The assessment of the conformity of a medical device for CE marking (Conformité Européenne, or European Conformity)
varies according to the risk class for both MDs. Apart from the risk classification, certain features may influence
the conformity assessment procedure, for example when an MD is required to be sterile.
For MDs, all Class IIa, IIb and III devices, as well as some specific Class I devices, require the intervention of a
Notified Body (MDR Article 52 (7)(a6, b7, c8). MDR Article 52 and MDR Annexes IX, X and XI describe the different
assessment routes according to the class of the device. In some cases manufacturers can choose their conformity
assessment route from several options described in the Regulation.
There is a new clinical evaluation consultation procedure for Class III implantable devices and certain Class IIb
devices, to be carried out by an independent expert panel. The Notified Body will have to take into
consideration the scientific opinion expressed by the expert panel (MDR Article 54).
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending
Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives
90/385/EEC and 93/42/EEC.
This Regulation aims to ensure the smooth functioning of the internal market as regards medical devices, taking as
a base a high level of protection of health for patients and users, and taking into account the small- and
medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards
of quality and safety for medical devices in order to meet common safety concerns as regards such products.
Both objectives are being pursued simultaneously and are inseparably linked whilst one not being secondary to the
other. As regards Article 114 of the Treaty on the Functioning of the European Union (TFEU), this Regulation
harmonises the rules for the placing on the market and putting into service of medical devices and their
accessories on the Union market thus allowing them to benefit from the principle of free movement of goods.
As regards Article 168(4)(c) TFEU, this Regulation sets high standards of quality and safety for medical
devices by ensuring, among other things, that data generated in clinical investigations are reliable and
robust and that the safety of the subjects participating in a clinical investigation is protected.
Click here to reach MDR full text
In general, the MDR retains all the requirements of the Directive, while adding some new requirements of its own.
Compared to the current Directive, the new Regulation emphasises a life-cycle approach to safety, backed up by clinical data.
The Regulation adds more stringent rules for the designation of Notified Bodies. For national competent authorities
and the Commission, they add more control and monitoring requirements. The Regulation clarifies the obligations of
manufacturers, authorised representatives, importers and distributors.
The MDR reclassifies certain devices and has a wider scope than the Directives. It introduces an additional
pre-market consultation procedure for certain high-risk medical devices.
The Regulation increases transparency, requiring the publication of information on devices and on clinical
and performance studies related to their conformity. The new European Database for Medical Devices –
EUDAMED – will play a central role in making data available and increasing both the quantity and
quality of data (MDR Article 33)..
Yes, certificates will generally remain valid until the end of the period indicated on the certificate, or until 26 May 2024, whichever is the earlier. On 27 May 2024, certificates issued under the Directives will become void.
Yes, under certain conditions there will be an option to continue placing on the market/putting into service devices that comply with the Directives, until their existing certificates expire. This may avoid the immediate need for a new certificate under the Regulations. To use this option, all the existing certificates will have to be valid (including, for example, the QMS), the purpose and nature of the device must not change, and manufacturers must apply the new requirements with regard to registration, surveillance and vigilance.
The “sell-off” provision is intended to limit the time during which devices that are compliant with the Directives and have already been placed on the market may be made available. Any devices that are still within the supply chain and that have not reached their final user as being ready for use, for example a hospital, on 26 May 2025 are no longer marketable and must be withdrawn. Once a Directive-compliant device has been made available to the final user by the deadline, the further making available of this device is not subject to the Regulations.
Devices falling under the Medical Device Regulation (MDR) are any instrument, apparatus, appliance, software,
implant, reagent, material or other article intended by the manufacturer to be used, alone or in
Combination, for human beings for one or more of the following specific medical purposes:
Diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
Diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
Providing information by means of in-vitro examination of specimens derived from the human body, including organ, blood and tissue donations.
And which does not achieve its principal intended action by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
The following products shall also be considered as medical devices:
Devices for the control or support of conception;
Products specifically intended for the cleaning, disinfection or sterilization of devices.
Some aesthetic devices are now falling under the scope of the Medical Device Regulation (MDR).
Accessories of medical devices shall be considered as medical devices.
Devices with both a medical and a non-medical intended purpose shall fulfill cumulatively the requirements.
In addition, Annex XVI mandates that the following groups of products comply with the requirements of the MDR:
Contact lenses and other products used in or on the eye (eye drops and cosmetic contact lenses would be included here)
Products introduced into the body via surgically invasive means to modify the anatomy (silicon breast implants would now qualify here)
Products and substances used for facial or other subcutaneous fillings
Equipment used for liposuction, lipolysis, or lipoplasty
High-intensity radiation equipment used for tattoo and hair removal
Equipment using electrical or magnetic currents to stimulate the brain
Annex XVI tightens a lot of gaps that existed in the previous MDD regulations, specifically enforce
itself on devices used in procedures that escaped regulation because they were cosmetic and not
medical in nature.
