure the implementation of them throughout the organization.
The PRRC will be vital in communicating these new regulations not as a barrier to market but as facilitators of quality and standard that ensure legal certainty, and traceability in all points of the device’s life cycle.
We at Norway Health Tech understand that the new legislation will be a challenging endeavor for most to enforce. Accordingly, our Regulatory Advisor, Kami Faust along with partner Obelis, has designed a set of workshops focusing on the responsibilities of the PRRC within medical device companies.
The objective of the workshops is to prepare those with the requisite background in regulatory work to act as a PRRC in their firm.
Information and registration for each program is stated in the following slides. Space is limited, so consider signing-up at your earliest convenience. Any questions or feedback can be directed to Kami Faust.
