MDR 2017/745 A BRIEF INTRODUCTION - APRIL 2019 - QBD
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MDR 2017/745
a brief introduction
April 2019
1
Contents 1. MDR 2017/745: a brief introduction 3 1.1 The importance of compliance 4 1.2 Scope of MDR 207/745 4 2. From directive to regulation: the most important changes 4 2.1 Classification rules 4 2.2 Routes of conformity 5 2.3 Quality Management System 5 2.4 Technical documentation 6 2.5 Clinical evidence 7 2.6 Post-Market Surveillance Requirements – technical files 8 2.7 Accessory 8 2.8 Mandatory Product Liability Insurance 8 2.9 EUDAMED 8 3. Roles and responsibilities 9 3.1 Authorised representatives 9 3.2 Person responsible for regulatory compliance 9 3.3 Importers, distributors and assemblers 9 3.4 Contract manufacturers 9 4. Next steps 10 5. References 10 6. About QbD 10
1. MDR 2017/745: a brief introduction
The EU Medical Devices Regulation 2017/745, or briefly MDR, Important players and experienced medical devices
has entered into force on 25 May 2017. The adoption of the manufacturers are making significant efforts to be fully
new regulation replaces the two former directives, the Medical prepared for the transition and to recertify all their products
Devices Directive 93/42/EEC (MDD) and the Active Implantable on the market before the DoA. However, start-ups that want to
Medical Devices Directive 90/385/EEC (AIMD). In addition, the enter the market with their new products in the coming years,
adoption marks the start of a three-year transition period for are confronted with the decision whether to still file for submission
companies, since the new regulation means that the market under the MDD or file under the more stringent MDR. The timing
access framework for involved parties will change significantly. for market entry is crucial: submissions after 26 May 2020 will
Companies have the duration of the transition period to update no longer be accepted by the notified bodies under MDD.
their technical documentation and processes to meet the new The availability of quality and regulatory resources and the
requirements. strategic business plan will mostly drive the decision whether
or not to get certified before this deadline. A schematic overview
of the planning can be found below.
May 26th 2020 May 26th 2024
May 26th 2017
Date of Application Latest expiration date of all AIMDD &
Entry into force MDR
(DoA) MDR MDD certificates
Transition period 3 years
New products can be submitted New products will only be issued CE under MDR
under MDD or MDR
AIMDD & MDD certificates remain valid (max. 5 years after issuing or 4 years
after MDR DoA – whichever comes first)
H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2 H1 H2
2017 2018 2019 2020 2021 2022 2023 2024 2025
3
This whitepaper discusses the most important changes with
respect to the transition from directive to regulation. Devices with both a medically and non-medically intended
QbD believes that knowledge of these changes is a crucial use shall fulfil cumulatively the requirements applicable
foundation for an efficient transition period and, in the end, to devices with an intended medical purpose and those
successful compliance to the new regulation. In addition, we applicable to devices without (Art 10). The line between
provide an overview of the various roles and responsibilities that medical device and medicinal product is a grey area
should be part of your organization according to the new MDR. for interpretation. The principal action of the item will
To conclude, we list important next steps to further update determine whether it is a medicine or a medical device, it
technical documentation and processes in the time to come. cannot be regulated by both routes.
1.1 The importance of compliance
There are two important reasons for the adoption of the new
regulation. First of all, it addresses some weaknesses in the 2. From directive to regulation:
previous directives. Problems with various interpretations of the the most important changes
directives as well as incidents regarding fraudulent production
of certain products, had negative effects on the confidence of The changes that follow from the transition from directive to
patients, consumers and healthcare professionals when it comes regulation are comprehensive – from classification rules to
to the safety of medical devices, according to the European Post-Market Surveillance Requirements. This chapter discusses
Commission. Secondly, the technical developments regarding the most important changes for companies, including the most
medical devices are growing rapidly, and it’s crucial to modernize important action to take.
