Conformity assessment procedure under Regulation (EU) 2017/745

Regulation (EU) 2017/745 Council
Directive 93/42/EEC has been partially repealed and replaced by Regulation (EU) 2017/745 of the European Parliament and of the Council (EU) 2017/745, as amended, which applies from May 26, 2020; for exceptions, see Article 123 Entry into Force and Applicability,
amendment to applicability by Regulation (EU) 2020/561.

Regulation (EU) 2017/745 (MDR) applies to medical devices for human use, to clinical investigations concerning such medical devices and accessories conducted in the EU, and to the list of product groups without a specific therapeutic purpose set out in Annex XVI.

Reasons for the adoption of Regulation (EU) 2017/745 (MDR)

The application of Council Directive 93/42/EEC (MDD) revealed shortcomings and inconsistencies in the coverage of products and conformity assessment procedures, which had to be addressed by additional implementing regulations and, in particular, by the non-legally enforceable requirements of the MEDDEV and NBOG recommendations. The MDR contains detailed specifications and procedures directly within the text of Regulation (EU) 2017/745 (MDR).
The implementation of Council Directive 93/42/EEC (MDD) was not uniform across all Member States.
Council Directive 93/42/EEC (MDD) excludes devices intended solely for aesthetic or non-therapeutic purposes, even though the technology and risks to users are practically the same as for medical devices.
Council Directive 93/42/EEC (MDD) does not address the possibility of deterioration in the properties of medical devices caused by improper practices of importers and distributors. The need to ensure that users receive only compliant devices.
There is no reason to address active implantable medical devices (AIMD) under a separate regulation, as its structure and requirements are practically identical to those of the MDD.
The need to implement principles in accordance with the new legislative framework (NLF).
The MDR strengthens the traceability of medical devices (MD), ensuring a unique identification system and databases of manufacturers, products, certificates, clinical trials, etc.
The MDR simplifies the recertification process, provided that legislative regulations, harmonized standards, or the design and manufacture of medical devices do not change.
The MDR standardizes and supplements terminology, and “legalizes” established terms.
The MDR establishes the Medical Device Coordination Group (MDCG).
The European Commission is granted the authority to appoint expert groups and expert laboratories to support it in this area.
Healthcare facilities (hospitals, public health authorities, and their laboratories) have the option to manufacture, modify, and use devices internally to address the specific needs of target patient groups that cannot be met with an equivalent device available on the market at an adequate level of effectiveness. Certain provisions of the MDR should not apply to these healthcare facilities.
Informing potential patients about implantable and high-risk medical devices and their benefits, risks, and therapeutic alternatives through a summary of safety and clinical performance data.
Direct incorporation of requirements for specific products, or processes related to their manufacture and marketing, into the EU legislative system through Common Specifications instead of harmonized standards (departure from the New Approach).

Transitional Provisions:
Regulation (EU) 2017/745 (MDR) entered into force on May 26, 2017. However, most provisions of the MDR apply from May 26, 2020; for exceptions, see Article 123 Entry into force and applicability, amendment of applicability by Regulation (EU) 2020/561.
Medical devices that meet the requirements of the MDR may be placed on the market even before May 26, 2020.
On May 26, 2020, the notifications of notified bodies under Directives 90/385/EEC and 93/42/EEC cease to be valid.
Certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC:

those issued before May 25, 2017, remain valid until the end of the validity period stated on the certificate;

an exception applies to certificates issued in accordance with Annex IV (EC verification) of Directive 90/385/EEC or Annex IV (EC verification) of Directive 93/42/EEC, which expire no later than May 27, 2022.

Certificates issued after May 25, 2017, remain valid until the end of the validity period stated on the certificate, which may not exceed five years from the date of issuance. However, they expire no later than May 27, 2024.

Other certificates issued before May 26, 2020, by notified bodies pursuant to Directives 90/385/EEC and 93/42/EEC remain valid until the end of the validity period stated on the certificate, which may not exceed five years from its issuance, or until May 27, 2024, whichever occurs first. The

binding nature of EU regulations in the field of medical devices, terms, and definitions in the MDR

The Treaty of Lisbon

, the Treaty on European Union, and the Treaty on the Functioning of the European Union define the objectives, principles, and areas of integration and take precedence over other EU law and the laws of Member States.

