HomeNewsRegulation (EU) 2017/745 on medical devices

Regulation (EU) 2017/745 on medical devices

05/06/2019

 

APPLICATION OF THE NEW REGULATION (EU) 2017/745 ON MEDICAL DEVICES  

Medtech on a European scale is entering an important period in its history. Indeed, the European Directive will give way in 1 year to the regulation (EU) 2017/745 on medical devices. Entered into force on 26 May 2017 after lengthy negotiations, the Regulation will be applied from 26 May 2020. This transition period has allowed manufacturers and notified bodies to prepare for these new regulations.... Indeed, the objective of Regulation (EU) 2017/745 is to improve the traceability and transparency of medical devices on the European market, but also to be able to monitor notified bodies more closely.
 

WHAT ARE THE MAJOR CHANGES BROUGHT ABOUT BY THE NEW REGULATIONS?

Regulation (EU) 2017/745 replaces Directive 93/42/EEC on medical devices (MD) and Directive 90/385/EEC on active implantable medical devices (AIMD). In addition, the new regulation clarifies software and its classification: it qualifies as a medical device when manufacturers intend it to be used for one or more medical purposes.
 
The scope of the Regulation is extended to include devices for cosmetic and other non-medical purposes that are similar to medical devices in terms of function and risk profile, including:
  • Contact lenses
  • Liposuction, lipolysis or lipoplasty devices
  • Equipment emitting high intensity electromagnetic radiation, such as lasers for skin resurfacing, tattooing or depilation
  • Etc.
Other major changes are still to be highlighted:
 

1. Manufacturers, Agents, Distributors, Importers; all concerned by the new regulation on medical devices

Several economic actors in the Medtech sector are concerned by the arrival of this new regulation, although manufacturers and representatives were already present in Directive 93/42/EEC, their requirements have been strengthened. [...] Distributors and importers have also entered into this new regulation on medical devices.
 
Another obligation for manufacturers and agents is the appointment of a regulatory manager ensuring compliance with product conformity, updating technical documentation, conducting post-market surveillance and material vigilance. Like the pharmacists in charge, this also makes it possible to designate a privileged contact with the competent authorities.
 
This person responsible for ensuring compliance with the regulations must have one of the following qualifications:
a) A diploma, certificate or other formal certification document attesting university studies in law, medicine, pharmacy, engineering or another relevant scientific discipline, or a course cycle recognised as equivalent by the Member State concerned, and at least one year's professional experience in the field of regulation or quality management systems related to medical devices
b) Four years' professional experience in the field of regulation or quality management systems related to medical devices.
For manufacturers with less than 50 employees and agents with an annual turnover of less than €10 million, the procedure may be outsourced.
Distributors and importers will have an obligation to verify pre-market compliance with general performance and safety requirements.
 
NEOMED Services has detailed the obligations of distributors in a previous article. Also, you will find all these obligations for each operator in our Q&A.
 

2. INCREASED TRACEABILITY OF MEDICAL DEVICES (EUDAMED)

The unique device identifier (UDI) will require manufacturers to affix a unique numeric code or alpha numeric identifier to all their medical devices (except custom-made DMs). This system will be integrated into a European database called EUDAMED. This will make it possible to provide assurance on the origin of the devices but also to integrate a notion of security thanks to an identification system.
 
 
 
The IUD-ID [device model specific code] and IUD-IP [production unit identification code] codes will allow all medical devices to be tracked. This system will improve the traceability and security of DMs, in particular by making it possible to combat counterfeiting effectively. As such, any IUD will have to be registered in the database EUDAMED.
 
Our design office has detailed you in computer graphics the latest news on the European database EUDAMED..
 

3. Increased clinical requirements

NEOMED Services teams have already noticed a change in the notified bodies, which are increasingly uncompromising in terms of the quality and quantity of clinical data collected.
 
New obligations have been introduced in the new Regulation on the use of equivalence with a product competitor to perform the clinical evaluation. For medical devices implantable and class III, clinical investigations should be performed carried out. Equivalence may nevertheless be applied if both manufacturers have concluded an agreement allowing full and permanent access to documents techniques necessary to achieve equivalence, which may lead to severely limit the use of equivalence for evaluations clinical. Equivalence may also be used within the same group or the same manufacturer for range upgrades, for example.
 
Under the new regulation, conformity assessments will require more qualitative evidence and clinical data to demonstrate the performance and safety of a device, the assessment of adverse side effects and the acceptability of the benefit-risk ratio. As a general rule, clinical data on implantable devices and Class III devices should come from clinical studies that have been conducted by the manufacturer.
 
New documents will be requested. The SSCP Summary of Safety and Clinical Performance for implantable and class III medical devices, and PSUR (Periodic Security Activity Report) which shall be designed for class IIa and higher devicesThis SSCP makes it possible in particular to fight against the lack of transparency since it will be published on the EUDAMED platform to the public. The PSUR will provide a synthesis of the results and conclusions of the analysis of post-market surveillance data. Its purpose will be to indicate that the risk-benefit ratio is always positive in the post market.
 