Click For Annex XVI
Accessories
Accessories are products that are intended to enable a device to be used in accordance with its
intended purpose or to assist the medical functionality of the medical device. They are covered in
the scope of the Regulation, similar to the requirements in the Directives. As some products are
now added to the definition of a medical device, their accessories will also be covered by the
scope of the Regulation. Therefore it is necessary to verify all products used together with
these new categories of medical devices to identify accessories as defined in the MDR.
Some examples:
Nets for sterilization;
Devices used to position or remove invasive or implantable contraceptives;
Software used for creating images of the expected effects of breast implants
Border Line Devices
The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device
Coordination Group (MDGC), which is an advisory body of the European Commission (EC) in the
sphere of medical devices, has published a manual on borderline and classification for medical
devices under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on
in vitro diagnostic medical devices (IVDR). Guidance documents issued by the MDCG are as below:
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2
MDCG 2022-05 Guidance on borderline between medical devices and medicinal productsunder Regulation (EU) 2017/745 on medical devices
a) in vitro diagnostic medical devices covered by Regulation (EU) 2017/746;
b) medicinal products as defined in point 2 of Article 1 of Directive 2001/83/EC. In deciding whether a product
falls under Directive 2001/83/EC or under this Regulation, particular account shall be taken of the principal mode of action of the product;
c) advanced therapy medicinal products covered by Regulation (EC) No 1394/2007;
d) human blood, blood products, plasma or blood cells of human origin or devices which incorporate, when placed on
the market or put into service, such blood products, plasma or cells, except for devices referred to in paragraph 8 of this Article;
e) cosmetic products covered by Regulation (EC) No 1223/2009;
f) transplants, tissues or cells of animal origin, or their derivatives, or products containing or consisting of them;
however this Regulation does apply to devices manufactured utilising tissues or cells of animal origin, or their derivatives,
which are non-viable or are rendered non-viable;
g) transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products
containing or consisting of them; however this Regulation does apply to devices manufactured utilising derivatives of
tissues or cells of human origin which are non-viable or are rendered non-viable;
h) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material
or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
i) products, other than those referred to in points (d), (f) and (g), that contain or consist of viable biological material
or viable organisms, including living micro-organisms, bacteria, fungi or viruses in order to achieve or support the intended purpose of the product;
The definition of common specifications according to the EU MDR and IVDR is “ set of technical and/or clinical
requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system”.
The concept of common specifications is explained in the Article IX of EU MDR:
[….], where no harmonised standards exist or where relevant harmonised standards are not sufficient, or where there is a need to
address public health concerns, the Commission, after having consulted the MDCG (Medical Device Coordination Group), may, by means
of implementing acts, adopt common specifications (CS) in respect of the general safety and performance requirements set out in Annex
I, the technical documentation set out in Annexes II and III, the clinical evaluation and post-market clinical follow-up set out in
Annex XIV or the requirements regarding clinical investigation set out in Annex XV.
The first common specifications to be established by the commission were the ones for the reprocessing of single-use medical
devices.
To learn more, pls click here
Kindly see Article 10 in the MDR.
‘Authorised Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under MDR. Responsibilities of AR are explained in article 11 of the MDR.
The detailed arrangements for a change of authorised representative shall be clearly defined in an agreement between the manufacturer, where practicable the outgoing authorised representative, and the incoming authorised representative. Pls see MDR article 12 for the requirements of that agreement.
The Regulation also describes the roles and responsibilities of importers. An importer is defined as any natural or legal person established in the EU that places a device from a third country on the EU market. MDR Article 13 describes many of the general obligations of importers.
A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting it into service. The Regulation describes the roles and responsibilities of distributors, who should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR Article 14.
As per MDR Article 15, Manufacturers shall have available within their organisation at least one person responsible for regulatory
compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise
shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course
of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant
scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management
systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the
requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are
manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10);
(d) the reporting obligations referred to in Articles 87 to 91 are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
For detailed information on clarification of article 15, kindly see ;
MDCG 2019-7 Guidance on Article 15 of the Medical Device Regulation (MDR) and in vitro Diagnostic Device Regulation (IVDR) regarding
a ‘person responsible for regulatory compliance’ (PRRC).
No. Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC
shall not be required to have the person responsible for regulatory compliance within
their organisation but shall have such person permanently and continuously at their disposal.
Click For Commission Recommendation 2003/361/EC
Reprocessing and further use of single-use devices may only take place where permitted by national law and
only in accordance with MDR Article 17.
EU countries may decide not to apply all the manufacturers obligations laid down in the MDR to single-use devices that are reprocessed and used within a health institution.
If that is the case, a health institution reprocessing and reusing single-use devices should ensure that:
Safety and performance of the reprocessed device is equivalent to that of the original device,
Reprocessing is performed in accordance with common specifications Commission Implementing Regulation (EU) 2020/1207
detailing requirements concerning risk management, validation of procedures for the entire process, product release and
performance testing, quality management system, reporting of incidents and traceability.