Regulation:

direct legal effect without transposition into the legislation of Member States; a generally and directly binding legal act. A national regulation that conflicts with a regulation is valid but unenforceable. A regulation is an instrument of legal unification, and the EU uses it where a common decision is needed to achieve unity in both the content and form of the law.

A directive

has no direct legal effect. It obliges Member States to transpose it into their legislation. Only after the directive has been transposed do its requirements apply to individuals in the Member States. Directives are an instrument of harmonization of national legal systems, since once they are adopted at the EU level, individual Member States are required to incorporate them into their legal systems through domestic legislation. In terms of content, their provisions are comparable (harmonized), but they may differ in form. Different countries handle this differently (by enacting a special law or decree, or by amending several existing laws). If a Member State fails to incorporate a directive into its legal system within the deadline specified therein, the state violates Community law and may be subject to sanctions.

A decision is

an executive instrument that addresses a specific problem. It is binding only on the entities to which it is addressed. It differs from a regulation in that it does not have general applicability, and from a directive in that it does not need to be transposed into national law. It applies directly, but only to specific entities.

Judgments of the Court

are binding only on the entities to which they are addressed. In the case of interpreting applicable provisions of EU regulations, a judgment becomes a generally recognized standard (case law).

Recommendations, opinions, and resolutions

are not legally binding

unlike regulations, directives

and decisions. They provide guidance on a consolidated approach or a code of conduct.
In the EU, they sometimes precede the adoption of binding legal acts, as the Commission often first attempts to regulate a particular area through voluntary recommendations and only resorts to proposals for regulations or directives when necessary.

Acquis communautaire
Refers to the body of all legal rules in any form (both generally binding and individually binding acts) and even non-legally binding documents (declarations, statements, guidelines, recommendations, etc.) that relate to the activities of the European Union. These rules are accepted and followed in practice, even though they do not take the form of legally binding legislation (e.g., MEDDEV or NBOG documents). This is why EU authorities require compliance with the requirements of advisory documents (e.g., NBOG Recommendations), even though they are not legally binding; however, it is the European Court of Justice alone that may decide on the interpretation of legislation.

Terms and Definitions in the MDR
To properly understand the text of Regulation (EU) 2017/745 (MDR), it is necessary to thoroughly familiarize oneself with the terms listed in Article 2 of Regulation (EU) 2017/745 (MDR). Article 2 contains a total of 71 terms used in the MDR . Most terms are familiar from the use of the AIMD and MDD Directives; although they do not appear directly in those Directives, definitions outside of them can be found in MEDDEV guidelines and NBOG (Notified Bodies Operations Group) documents.

New terms in Regulation (EU) 2017/745 (MDR):
Set of devices
: a combination of products packaged together and placed on the market for use for a specific therapeutic purpose

. System: a combination of products, whether packaged
together or not, intended to be connected or combined for a specific therapeutic purpose. Intended
purpose: the use for which the device is intended according to the information provided by the manufacturer on the labeling, in the instructions for use, or in promotional or sales materials or statements, and as specified by the manufacturer in the context of a clinical

trial. Labeling: information in written, printed, or graphic form appearing either on the device itself, or on the packaging of each part or on the packaging of multiple devices
. Instructions for use
: information provided by the manufacturer that informs users about the intended purpose and proper use of the device and any precautions to be taken
. Unique Device Identifier (UDI
): a series of numeric or alphanumeric characters, created using internationally accepted identification and coding standards and enabling the unambiguous identification of specific devices on the marketEffectivenessThe

