Welcome to 2017. With the new year rolling in, here come new resolutions … or should we say new Regulations.
In June 2016, political agreements on the medical device and in vitro diagnostics medical device regulations were released and we are expecting these two new European regulations to be voted and published during the year 2017.
These two regulations are bringing numerous changes, so it is crucial for manufacturers, who will be impacted by these changes, to be ready.
For this first newsletter of the year, we will present 5 major changes for each regulation, based on the published political agreements.
Medical Device Regulation (MDR)
This regulation is more directive and prescriptive and introduces some changes, so all medical device manufacturers will have to review their procedures and the supporting data of their devices to ensure compliance with the new regulation requirements by the end of the 3-year transition period.
Here are 5 questions, to jump start the transition process.
Is my device covered by the new European Medical Device Regulation (MDR)?
As part of the change from the current directive, the new regulation will cover medical devices and active implantable medical devices under a single text. Furthermore, a series of definition will be updated which will lead to a significant extension of the scope.
Among the changes, we have identified the inclusion of products without an intended medical purpose (Annex XV of the MDR), such as cosmetic implants, contact lenses, and cosmetic laser products, the revision of the definition of custom-made devices, and the extension of the “accessory” definition to include devices that specifically or directly assist another device in its intended purpose.
The new Regulation will therefore apply to devices not previously covered by the Medical Device Directive.
Does the class of my device remain the same?
The classification system for medical devices will remain the same with four classes (I, IIa, IIb, and III); however, the classification rules will be modified and some devices will fall into a higher class.
Manufacturers will have to carefully review the class of their devices, as additional supporting data for current CE marked products may be required in order to be in compliance with the regulation.
Among the classification changes, we identified partial and articular implants, spinal discs and implants in contact with the spinal column, accessories of active implantable devices; all of which have been up-classified to class III.
Are clinical evidences supporting the CE marking of my device sufficient to comply with the MDR?
The regulation introduces new concepts regarding clinical evaluation and investigation. So, medical device manufacturers of CE marked devices will have to perform gap analysis to determine the need for additional data.
Among the changes, we identified new requirements to be able to use already CE marked devices as predicate device, new conditions and requirements to perform clinical investigations, new requirement to provide, in layperson’s terms, a summary of clinical evaluation for high-risk devices and permanent implants.
Manufacturers will also have to revise their post-market surveillance program to be in compliance with new requirements, among them, mandatory performance of periodic safety update reports and post-market clinical follow-ups.
Could I keep the same Authorized Representative, Distribution, and Supply chain agreements?
The second chapter of the regulation defined general obligations for the manufacturer, but also for importers, distributors, and the Authorized Representative.
Because all actors of the commercialization of the device will have their own regulatory responsibilities, such as duty to check compliance of the device, current agreements with these actors may need to be revised.
Similarly, responsibilities of Authorized Representatives will be extended; the regulation clearly states that tasks performed by the authorized representative shall be specified in a mandate agreed with the manufacturer.
Will I have to acquire more resources?
The regulation calls for a person responsible for regulatory compliance with the requisite expertise in the field of medical devices. This person will have to be a full time employee within the organization or, for micro and small manufacturers, a person outside of the organization but permanently and continuously at their disposal.
In Vitro Diagnostic Medical Device Regulation
This regulation introduces a revolution in the IVD industry and European requirements for IVD products, which could explain the 5 years transition period between the IVDD and the IVDR. It is important for manufacturers impacted by this change to analyze and carefully plan the transition to ensure a successful and smooth implementation.
Here are 5 questions to kick start the analysis process.
Is my device covered by the new European In Vitro Diagnostic Regulation (IVDR)?
The first noticeable change is the extension of the IVDR scope compared to the current IVDD. According to the multiple definitions introduced, numerous devices will now be covered by the new regulation.
Good examples are the inclusion of the genetic tests, companion diagnostic (CDx) and software and services like distance sales which are performed outside the European Union for a proposition of a diagnostic or therapeutic service to European Union citizens.
The “accessory” scope is extended and will include articles that specifically and directly assist the medical functionality of the medical device in view of its intended purpose.
What is the class of my IVD device?
Arguably, the most significant change is the new classification system. Moving from a list-based defined by the directive, the regulation will introduce a risk-based classification.
All IVDs will now be separated into four risk classes from class A, for devices with low risks, to class D, for devices with high public and patient risks. Most devices that are in list A and B under the current directive will be in classes C and D in the future regulation.
In order to determine the risk class of a device, manufacturers will have to refer to seven (7) rules presented in Annex VII of the regulation. It is crucial for manufacturers to adequately classify their products as it will dictate the level of information to collect and analyze to be in compliance with the regulation.
Which conformity assessment route should we follow?
Under the current directive, 20% of IVD devices require a conformity assessment by a notified body, the rest of the devices being self-certified. With the regulation, the situation will be reversed; going forward, 80% of all IVD devices will require an assessment by a notified body to demonstrate conformity to the IVDR. Only class A devices will be self-certified (with the exception of sterile devices).
The assessment route to follow is directly related to the device classification:
Class B: Full Quality Management System assurance (Annex VIII).
- Full Quality Management System assurance (Annex VIII) with assessment of Technical Documentation selected on a representative basis.
- Production Quality Assurance (Annex X) with EC Type examination – Technical Documentation (Annex IX).
- For Companion Diagnostics an additional consultation with the competent authority will be required.
- Full Quality Management System assurance (Annex VIII) with assessment of Technical Documentation selected on a representative basis and batch verification.
- Production Quality Assurance (Annex X) with EC Type examination – Technical Documentation (Annex IX) and batch verification.
What kind of clinical data will be required to support CE marking?
Under the IVDR, all IVD devices will require clinical evidence which means the clinical data and performance evaluation results. For all devices, manufacturers will have to support for the performance evaluation with: the scientific validity, analytical performance and clinical performance of the device.
The clinical evidence shall support the intended purpose of the device as stated by the manufacturer and be based on a continuous process of performance evaluation. Because this will apply to devices currently on the market, it is crucial for manufacturers to determine the nature and type of information required and plan how to generate them in a timely manner to ensure that these devices will be compliant with the new regulation and maintain their CE marking. For more information, consult our newsletter and webinar on Clinical evidence requirements of In vitro Diagnostic Devices in the future EU IVD Regulation.
How to present all data supporting the product CE marking?
As it is required by the current directive, the Technical Documentation will be the backbone of each IVD device and will be used by manufacturers to demonstrate the conformity of their products.
However, the regulation is more detailed and prescriptive of the content of the Technical Documentation (Annex II of the IVDR). It will be important for all manufacturers to perform a gap analysis of their current Technical Documentation in order to plan, collect, analyze and record all necessary data during of the transition period.
Are these all the changes of the European Medical Device Regulation and In Vitro Diagnostics Regulation?
This information is an overview of some of the major changes introduced by these regulations and in addition to this newsletter we will explore more changes, via webinars throughout the coming year … So stay tuned!
|About the Writer|
Julien Sénac, Ph.D.