the system accordingly. According to the European Commission, the
revision ‘was necessary to consolidate the role of the EU as a global 2.1 Classification rules
leader in the sector over the long-term and to take into account all Under the MDR, the classification rules for medical devices
technological and scientific developments within the sector.’ are adapted. This can lead to a change in medical device
classification and subsequently a change in regulatory and Quality
Since the definition of a medical device is broadened, the MDR Management System (QMS) requirements. A key element of the
will affect many companies. Not only manufacturers of medical regulatory system has been the risk classification system based
devices, but also importers, distributors and assemblers will fall on human vulnerabilities. These new provisions variously apply
under the MDR. This also accounts for cosmetic solutions, for to cosmetic implants, standalone software, products without an
example. In the next section we will shortly address the scope of intended medical purpose, certain spine products and reusable
MDR. In addition, it’s important to realise that the MDR concerns Class 1 devices. The list of products that may have changed
both companies with new medical devices that go to market and classifications, includes active devices which control, monitor
existing companies with medical devices on the European market. or directly influence performance of other devices, devices with
Irrespective of what type of company you are, it’s important medicinal substances, devices incorporating nanomaterials,
to start your transition period in time. There’s a lot to do in a invasive devices (inhalation or local absorption), disinfectants and
relatively short amount of time, and timely preparation is the key sterilisers and more.
to optimally meet the new requirements.
1.2 Scope of MDR 207/745 What action should I take?
All devices covered by the MDD and AIMD are in scope of the Review for all your company’s products –
MDR, with the extension of several additional devices. whether they are classified as a medical
The following devices now also come within the definition of device or not – if the current classification
a medical device: still applies according to the new rules,
• devices with derivatives of tissues or cells of human origin that if needed with help of a notified body.
are non-viable or are rendered non-viable;
• devices for prediction and/or prognosis of diseases (diagnostic);
• devices for cleaning, disinfecting or sterilization of devices;
• devices that directly assist the medical functionality of a device
– accessories.
Common Specifications (CS) are mandatory for Annex XVI devices
and reprocessing.
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2.2 Routes of conformity
There are various ways to demonstrate your compliance with Although the regulations define four different classes of devices
European medical device regulations. However, some products ranging from low to high risk (Class I, Class IIa, Class IIb, Class III),
may have changed route of conformity, for example: the routes of conformity distinguish between nine different
• Devices which are mass produced by means of industrial groups of devices as demonstrated in the following overview.
manufacturing. These devices shall not be considered to
be custom-made devices
• Custom-made class III implantable devices What action should I take?
• Reusable surgical instrumentation Review for all your company’s products if
• Class IIb implantable devices: require product specific the correct route of conformity is followed,
certificates if needed with help of a notified body.
• Class III implantable devices and active Class IIb devices
intended to administer or remove medicines
• Class III devices under rule 21
NB
Class Is - Class Im
• Annex XI or Annex XI
NB
Annex II
Annex III Class I Class IIa
Annex IX - QMS
- Technical documentation
CE mark
- QMS: self assessment
- CE mark without NB
Annex IX - QMS
Annex IX - QMS Annex X
Class III Class IIb Annex XI
NB NB
2.3 Quality Management System The requirements for your QMS to be assessed for all existing
The MDR also includes extra requirements for your Quality CE certifications as from 26 May 2020 are:
Management System (QMS). Note that although EN ISO 13485:2016 • New requirements vigilance reporting: maximal duration
is not an absolute requirement, there will be a general expectation to report 15 days
that this standard will be used. ISO 13485:2016 was published • New requirement Post-Market Clinical Follow-up:
in March 2016, with a transition period of three years until 28 increased frequency of updates
February 2019. The standard is harmonised to allow presumption of • SOP for communication with commission/member states
conformity to the current directives or to the MDD in the future. to obtain SRN (Single Registration Number)
• Registration of economic operators including SRN
• Supplier review: efficient operation of the QMS
What action should I take? • System for Market Surveillance
Perform a gap assessment for the procedures • System for Serious Incident, Field Safety Corrective Action
within your QMS, for both MDR and and trend reports
ISO13485:2016. • System for PMS plan and report
• System for PSUR (Periodic Safety Update Report)
52.4 Technical documentation Other new technical documentation requirements are included in
Compared to the MDD and AIMD, the MDR contains more the following list:
details about the required technical file documentation for • UDI: companies need to make a reference to the basic Unique
organisations. This information is stipulated in Annexes II and III of Device Identification-Device Identifier (UDI-DI) and need to
the MDR. keep an up-to-date list containing all UDIs they have assigned
as part of their technical documentation, since the MDR
In short, in the technical documentation you should provide requires the traceability of all devices placed on the EU market.
