MDR
for Manufacturers OF
medical device
Your medical PRODUCTION
in the EU market
in the EU market
Background information about
Medical Devices Regulation
The new Medical Devices Regulation (2017/745/EU) (MDR) and the In Vitro Diagnostic Medical Devices Regulation (2017/746/EU) (IVDR) bring EU legislation in line with technical advances, changes in medical sciences and progress in regulatory areas.
The new Regulations create a robust, transparent and sustainable regulatory framework that is internationally recognized, will improve clinical safety and create equal market access for manufacturers.
Unlike the Directives, the Regulations are not subject to implementation into national legislation. Thus, MDR and IVDR will reduce the risks of interpretation discrepancies in the EU market
Transitional periods are provided for the smooth application of the new Regulations. However, you should keep in mind that as the deadline approaches, consultants, local specialists and notified bodies will be busier.
What does this mean in practice?
The MDR will replace the current Medical Devices Directive (93/42/EEC) (MDD) and Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD).
The MDR was published in May 2017, marking the start of a four-year transition period from MDD and AIMDD.
1During the transitional period, the MDR will come into effect in stages, starting with provisions related to the appointment of notified bodies and the acquisition of new certificates by manufacturers under the MDR Regulation..
2The transition period will end on May 26, 2021, which is the effective date (DDA) of the Regulation.
From that date, the MDR Regulation will apply in full.
3
Who is responsible for the compliance of the manufacturer and his products with the requirements of the EU regulation
MDR 2017/745
Who is responsible for the compliance of the manufacturer and his products with the requirements of the EU regulation
MDR 2017/745
According to the requirements of the EU regulation MDR 2017/745, every manufacturer of medical devices that sells its products in the EU must have at its disposal a person responsible for the compliance of the manufacturer and his products with this regulation. Officially, such a person is called Person Responsible for Regulatory Compliance, abbreviated as PRRC. The requirement for a PRRC is set out in paragraph 34 of the general provisions of the MDR and, in more detail, in article 15 of the MDR.
There is no way to avoid this new European requirement, because the presence of a PRRC is required for registration in the EUDAMED system.
And if a product class is subject to verification by a Notified Body, then the presence of a PRRC will be one of the first things it will check!
Tasks of the person responsible for MDR compliance:
Compliance with the PRRC must be documented, the PRRC must have:
• a document of education (diploma, certificate, etc.), corresponding to the European standard, in the field of medicine, pharmaceuticals, biotechnology or other relevant discipline, and have experience in the regulatory field or quality management for medical devices - at least 1 year.
•or at least four years of experience in regulatory matters or quality management for medical devices.
Who can act as the person responsible for MDR compliance (PRRC) in the enterprise?
! It is not necessary for a medical device manufacturer to introduce a new staff position or sign a separate employment contract with PRRC in order to comply with the requirement of European legislation regarding PRRC.
The person responsible for MDR compliance is not a position, but a function. And any employee who meets the minimum requirements of the PRRC can perform this function.
Moreover, under certain conditions, the person responsible for MDR compliance may not even work for the company
IF a manufacturer does not have workers meeting the minimum requirements for a PRRC position and is a micro or small business, the company may hire a qualified third party (such as our company) to perform all PRRC tasks.
There is no way to avoid this new European requirement, because the presence of a PRRC is required for registration in the EUDAMED system.
And if a product class is subject to verification by a Notified Body, then the presence of a PRRC will be one of the first things it will check!
Tasks of the person responsible for MDR compliance:
- Ensure that MDR products are verified as part of the company's quality management system
- Ensure the creation and maintenance of up-to-date technical documentation of products
- Provide post-marketing (post-registration) surveillance in accordance with Article 10 of the MDR
- Ensure that adverse events are reported to EU supervisory authorities in accordance with Articles 87 and 91 of the MDR
- When conducting clinical trials, ensure compliance with section 4.1 of Chapter II of Appendix XV of the MDR
Compliance with the PRRC must be documented, the PRRC must have:
• a document of education (diploma, certificate, etc.), corresponding to the European standard, in the field of medicine, pharmaceuticals, biotechnology or other relevant discipline, and have experience in the regulatory field or quality management for medical devices - at least 1 year.
•or at least four years of experience in regulatory matters or quality management for medical devices.
Who can act as the person responsible for MDR compliance (PRRC) in the enterprise?
! It is not necessary for a medical device manufacturer to introduce a new staff position or sign a separate employment contract with PRRC in order to comply with the requirement of European legislation regarding PRRC.
The person responsible for MDR compliance is not a position, but a function. And any employee who meets the minimum requirements of the PRRC can perform this function.