ability of a medical device to fulfill the intended purpose specified by the

manufacturerRiskThe combination of the probability of harm occurring and the severity of such
harm. Benefit-risk assessment
: an analysis of all assessments of the benefits and risks that may be associated with the use of a device for its intended purpose, provided it is used in accordance with that intended purpose
. Placing on the market:
the supply of a device (with the exception of a device that is the subject of a clinical trial) for distribution, consumption, or use on the EU market, whether for a fee or free of charge
. Placing on the market
: the first supply of a device to the EU market
. Putting into
service: the stage at which the device is provided to the end user as a device that is ready for use for its intended purpose for the first
time. Manufacturer
(natural or legal person): a person who manufactures or completely refurbishes a device, or has a device designed, manufactured, or completely refurbished, and places it on the market under their own name or trademarkAuthorized
Representative
(AR) a natural or legal person established in the EU who has received a written mandate from the manufacturer to act on their behalf in fulfilling specific tasks related to the manufacturer’s obligations under the MDRImporterA

person established in the EU who places a device from a third country on the
EU
marketDistributorA person in the supply chain, other than the manufacturer or importer, who supplies the device to the market up to the point of putting it into
serviceEconomic
operatorManufacturer, importer, distributor, and authorized representative, as well as a person who combines CE-marked medical devices into a single unit (system or kit) with other medical devices, IVDs, or other products, and a person who sterilizes such systems or kits for the purpose of placing them on the
marketConformity assessment
: a procedure demonstrating compliance with the MDR requirements applicable to a given medical
deviceCE marking
“CE marking” means the marking by which the manufacturer indicates that the device is in conformity with the relevant requirements set out in the MDR and other relevant Union harmonization legislation governing its placing on the
marketAdverse event
: an adverse change in health status, unintended illness or injury, or any adverse clinical signs, including abnormal laboratory findings, in subjects, users, or other persons in a clinical trial, whether or
not related to the
device under investigationIncident any malfunction or deterioration in the characteristics or performance of a device placed on the market, including user error due to ergonomic characteristics, as well as any deficiency in the information provided by the manufacturer and any undesirable side effect
. Serious adverse event
: an adverse event that resulted in any of the following:
- death
- serious deterioration in the subject’s health that resulted in any of the following:
i) life-threatening illness or injury;
ii) permanent physical impairment or impairment of a bodily function
; iii) hospitalization or prolongation of a patient’s hospitalization
; iv) medical or surgical intervention to prevent a life-threatening illness or injury or permanent physical impairment or impairment of a bodily
function; v
) chronic illness; - threat to the fetus, fetal death, or congenital physical or mental disability or birth defectSerious public
health threat
: an event that could result in an immediate risk of death, serious
deterioration of a person’s health, or a serious illness that may require immediate medical intervention, and which may cause significant morbidity or mortality among people, or which is unusual and unexpected
for the given place and timeSerious adverse eventan adverse
event that directly or indirectly leads, could have led, or may lead to any of the following consequences:
a) death of the patient, user, or another person
; b) temporary or permanent deterioration in the health of the patient, user, or another person
; c) serious threat to public health
. Corrective action
: a measure taken to eliminate the cause of a potential or actual nonconformity or other undesirable situation
. Safety corrective actio
n: a corrective action taken by the manufacturer for technical or medical reasons to prevent or reduce the risks of a serious adverse event in the field associated with a device placed on the market. Field
safety
notice: a communication sent by the manufacturer to users or a notice to consumers in connection with a field safety corrective action.

Classification of medical devices
: Medical devices are divided into classes I, IIa, IIb, and III based on the intended purpose of each device and the risks associated with it. The new classification rules for medical devices are detailed in Annex VIII of Regulation (EU) 2017/745 of the European Parliament and of the Council. Every medical device must undergo a classification process in accordance with these new rules. The classification rules are similar but not identical; their number has increased from 18 to 22.
The new classification rules are listed here for:

invasive and active devices,
non-invasive devices,
invasive devices

and active devices

. New essential requirements
: A medical device must meet the general safety and performance requirements applicable to it, taking into account its intended purpose. The general requirements for medical devices are set out in Annex I to Regulation (EU) 2017/745 (MDR)in the form of risk management.
Where necessary, demonstrating compliance with the general safety and performance requirements also includes a clinical evaluation in accordance with Article 61 of Regulation (EU) 2017/745 (MDR).Design and manufacturing

requirements:

Chemical, physical, and biological properties
Infection and microbial contamination
Devices containing a substance considered to be a medicinal product, and devices composed of substances or combinations of substances that are absorbed by or locally dispersed in the human body
Devices containing materials of biological origin
Device design and interaction with their environment
Devices with a diagnostic or measuring function
Protection against radiation
Electronic programmable systems – devices containing electronic programmable systems and software that is a device in itself
Active devices and devices connected to them
Specific requirements for active implantable devices
Protection against risks related to mechanical and thermal properties
Protection of the patient or user against risks posed by devices delivering energy or substances
Protection against risks posed by medical devices intended by the manufacturer for use by lay persons
Requirements regarding information provided with the device (expressed as a very detailed list for various types of medical devices)

Common specifications (Article 9, MDR)
“common specifications” means a set of technical and/or clinical requirements other than a standard, which serves as a tool for fulfilling the legal obligations applicable to a given device, procedure, or system. Where harmonized standards do not exist or where harmonized standards are insufficient, the EC may, after consulting the Medical Device Coordination Group, adopt, by means of implementing acts

common specifications for:

the general safety and performance requirements in Annex I;
the technical documentation set out in Annexes II and III;
clinical evaluation and PMCF* set out in Annex XIV;
and the requirements regarding clinical trials set out in Annex XV

*PMCF is an ongoing and updated clinical evaluation

process“common specifications” are a set of technical and/or clinical requirements other than a standard, which serve as a tool for fulfilling the legal obligations applicable to a given device, procedure, or system (Article 2(71) of the MDR)

Common specifications must be in line with the latest scientific knowledge and must apply the general safety and performance requirements set out in the MDR.

Common specifications for each product group listed in Annex XVI must address, at a minimum, the application of risk management as set out in Annex I for that product group and, where necessary, clinical evaluation regarding safety.
The necessary common specifications must be adopted by May 26, 2021; they shall apply six months after the date of their entry into force or from May 26, 2021, whichever is later.Manufacturers of medical devices
must comply with the common specifications or must justify the adoption of measures ensuring a level of safety and performance that is at least equivalent.

Reprocessing of single-use medical devices (Article 17, MDR)

If the common specifications are not adopted by May 26, 2020, reprocessing shall be carried out in accordance with the relevant harmonized standards and national regulations that apply to the requirements:
— risk management, including design and material analysis, related device characteristics (reverse engineering), and procedures for detecting changes in the design of the original device, as well as the intended use after remanufacturing,
— validation of procedures for the entire process, including individual cleaning stages,
— product release and performance testing,
— the quality management system,
— reporting of adverse events related to devices that have been reprocessed,
— traceability of reprocessed devices.

“reprocessing” means a procedure performed on a used device to enable its safe reuse; it includes cleaning, disinfection, sterilization, and related procedures, as well as testing and restoration of the technical and functional safety of the used device (Article 2(39) of the MDR)U nique Device I dentification

(UDI ) system (Article 27, Annex VI, Part C, of the MDR)

The UDI system consists of two parts:

the UDI-DI identifier, specific to a medical device model from a particular manufacturer
;

and the UDI-PI identifier, specific to a manufactured unit of a medical device

. The UDI is a series of numeric or alphanumeric characters created using a globally accepted standard for device identification and coding. It enables the unique identification of a specific device on the market. Placement

of Unique Device Identifiers (UDI) on the device labeling (Article 27, paragraph 4 of the MDR):

from May 26, 2021, for implantable devices and Class II medical devices
; from May 26, 2023, for Class IIa and IIb medical devices
; from May 26, 2026, for Class I medical devices.