suitable objective evidence to show that the device’s satisfy meets • Reusable surgical instruments: according to the MDR, the
the requirements detailed in Annex I of the MDR General Safety UDI should be placed on the instrument so that it’s readable
and Performance Requirements (GSPRs) (see below). For example, after each procedure that is performed to ready the device for
if you determine that specific GSPRs are not applicable to your the next use.
device, you need to provide ‘an explanation as to why [they] do • Implantable devices: technical files need to provide an
not apply’. ‘implant card’ with their devices. This implant card must
contain ‘information allowing the identification of the device’.
Under the new MDR, technical documentation must be archived • SUD: technical documentation needs to demonstrate why the
for a minimum of ten years – instead of five years under the MDD device is manufactured as a Single Use Device (SUD).
– after the last device has been placed on the market. In the case • Classification: technical documentation will require an update
of implantable devices, this minimum period is unchanged and about classification and rationales for that classification.
stays at fifteen years. • Changes: where applicable, you should give an overview of
the previous generation or generations of your device(s) and
identify and describe similar devices available on European or
international markets. Those devices will be taken into account
in the clinical evaluation and its updates in the course of post-
market activities.
• Design: you should explain the design stages and procedures
applied to your device for all classes of medical devices. Under
the MDD, this was only for Class III
• Post-Market Surveillance Plan: technical documentation now
requires a subpart, which specifically addresses your company’s
Post-Market Surveillance (PMS) activities in a plan, a Periodic
Safety Update Report (PSUR) for devices greater than Class I,
or a PMS report for devices of Class I. Also see paragraph 2.6
Post-Market Surveillance Requirements.
• GSPRs: technical documentation should contain information
to demonstrate conformity with the GSPRs. The GSPRs replace
the MDD’s essential requirements (ER). The ER 1-13 are replaced
by the GSPR 1-23. GSPR 1-9 describe the requirements for the
Since the definition of a medical device general performance of the device and risk management.
Chemical, physical and biological labelling are covered in GSPR
is broadened, the MDR will affect many 10-22 and GSPR 23 documents the information for the user.
companies. Not only manufacturers of
medical devices, but also importers,
What action should I take?
distributors and assemblers will fall Perform a gap assessment on your current
under the MDR. technical files, and pay special attention to
the PMS.
62.5 Clinical evidence Please note that:
The MDR is more specific about the need for clinical evidence • The MDR applies to clinical investigations conducted
and clinical evaluation, in proportion to the risk associated with a in the European Union concerning devices/products
given device. Reliance on the scientific literature to demonstrate which fall within the scope.
equivalence will be more tightly regulated, and clinical evaluations • Clinical investigations are required to be carried out
will be more closely aligned with clinical trials associated with as per chapter VI and notified body reviews of clinical
medicinal products. Some key issues to consider are: investigation data will check for conformity to Annex XV.
• Class III and Class IIb implants: clinical investigation is required • All ongoing clinical investigations need to fulfil to the
in some cases. minimum with the MDD and not yet with the MDR,
• Class III implants and Class IIb devices intended to remove however reporting of serious adverse event will need
or administer a medicinal substance: will be subject to an to be in accordance with the MDR.
additional European scrutiny process, including assessment of • There are gaps between the ISO14155 and the MDR!
the clinical evaluation, information for use, and Post-market Being compliant to the ISO 14155 is not enough.
Clinical Follow-up plan (PMCF).
• Class III and Class IIb active devices intended to remove or
administer a medicinal substance: manufacturers may request a
consultation from an expert panel prior to its clinical evaluation
and/or investigation. What action should I take?