Moreover, under certain conditions, the person responsible for MDR compliance may not even work for the company
IF a manufacturer does not have workers meeting the minimum requirements for a PRRC position and is a micro or small business, the company may hire a qualified third party (such as our company) to perform all PRRC tasks.
reference: According to EU standards, micro-enterprises and small enterprises include companies with less than 50 employees and an annual revenue of less than 10 million euros
i
If the company is not a micro or small enterprise, you must find an employee with a minimum PRRC qualification in your state, or hire such an employee.
How to organize the work of PRRC?
1) The main legislative requirement regarding the organization of the work of the PRRC is the absence of any obstacles on the part of the company and its management that impede the implementation of the tasks of the PRRC.
In practice, this means that the PRRC must have access to all the resources it needs to carry out its tasks, including information.
This applies to both internal and external PRRCs.
2) There is also the option that the "MDR Compliance Officer" is actually multiple individuals, each taking on a separate PRRC function. In such a situation, it is important to observe two conditions:
•Together, the functions of all individual workers should overlap all mandatory PRRC tasks.
• The functions of all individual workers must be properly documented.
How to organize the work of PRRC?
1) The main legislative requirement regarding the organization of the work of the PRRC is the absence of any obstacles on the part of the company and its management that impede the implementation of the tasks of the PRRC.
In practice, this means that the PRRC must have access to all the resources it needs to carry out its tasks, including information.
This applies to both internal and external PRRCs.
2) There is also the option that the "MDR Compliance Officer" is actually multiple individuals, each taking on a separate PRRC function. In such a situation, it is important to observe two conditions:
•Together, the functions of all individual workers should overlap all mandatory PRRC tasks.
• The functions of all individual workers must be properly documented.
Clinical evaluation and PMCF
Clinical evaluation and PMCF
Conducting clinical evaluation is one of the main requirements of MDR 2017/745, which applies to all manufacturers and to all classes and types of medical devices (including class I). Accordingly, whatever medical devices you sell in the European Union, you need to conduct a clinical evaluation of these devices.
What is clinical evaluation of a medical device
When is clinical evaluation of a medical device performed?
Clinical evaluation is carried out at the stage of obtaining CE-marking for a medical device - then clinical data should be regularly updated as part of the post-marketing clinical follow-up process (PMCF - post-market clinical follow-up). If you are already CE marking your product, but have not yet completed a clinical evaluation, you should do so.
! Lack of clinical assessment is a serious violation of MDR requirements.
Who is eligible to conduct a clinical assessment
Clinical evaluation should be carried out by a person or persons who have the necessary qualifications.
The main requirements for an expert conducting a clinical assessment are as follows:
•Medical or related education and at least 5 years of professional experience
•Knowledge of scientific methodology, experience in clinical trials and biostatistics
•Documented ability to work with scientific information
•Knowledge of regulatory requirements for medical devices in the European Union
•Experience in writing medical texts (articles, reviews, etc.)
How is clinical evaluation of a medical device performed?
Clinical evaluation should be based on a clear scientific methodology, which should be described in the Clinical evaluation plan. The outcome of the clinical evaluation conducted in accordance with this plan is a Clinical evaluation report.
The main data analyzed in the clinical evaluation process are as follows:
• Results of clinical trials of a medical device
• Results of studies of equivalent medical devices (equivalence must be justified)
•Data published in the scientific literature regarding comparable medical devices
• The analysis and conclusions of the clinical assessment should be well structured and evidence-based.
When is clinical evaluation of a medical device performed?
Clinical evaluation is carried out at the stage of obtaining CE-marking for a medical device - then clinical data should be regularly updated as part of the post-marketing clinical follow-up process (PMCF - post-market clinical follow-up). If you are already CE marking your product, but have not yet completed a clinical evaluation, you should do so.
! Lack of clinical assessment is a serious violation of MDR requirements.
Who is eligible to conduct a clinical assessment
Clinical evaluation should be carried out by a person or persons who have the necessary qualifications.
The main requirements for an expert conducting a clinical assessment are as follows:
•Medical or related education and at least 5 years of professional experience
•Knowledge of scientific methodology, experience in clinical trials and biostatistics
•Documented ability to work with scientific information
•Knowledge of regulatory requirements for medical devices in the European Union
•Experience in writing medical texts (articles, reviews, etc.)
How is clinical evaluation of a medical device performed?
Clinical evaluation should be based on a clear scientific methodology, which should be described in the Clinical evaluation plan. The outcome of the clinical evaluation conducted in accordance with this plan is a Clinical evaluation report.