Commission Implementing Decision (EU) 2019/939 designating issuing entities designated to operate the system for assigning Unique Device Identifiers (UDI) in the field of medical devices. The Annex to Decision(EU) 2019/939 designates the following organizations to operate the UDI assignment system under Regulation (EU) 2017/745 and to operate the UDI assignment system under Regulation (EU) 2017/746:

GS1 AISBL,
Health Industry Business Communications Council (HIBCC),
ICCBBA, and Informationsstelle für Arzneispezialitäten – IFA GmbH,

which already assign barcodes and other codes today for various purposes, including outside the field of medical devices.

The European Database on Medical Devices (Eudamed) (Article 33, MDR) The

European Database on Medical Devices (Eudamed) is not yet fully operational, the EC has announced a new launch date for the full version of the Eudamed database as May 26, 2022; for more information, see the May 2021 document MDCG 2021-1 Rev.1 . Until Eudamed is fully operational, entities shall follow the rules of the MDD.

European Medical Devices Database - EUDAMED is equipped with additional functions related to the UDI system, an electronic system for the registration of medical devices and economic operators, an electronic system for market surveillance, vigilance, and post-market monitoring, an electronic system for clinical trials, and an electronic system for notified bodies and certificates. Eudamed should only publish information that is not confidential.

TASKS AND FEATURES OF THE EUDAMED
DATABASE

: to inform the public about medical devices, economic operators, and certificates;
to enable unique identification and facilitate the traceability of medical devices;
to inform the public about clinical trials; and to serve as a communication tool between the competent authorities of EU Member States.

Data is entered into Eudamed by Member States (MS), notified bodies, and economic operators; the database is managed by the Commission. All information in Eudamed is accessible to Member States and the Commission. A limited scope of information is accessible to notified bodies, economic operators, sponsors, and the public. Data subjects will have the right to access data concerning them and the right to correct and delete inaccurate or incomplete data (corrections and deletions will be made as soon as possible, but no later than 60 days after the data subject submits a request).

The European database of medical devices, Eudamed, is not yet fully operational; the EC has announced a new launch date for the full version of the Eudamed database as May 26, 2022; for more information, see the May 2021 document MDCG 2021-1 Rev.1

Manufacturer’s obligations

General obligations of the manufacturer set out in Article 12 of Regulation (EU) 2017/745 of the European Parliament and of the Council.

Conformity

assessment
procedures Regulation (EU) 2017/745 (MDR) contains detailed specifications and procedures for medical device manufacturers directly within the text of the Regulation. Conformity assessment procedures are selected in accordance with Article 52 of the MDR, Annex IX Conformity assessment based on a quality management system and on the assessment of technical documentation, Annex X Conformity assessment based on type examination, and Annex XI Conformity assessment based on verification of product conformity. Additional specific conformity assessment procedures for Class III implantable medical devices and Class IIb active devices are set out in Annex IX, Section 5.1. Additional specific conformity assessment procedures for medical devices with substances intended to be introduced into the human body through a body orifice or by application to the skin and which are absorbed by the human body or locally dispersed within the human body are set out in Annex IX, Section 5.4.

Technical Documentation

The requirements for technical documentation are set out in Annex II of the MDR, and the requirements for technical documentation regarding post-market surveillance of medical devices are set out in Annex III, which the manufacturer must prepare in accordance with the requirements of Articles 83 and 86 of the MDR. The technical documentation shall be updated accordingly, and the product design shall be modified if necessary.

Distance
SellingA medical device offered via information society services within the meaning of Article 1(1)(b) of Directive (EU) 2015/1535 to a natural or legal person established in the Union must comply with the requirements of Regulation (EU) 2017/745.

Medical Device Coordination
Group (MDCG)Pursuant to the Regulation, a Medical Device Coordination Group (MDCG) has been established, consisting of representatives from individual countries. Prior to the placing on the market of, in particular, high-risk devices, this group will review the assessments conducted by notified bodies. The Commission shall lay down detailed rules for the coordination groups of notified bodies.

Additional sources of information:

National Medical Device Information System , https://www.niszp.cz/cs/legislativa

CzechMed Interest Group, Czech Association of Medical Device Suppliers, www.czechmed.cz

CzechMed, member of the European MedTech Forum,

www.medtechforum.euWebová EC Medical Devices - Sector page