This report will be updated as follows:
  • IIa : as required, at least every 2 years
  • IIb : at least once a year
  • III : at least once a year
  •  

    4. A revised classification

    The current rules on the classification of devices will also change, requiring stricter evaluation procedures in many areas. In particular:
     
  • Addition of a class for reusable surgical instruments Class Ir
    • Rule 8Some types of implants are classified as Class III (such as surgical mesh)
    • Rule 11: specific rule for the classification of software
    • Rule19: specific rule for medical devices incorporating nanomaterials
    • Rule21 : rule concerning substances entering the body through a natural orifice or through the skin
    • Rule22rule concerning active therapeutic devices with an integrated diagnostic function
    Our engineering office has detailed them for you in anarticle but also onvideo.
     

    5. Additional control procedures... the scrutiny process

    Scrutiny process consists of an evaluation of the technical documentation by an expert committee of the European Commission (by sampling or not depending on the class of the device) and a study of the quality of the clinical data of these products.
     
    Specific to the devices of class III implantable and active class IIb intended to administer or remove medicinal products, this procedure will not be carried out for the renewal of a certificate, the modification of a device by the same manufacturer or the existence of common specifications.
     
    A clinical data analysis report prepared by the NB and the manufacturer's documentation will be submitted to an expert committee of the European Commission (MDCG) with 21 days to inform the notified body via EUDAMED of its intention to provide a scientific opinion or not. The maximum response time is 60 days. After this period, the notified body may start the certification procedure.
     
     
     
    In the event that the notified body does not follow the opinion of the committee of experts, it must justify this in the conformity assessment report. The Committee's opinion will also have to be made available to the public in EUDAMED. Find all the information on the scrutiny process below:
    A procedure of the new Medical Devices Regulation.
     

    What regulatory and clinical strategy should be adopted?

    It is important to consider the approach of the new regulation on medical devices on many subjects... including regulatory and clinical strategies to be adopted.
     
    Is my product a DM? Which economic operator am I (distributor, importer, assembler, agent, manufacturer)? What is the classification of my device? Does the classification of my DM change with the regulations? All these questions will ultimately determine your responsibilities, those of your subcontractors and the requirements for your device.
     
    From clinical point of view, the new regulation increases the quality requirements and the amount of data collected.
    Clinical evaluation remains a systematic, planned and ongoing requirement.
    It is therefore essential to define your pre-market clinical strategy and to anticipate the post-market strategy. Thus, it will be necessary to consider what type of data is to be generated? How? On which sample?
     
      
    For manufacturers whose devices are CE marked under the Directive, it will be important to take into consideration that any substantial changes will create an obligation to comply under the new Regulation from May 2020.
     
    Finally, NEOMED Services invites you to take advantage of this transition period to strengthen the clinical data collection of your devices through post-marketing studies (PMCF) for example to strengthen your clinical evaluations.
    In this context, we offer you in partnership with Soladis Group one formation in order to raise awareness among teams in charge of activities involving clinical evaluation and clinical studies (CE marking, PMCF...) of medical devices about the impact of new regulations (MDR 2017/745, ISO 14155, MEDDEV 2.7/1 rev4).
     

    Regulation is coming ... situation of notified bodies?

     
    With less than a year to go before the application of the new Medical Devices Regulation (EU) 2017/745, there are two notified bodies certified under the new Medical Devices Regulation (BSI and TÜV).
    Other notified bodies are in the process of being notified. Data on progress in the appointment process show that 35% of Team-NB members (an association of 26 NBs) had already been audited, 24% had an audit date planned for autumn 2019, and 6% had received an invitation from their competent authority to complete their application.
     
    We invit you to contact your notified body to learn more about their designation process.
     
    Recently, two corrections have been published to clarify many incorrect or unincluded elements.
    The ANSM also indicated that the Commission was preparing a new corrigendum to extend the transitional measures to Class I DMs that require the use of a notified body (NB) or Class I DMs that change classes under the new Regulation, in order to avoid overloading notified bodies. It remains to be seen whether this measure will be accepted and within what time frame?
     
    Regulation (EU) 2017/745 on medical devices will be applied from May 2020, even if the certificates of conformity issued under Directive 93/42/EC will continue to be valid until the deadline indicated on the certificate.
    Currently, the implementation schedule of the Regulation is as follows: 
     
     
     
    Find the latest detailed information on the transitional provisions and exceptional renewals certificate under the directive on the NEOMED website.
     
    Our design office has highlighted the main new features of this EU regulation 2017/745 on medical devices. As a reminder, it is essential to generate quality data as this new regulation approaches.
    NEOMED Services accompanies you in this final straight line by keeping as close as possible to the latest information concerning you. Do not hesitate to contact us if you would like more information on the impact of this new regulation on your medical devices.
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