The main data analyzed in the clinical evaluation process are as follows:
• Results of clinical trials of a medical device
• Results of studies of equivalent medical devices (equivalence must be justified)
•Data published in the scientific literature regarding comparable medical devices
• The analysis and conclusions of the clinical assessment should be well structured and evidence-based.
According to MDR 2017/745, clinical evaluation of a medical device (Clinical evaluation) is a systematic and carefully planned process aimed at the continuous collection of clinical data related to the clinical use of a medical device, as well as their analysis and evaluation in order to continuously monitor the safety and effectiveness of the device.
Changes in EU legislation in the field of medical devices
On April 5, 2017, the new Regulations on Medical Devices were adopted, establishing a modernized and more robust legal framework for the European Union.
They entered into force on 25 May 2017 and will gradually replace the existing directives after a transitional period. The transition period was supposed to officially end on May 26, 2020, but the deadline was pushed back by a year due to the outbreak of the COVID-19 pandemic.
If you are a manufacturer, authorized representative, importer or distributor of medical devices in the EU, a regulatory specialist or a quality management specialist, you need to know how to comply with the provisions of the new regulation
They entered into force on 25 May 2017 and will gradually replace the existing directives after a transitional period. The transition period was supposed to officially end on May 26, 2020, but the deadline was pushed back by a year due to the outbreak of the COVID-19 pandemic.
If you are a manufacturer, authorized representative, importer or distributor of medical devices in the EU, a regulatory specialist or a quality management specialist, you need to know how to comply with the provisions of the new regulation
10 steps to comply with the provisions of the new regulation
1
Classification and determination of the purpose of a medical device
Determining the purpose of the product is the task of the manufacturer, not the consumer. Make sure your device meets the definition of a medical device and classify it according to MDR (EU) 2017/745
2
Organization of necessary processes and allocation of resources
Before you start working on a product, you need to think through the entire production chain and allocate resources. The main question needs to be answered: is your company able to attract the expertise needed to develop and obtain approval for a medical device?
3
Minimizing risks, meeting security and performance requirements
Start by planning various risk management activities. Keep in mind that risk management during development does not end with a positive risk report. The final step is to prepare a post-market surveillance plan.
4
Clinical evaluation procedure
Begin by developing a clinical evaluation plan. Whether it will include a clinical trial or a study will depend on several factors. Not only the classification of the device has an impact, but also how new the device is and the amount of clinical data on equivalent devices. The final step is the preparation of a post-marketing clinical follow-up plan.
5
Preparation of technical documentation
The information collected in the previous steps must be organized and presented in a manner that confirms that the device will meet EU specifications, achieve its intended medical purpose and be safe to use.
6
Authorised representative in the EU
For companies outside the EU, it is mandatory to appoint a legal representative in the EU who will act on behalf of the company.
Consider how your product will be distributed in the EU. Distributors have obligations, including verifying the conformity of the devices they distribute. Define communication channels with your distributors.
Determine how you will provide distributors with the necessary information and receive feedback from them.
Consider how your product will be distributed in the EU. Distributors have obligations, including verifying the conformity of the devices they distribute. Define communication channels with your distributors.
Determine how you will provide distributors with the necessary information and receive feedback from them.
7
Product and manufacturer registration
Registration consists of two parts, each of which involves uploading information to the EUDAMED database modules. Economic operators (manufacturers, authorized representatives and importers) need to register for a single registration number or "SRN". Manufacturers are required to upload information about each device, including UDI information
8
Passing a conformity assessment
Manufacturers may choose any notified body for conformity assessment, provided that the notified body has the necessary capacity to assess the type of device in question. There are special information systems with registers of authorized bodies.
9
Completion of final administrative procedures before launch
With Notified Body certifications, the manufacturer can complete the EU Declaration of Conformity and device registration.
Manufacturers that are not EU residents must provide their authorized representative with a complete package of documents (technical documentation, certificates of the notified body and confirmation of the manufacturer's registration) for the registration of the representative.
Manufacturers that are not EU residents must provide their authorized representative with a complete package of documents (technical documentation, certificates of the notified body and confirmation of the manufacturer's registration) for the registration of the representative.
10
Fulfillment of current obligations after the launch of the product on the market
Manufacturers are required to:
* Maintain a risk management system;
* Conduct planned clinical trials;
* Keep technical documentation up to date.
Manufacturers of non-standard devices must also keep additional documentation up to date..
* Maintain a risk management system;
* Conduct planned clinical trials;
* Keep technical documentation up to date.
Manufacturers of non-standard devices must also keep additional documentation up to date..