Rules on reprocessing of single-use devices
Commission Implementing Regulation (EU) 2020/1207
The implant card must clearly identify the device and provide any relevant additional information:
Device name;
Serial number or lot or batch number;
Unique device identification (UDI) in human and machine readable format;
Name, address and the website of manufacturer;
Website of the manufacturer;
Device type.
In addition, the patient and the healthcare provider must be identified on the implant card:
Name of the patient or patient ID;
Name and address of the healthcare institution which performed the implantation;
Date of implantation.
Symbols are allowed to convey this data. Some new symbols are introduced:
Patient name or patient ID
Date of implantation
Name and address of the implanting healthcare institution/provider
Information website for patients
Device Name
What an implant card should contain is explained in the guidance document MDCG 2019-18.
This document provides guidance for Member States, concerned industry and other stakeholders on a blueprint of an implant card (IC)
required by the MDR (Regulation (EU) 2017/745). It describes the intended use, content and information to be provided by the manufacturer
together on the IC and a definition of fields to be completed by the implanting healthcare institutions or healthcare providers according
to national law in Member States.
Whereas the intended purpose and most of the data elements of the IC are already defined in Article 18 of the MDR, this document contains
the description of other data elements which must be completed by the healthcare institution or healthcare provider and which must be
considered by the individual Member State when implementing Article 18 MDR as required.
In accordance with the instructions laid out in MDCG 2021-11, the implant card should also indicate a ‘device type’ for the implantable
medical device in question.
MDCG 2021-11
MDCG 2019-18
As per Article 19 in MDR, The EU declaration of conformity shall state that the requirements specified in this Regulation
have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration
of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall
be translated into an official Union language or languages required by the Member State(s) in which the device is made available.
The EU declaration of conformity shall contain all of the following information according to Annex IV:
1. Name, registered trade name or registered trade mark and, if already issued, SRN as referred to in MDR Article 31
of the manufacturer, and, if applicable, its authorised representative, and the address of their registered place of
business where they can be contacted and their location be established;
2. A statement that the EU declaration of conformity is issued under the sole responsibility of the manufacturer;
3. The Basic UDI-DI as referred to in Part C of Annex VI;
4. Product and trade name, product code, catalogue number or other unambiguous reference allowing identification
and traceability of the device covered by the EU declaration of conformity, such as a photograph, where appropriate,
as well as its intended purpose. Except for the product or trade name, the information allowing identification and
traceability may be provided by the Basic UDI-DI referred to in point 3;
5. Risk class of the device in accordance with the rules set out in Annex VIII;
6. A statement that the device that is covered by the present declaration is in conformity with this Regulation and,
if applicable, with any other relevant Union legislation that provides for the issuing of an EU declaration of conformity;
7. References to any CS used and in relation to which conformity is declared;
8. Where applicable, the name and identification number of the notified body, a description of the conformity assessment
procedure performed and identification of the certificate or certificates issued; 9. Where applicable, additional information;
10. Place and date of issue of the declaration, name and function of the person who signed it as well
as an indication for, and on behalf of whom, that person signed, signature.
Devices, other than custom-made or investigational devices, considered to be in conformity with the requirements
of this Regulation shall bear the CE marking of conformity, as presented in Annex V.
1. The CE marking shall consist of the initials ‘CE’ taking the following form:
2. If the CE marking is reduced or enlarged, the proportions given in the above graduated drawing shall be respected.
3. The various components of the CE marking shall have substantially the same vertical dimension, which may not be less than
5. mm. This minimum dimension may be waived for small-scale devices.
4. The CE marking shall be affixed visibly, legibly and indelibly to the device or its sterile packaging. Where such
affixing is not possible or not warranted on account of the nature of the device, the CE marking shall be affixed to
the packaging. The CE marking shall also appear in any instructions for use and on any sales packaging.
5. Where applicable, the CE marking shall be followed by the identification number of the notified body responsible for
the conformity assessment procedures set out in Article 52. The identification number shall also be indicated in any
promotional material which mentions that a device fulfils the requirements for CE marking.
MDR Article 2 ( 11 ) defines a system as a combination of products, either packaged together or not, which are
intended to be inter-connected or combined to achieve a specific medical purpose ( MDR Article 2 (1)) ; whereas
a procedure pack means a combination of products packaged together and placed on the market with the purpose
of being used for a specific medical purpose (MDR Article 2(10)).
In MDR Article 22, detailed information is given on requirements of systems and procedure packs.
The MDR enables in Article 22(1) that a system or procedure pack may contain a CE-marked IVD device and/or other
devices bearing the CE marking whereas Article 12 of the MDD only accounts for the combination of devices.
According to MDD Article 1(1), devices are either medical devices or accessories, and thus IVD devices and
other devices are excluded from inclusion in a system or procedure pack under the MDD.