CE Marking a Medical Device under the EU MDR

What is the EU MDR

• The European Medical Device Regulation (MDR) is a set of regulations that governs the production and distribution of medical devices in Europe and Ireland.
• Compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace.

EU MDR Structure

The MDR is split into the following sections:

• Preface: 101 statements on the purpose of the legislation- (pages 1-13) 
• Chapters: 10 Chapters- these go into regulatory provisions (pages 13-92)
• Annexes: 15 Annexes- these detail and clarify requirements and provisions (pages 93-175)

Chapters

Chapter	Article	Description
Chapter I	1 - 4	Scope and definitions
Chapter II	5 - 24	Making available on the market
Chapter III	25 - 34	Identification and traceability of devices
Chapter IV	35 - 46	Notified bodies
Chapter V	51 - 60	Classification and conformity assessment
Chapter VI	61 - 82	Clinical evaluation and clinical performance
Chapter VII	83 - 95	Post market surveillance, vigilance and market suveillance
Chapter VIII	96 - 108	Cooperation between members and bodies
Chapter IX	109 - 113	Confidentiality and data protection
Chapter X	114 - 123	Final provisions

 

Annexes

Annex	Description
Annex I	General safety and performance requirements - SPR
Annex II	Technical documentation
Annex III	Technical documentation on post market surveillance -PMS
Annex IV	EU Declaration of Conformity - DoC
Annex V	CE Marking of Conformity - CE
Annex VI	Information to be Submitted - UDI+
Annex VII	Requirements to be met by Notified Bodies
Annex VIII	Classification Rules
Annex IX	Conformity Assessment - QMS and Tech Docs
Annex X	Conformity Assessment - Type Examination
Annex XI	Conformity Assessment - Production Quality Assurance
Annex XII	Certficates to be issued by a notified body
Annex XIII	Procedures for Custom Made Devices
Annex XIV	Clinical evaluation and post-market clinical follow-up
Annex XV	Clinical investigations
Annex XVI	Devices without an intended medical purpose
Annex XVII	Correlation table

 

CE Marking - 10 steps to success

1. Determine intended purpose 
2. Determine classification 
3. Determine conformity assessment routes 
4. Comply with conformity requirements 
- Quality management system 
- Technical documentation 
5. Appoint a person responsible for regulatory compliance 
6. Undertake assessment by a Notified Body 
7. Prepare and sign the Declaration of Conformity 
8. Obtain QMS and CE certificate
9. Place CE marking on device  
10. YOU’RE DONE-Undertake Post Market Surveillance and ongoing assessments 

1. Determining the intended purpose

Is you idea/research actually a medical device?
You can find this out by using the definition provided in Article 2 of the MDR:
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, which does not achieve its principal intended action by pharmacological, immunological or metabolic means.

The following products shall also be deemed to be medical devices:

• devices for the control or support of conception;
• products specifically intended for the cleaning, disinfection or sterilization of devices 
• accessories for medical devices, and products listed in Annex XVI.

2. Determine classification

Devices can be classified into the following categories:

• Class I - generally regarded as low risk 
• Class IIa - generally regarded as medium risk 
• Class IIb - generally regarded as medium/high risk 
• Class III - generally regarded as high risk 

Class I devices can be further split into three 'subclasses':

• Is - sterile device
• Im - device with a measuring function 
• Ir - is a re-usable device (i.e. surgical equipment)

Classification examples

Rule	Grouping	Example
1-4	Non Invasive Devices	Blood bags, liquid nitrogen preservation of cells and tissues of human origin, bandages
5-8	Invasive Devices	Spinal disc replacement, joint replacement, surgical meshes, stents, breast implants, examination gloves, lancets, neeldes sutures
9-13	Active Devices	Software, drill, hearing aid, muscle stimulators, surgical lasers, electrocardiographs, sensors, pumps
14-22	Special Rules	Antibiotic bone cements, heparin coated catheters, condoms, IUDs, biological heart valves, drug eluting stents, X-Ray Films

 

3. Determine conformity assessment routes

4. Comply with conformity requirements

Quality Management Systems (QMS)

• Class I devices - Only need to comply with Article 10 of the MDR for QMS requirements 
• Class Is, Im, Ir, IIa, Iib, III - We MUST have a quality management system in place, many companies comply to this standard- ISO 13485:2016- Medical devices-Quality management systems-Requirements for Regulatory purposes. 