Start by reviewing MDR requirements to
Are you a market authorisation holder (MAH)? identify which provisions are needed to
Then you need to provide the following documentation: ensure clinical investigation requirements are
• A clinical evaluation and development plan met for your medical devices. Note: this may
• Summary of safety and clinical performance, with annual require you to obtain additional clinical data
updates from clinical studies. Review your Standard
• For Class III and Class IIb active devices intended to remove Operating Procedures (SOPs) to check if
or administer a medicinal substance: evidence related to any all provisions for reporting serious adverse
expert consultations requested under Article 61.2 events are in place according to the MDR.
If you have any clinical evaluation reports
that haven’t been reviewed within the last
one to two years, you also need to review the
reports and ensure that they include post-
market surveillance data.
Under the new MDR, technical
documentation must be archived for a
minimum of ten years – instead of five
years under the MDD – after the last
device has been placed on the market.
72.6 Post-Market Surveillance Requirements –
technical files What action should I take?
Post-Market Surveillance Requirements (PMS), market Make sure to classify whether articles are
surveillance, vigilance and registration of economic operators an accessory or not, then qualify every
shall be applicable to all devices placed on the market or put into accessory as part of a medical device and the
service from the date of application, namely 26 May 2020. medical device as a whole.
This includes:
• PMS plan (Article 84) – technical file – all classes
• PMS report (Article 85) – technical file Class I devices 2.8 Mandatory Product Liability Insurance
• PSUR (Article 86) – technical file for all devices higher than Class I Manufacturers must be able to provide sufficient financial
• Serious incident, Field Safety Corrective Action (Article 87) – coverage for their potential liability. This
timeframe changed from thirty to fifteen days provision will be based on risk class, type of device and the size of
• Trend report (Article 88) the enterprise.
• Market surveillance (Article 93)
• Registration of economic operators including SRN (Article 31)
• Update of MDR requirement versus MedDev 2.12-1 (vigilance What action should I take?
guidance): maximum duration to report of fifteen days Review Product Liability provisions under
• Update of MDR requirement versus MedDev 2.12-2 (post- advice from legal counsel.
market clinical follow-up): increased frequency of updates
• SOP for communication with commission/member states to
obtain SRN 2.9 EUDAMED
• SOP to provide PSUR at correct frequency (Article 86) One of the guiding principles in the MDR preamble, is
• EU Authorised Representative: written mandate (Article 11), transparency and adequate access to information for the
SRN (Article 11), PRRC (Article 15), QMS (Article 8) intended user. According to the preamble, this is essential in the
• Importers: SRN (Article 31), QMS (Article 13) public interest, to protect public health, empower patients and
• Distributors: QMS (Article 14) healthcare professionals and enable them to make informed
decisions, to provide a sound basis for regulatory decision-
making and to build confidence in the regulatory system.
What action should I take?
Review your Standard Operating Procedures The result is a European Data Bank on Medical Devices
(SOPs) for Post-Market Surveillance (EUDAMED), which will also be made public for certain devices.
Requirements (PMS) and ensure that the Companies will need to notify all products to EUDAMED
responsibility for the provision of additional database, the obligations start from the date of application. This
data and associated support is clear. includes: clinical investigations, UDI database, notified body and
certificates, devices and modifications, economic operators,
vigilance and PMS and market surveillance.
2.7 Accessory
If we are talking about an accessory for a medical device, this
means an article which – whilst not being a medical device itself What action should I take?
– is intended by its manufacturer to be used together with one or Check if all required information is present in
several particular medical device(s). The accessory is then used to EUDAMED.
specifically enable the medical device(s) to be used in accordance
with its/their intended purpose(s) or to specifically and directly
assist the medical functionality of the medical device(s) in terms
of its/their intended purpose(s).
83. Roles and responsibilities 3.2 P
erson responsible for regulatory
compliance
The implementation of the MDR has consequences for both roles Article 15 of the MDR requires authorised representatives
within your organisation and third party roles. It’s important to to appoint at least one person responsible for regulatory
determine if all the required roles are appointed, and if this is compliance, this person also needs to be registered in the
documented in the required job descriptions, quality agreements European database. That person possesses the necessary
and Standard Operating Procedures. The most important job expertise in the field of medical devices and is responsible
profiles that have something to do with the MDR, are: for regulatory compliance. He or she also ensures that the
technical documentation is compiled and maintained.
3.1 Authorised representatives
Article 11 of the MDR states that ‘where the manufacturer of a Responsibilities are inclusive of, but not limited to: the
device is not established in a Member State, the device may only quality management system (QMS), conformity of technical
be placed on the Union market if the manufacturer designates documentation, regulatory documentation, post-market
a sole authorised representative’. Organisations from outside surveillance and vigilance reporting obligations, statement
the European Union or European Economic Area (EEA) need to of investigational devices (clinical).
enable their legal representative to keep available amongst other
documents, a copy of the technical documentation. This way they 3.3 Importers, distributors and assemblers
ensure the effectiveness of their communication with and their Under the MDR, importers and distributors are also integrated
obligations towards Competent Authorities (CAs) and Notified into the regulatory compliance paradigm as economic
Bodies (NBs). operators with specific regulatory compliance responsibilities.
This encourages companies to rethink their liaison with these
Responsibilities: to ‘verify that the EU declaration of conformity parties. Therefore it can be useful to train importers and
and technical documentation have been drawn up and, where distributors and potentially adapt processes within your
applicable, that an appropriate conformity assessment procedure Quality Management System.
has been carried out by the manufacturer’ (Article 11, 3(a)).
3.4 Contract manufacturers
If contract manufacturers intend to take legal manufacturer
responsibility for the devices that they provide to market,
they must comply with the entire MDR regulation. If contract
manufacturers don’t take legal manufacturer responsibility,
the only implication is that they may be subject to audits on
behalf of the legal manufacturers they provide services to.
This includes unannounced audits.
One of the guiding principles in the
MDR preamble, is transparency and
adequate access to information for the
intended user.
94. Next steps 5. References
The new MDR brings us various significant improvements of the • https://ec.europa.eu/growth/sectors/medical-devices/
previous directives, including improved transparency, better Post- regulatory-framework_en
Market Surveillance requirements and stricter control of high-risk • https://ec.europa.eu/growth/sectors/medical-devices/new-
devices. According to the European Commission, this will ensure regulations/guidance_en
a high level of health and safety protection for European Union • www.imdrf.org/
citizens that make use of the products and free and fair trade of • www.fda.gov/MedicalDevices/default.htm
products in the European Union.
To optimally anticipate the new regulation that starts in the 6. About QbD
spring of 2020, it’s important for companies to already start their
transition. This whitepaper provides a thorough base for the most Few sectors are exposed to risk more than the medical devices,
important changes under the new MDR. However, there are more life sciences, healthcare and cosmetics industries. Research and
steps to take. A brief step-by-step plan for your transition period Development is time consuming and expensive and bringing
includes at least the following steps: new products onto the market is subject to very strict rules.
Quality by Design (QbD) helps companies reinforce their immune
Creation of a transition plan system, guarantee full compliance, keep control of quality risks
1. Identifying the relevant differences for your company, and increase the profitability of their business. This results in
based on this whitepaper robust processes and audit-resistant systems. And thanks to their
2. Investing in risk class determination, based on the new risk-based approach focused on high-risk areas, QbD increases
classification rules and products that may have changed efficiency, reduces workload and total compliance costs while
classification. guaranteeing optimal quality, safety and compliance of products.
3. Reviewing the conformity assessment procedures for With more than 175 quality experts, QbD is your partner for advice
your company’s products, together with an authorised and support on controlling quality risks.
representative.
Read more
Creation of an implementation plan
1. Upgrading your technical files according to Annexes II and III
of the MDR
2. Performing gap assessments for your Quality Management
System, for both the MDR and ISO 13485:2016, which will
become operative as from 28 February 2019
3. Expanding your technical documentation with Post-Market
Surveillance activities and reporting
Quality by Design NV / Fotografielaan 5, 2610 Wilrijk, Belgium / T +32 3 844 45 01 / info@qbd.eu
QbD is also active in the Netherlands, France, Spain, Mexico and Colombia
Visit www.qbd.eu for more information
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