The QMS covers the structure, responsibilities, procedures, processes and management resources required to achieve compliance with the provisions of the MDR. It is basically a big manual of how to do things and a set of procedures and processes to make sure our devices are manufactured in a consistent way. 
An ISO 13485 QMS is usually structured like the diagram below:

Technical Documents

All classification of devices require technical documents. The following Annexes in the MDR relate to technical file development:

• Annex I General Safety and Performance Requirements (SPR)
• Annex II Technical Documentation
• Annex III Technical Documentation on Post Market Surveillance
• Annex IV Declaration of Conformity

Example technical documents:
1. Device description and specification:
- Intended purpose of the device, how it works, product specification, materials, components, classification.
2. Information supplied by the manufacturer:
- Labels, promotional material, language requirements.
3. Design and manufacturing information:
- Design stages, manufacturing process, critical ingredients and suppliers, product release process, address of manufacturing sites and certificates.
4. Safety and risk management:
- Summary of risks identified, risk management plan
5. Device verification and validation:
- Summary of the results of verification and validation activities e.g. pre clinical and clinical data, clinical evaluation report, engineering tests, biocompatibility data, sterilization, electrical safety and electromagnetic compatibility, software verification and validation, post market clinical follow up plan, post market surveillance plan etc.

You may have to adhere to a range of other standard to demonstrate conformity 

5. Appoint a person responsible for regulatory compliance (PRRC-Article 15)

The appointment of person(s) responsible for regulatory compliance (PRRC) is required. They must be suitable for the role and have expertise in the field of medical devices. 

A PRRC will be responsible for carrying out/ensuring:

• Conformity of devices before release 
• Technical documentation are up to date and the Declaration of Conformity 
• Compliance with post market surveillance and vigilance requirements 

6. Undertake assessment by a Notified Body

Notified bodies provide conformity assessment services. Conformity assessments usually take the form of external audit that is split into two stages.

Examples of Notified Bodies

Body type	Name	Country
NB 0086	BSI Assurance UK Ltd	United Kingdom
NB 2797	BSI Group The Netherlands B.V.	Netherlands
NB 2409	CE Certiso Orvos - és Kórháztechnikai Ellenőrző és Tanúsító Kft	Hungary
NB 1912	DARE!! Services B.V.	Netherlands
NB 0344	DEKRA Certification B.V.	Netherlands
NB 0124	DEKRA Certification GmbH	Germany
NB 2460	DNV GL Presafe AS	Norway
NB 0051	IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.	Italy
NB 0482	MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH	Germany
NB 0050	National Standards Authority of Ireland (NSAI)	Ireland
NB 0197	TÜV Rheinland LGA Products GmbH	Germany
NB 0123	TÜV SÜD Product Service GmbH Zertifizierstellen	Germany

7. Prepare and sign the Declaration of Conformity (DoC) - Annex IV

With the declaration of conformity, the manufacturer certifies that the MDR’s general safety and performance requirements have been met by the respective medical device. Without a valid declaration of conformity, a medical device cannot be placed on the market.

It includes information such as:

• Product and trade name 
• Risk class
• Single Registration Number 

8 & 9 Obtain QMS and CE Certificate, and place CE marking on device

Image from Materials vigilance and traceability

10. YOU'RE DONE - Undertake Post Market Surveillance and ongoing assessments

Post Market Surveillance (PMS) - Annex III

You need to continue to maintain regulatory compliance.
PMS is a systematic procedure to:

• Collect and review experience gained from devices placed on the market and to identifying any necessary corrective or preventive actions – Article 2. 
• Actively and systematic gather, record and analyse relevant data on quality, performance and safety of a device throughout its entire lifetime.
• This surveillance should be based on your post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III. 

The post-market surveillance plan shall be part of the technical documentation specified in Annex II – Article 84 MDR.