Now it is the time!

The time to meet the new regulation’s standards for medical devices as it will go into effect on the 26th of May 2021.

It was supposed to be effective since May 2020, but the EMA decided to postpone it until May 2021 due to the coronavirus crisis, but it looks like it will not be postponed again, and we will have to adapt to it soon.

With this in mind, we have prepared a guide with the most important aspects to take into account.

Are you ready? Let’s start!

MEDICAL DEVICES AND CE MARK

Every medical device before being sold in Europe requires a CE mark, even if the product is imported from outside the Economic European Area (EEA).

The CE mark certifies that a medical device complies with essential requirements stipulated by the European Regulation (MDR 2017/745 and IVDR 2017/746).

And therefore, it meets the quality and safety requirements for the intended purpose, meaning that the product can be freely marketed anywhere in the Economic European Area (EEA).

Once we have a CE mark, the product can be freely marketed anywhere in the Economic European Area.

CE mark Leon Research

PROCESS TO OBTAIN THE CE MARK

The general process to obtain the CE mark in medical devices is the following:

-Manufacture the medical device guided by harmonized standards (e.g. UNE-EN-ISO 13485), so the product meets applicable essential requirements stipulated in the legislation in force.

-Confirm the correct classification of the product.

-Choose evaluation procedure to obtain CE mark.

-Prepare all the documentation to be evaluated according to the chosen procedure and organizing it following technical file sections reflected in current legislation, including quality, safety and clinical data.

-Submit the evaluation request by a Notified body.

-Evaluation by a Notified body (if needed).

-EU declaration of conformity: CE mark certification.

-Follow-up activities to maintain CE mark.

Process to obtain the ce mark

NEW REGULATION ON MEDICAL DEVICES

The new regulation of medical devices aims to stablish the path for medical device manufacturers to enter in the European market.

We have two different regulations:

MDR 2017/745: Regulation (EU) 2017/745 of 5 April 2017 on medical devices that will go into effect on the 26th May 2021.

IVDR 2017/746: Regulation (EU) 2017/746 of 5 April 2017 on in vitro diagnostic medical devices that will go into effect on the 26th of May 2022.

MDR 2017/745 amends Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repeals Council Directives 90/385/EEC and 93/42/EEC.

On the other hand, IVDR 2017/746 repeals Directive 98/79/EC and Commission Decision 2010/227/EU.

MDR2017/745

HOW TO REGISTER A MEDICAL DEVICE IN EUROPE

These are the steps to register a medical device in Europe and to obtain the certification according to the Medical Device regulation (MDR):

1.    CE MARK STRATEGIC PLAN

The first step in order to launch a medical device on the market is defining the strategy.

It is highly recommended to stablish a complete strategic plan from the beginning of the cycle of a medical device, as it will affect all the decisions taken during the process.

Experienced support for this strategic definition is essential as depending on the device and the market opportunities the pathway is different and managing mostly all options is always a great alternative.

Cycle of a medical device:

-Idea of the product: design, intended use and risk classification.

-Development of medical device manufacturing process.

-Launch and CE mark obtention.

-Post market vigilance of medical device

-Renovation of the certification (CE mark is normally valid for 5 years)

c ycle of a medical device

2.    DEFINE INTENDED USE AND PRODUCT CLASSIFICATION.

The next step is to define the intended use of the medical device and stablish the right classification.

Again, you will probably need support here, including support from the notified bodies that can be consulted before submitting the application.

Medical device classification (MDR 2017/745)

For medical devices, and according to MDR 2017/745, there are 4 risk classes (I, IIa, IIb and III) taking into account the intended purpose of the devices and their inherent risks:

Class I: low risk, non-invasive, temporary use and reusable.

Class IIa: medium risk, invasive or non-invasive for short-term use.

Class IIb: increased risk, implantable and/or invasive for long-term use.

Class III: high risk, implantable and/or highly invasive for long-term use.

Sometimes this classification can be variable due to, for example, some temporary use products can be related to measurements of vital signs and, therefore, be classified in higher risk group.

For this reason, it is very important to confirm the correct classification of your product before the beginning of the assessment procedure, as it is variable according to the type of the medical device. Rules for this classification of the device should be well known and managed.

Medical Device in vitro classification (IVDR 2017/746)

In case of IVD medical devices, which follow IVDR 2017/746, there are also 4 risk classes (A, B, C and D), which are specific for in vitro diagnostic characteristics:

Class A: low risk for patients and public health. This includes instruments, accessories, sample collection system, etc.

Class B: moderate risk for patients and/or low risk for public health. This includes, for example, blood chemistry, pregnancy test, etc.

Class C: high risk for patients and/or moderate risk for public health. This includes, for example, oncologic markers, dangerous infectious diseases, etc.

Class D: high risk for the person and public health. This includes blood security or high-risk infectious diseases.

As for medical devices, there are also rules for this classification and should be well known as IVD medical devices classification is

variable due to, some blood analysis can be classified as class C or D, depending on the type of blood marker.

For this reason, it is very important to confirm the correct classification of your product with the chosen notified body before starting the assessment procedure.

3.    QUALITY MANAGEMENT SYSTEM (QMS) AND CONFORMITY WITH ESSENTIAL REQUIREMENTS

Stablishing the Quality Management System for your medical device is one of the first things to do as it determines the quality requirements and how the product will be tested.

It is highly recommended to follow harmonized standards, for example UNE-EN-ISO 13485, which is specific for medical devices, but also all other harmonized standards that could be applicable for your specific product.

The conformity with essential requirements is linked to the quality system, because the Notify body certify the medical device complies with the regulation by performing an audit based on the quality system implemented.

4.    CONFORMITY ASSESSMENT PROCEDURE

There are several paths to obtain the CE mark depending on the medical device classification (for both types: medical devices and IVD medical devices), and the manufacturer has to select the corresponding ones according to the applicable legislation (they often have to be combined), and support may be required here, as this decision should be taken correctly from the beginning to avoid having to take steps back.

These are the different procedures:

-Total Quality Management System.

-Product Quality Management System.

-Manufacturing Quality Management System.

-Conformity CE Declaration.

-CE verification.

paths to obtain the CE mark

5.    DOSSIER-TECHNICAL DOCUMENTATION

Once the manufacturing process is established following a specific quality management system, and the manufacturer has assured their product complies with essential requirements stipulated in the legislation, the technical file has to be elaborated, including all information about device description, manufacturing process, and pre-clinical and clinical data.

To prepare the detailed information to be included in the technical file reflected in MDR/IVRD it is required to manage the regulation:

-Medical devices: annex II of Regulation (EU) 2017/745 of 5 April 2017.

-IVD Medical devices: annex II of Regulation (EU) 2017/746 of 5 April 2017.

6.    CLINICAL EVALUATION REPORT (CER)

Although the Clinical evaluation report is part of the technical documentation, we have separated it due to the importance of it.

Clinical evaluation report is the document that compiles all the clinical evaluation and its output.

It should contain all the information needed for the notified body: pertinent data and analysis of the data.

It should support demonstration of conformity with the essential requirements of the Directive.


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Main aspects to be included:

-Summary

-Scope of the clinical evaluation

-Clinical background

-Device information: type of evaluation or demonstration, clinical data generated, clinical data literature, summary, analysis

-Conclusions

The need for a clinical trial depends on the type of product and the availability of existing data.

If the manufacturer considers that there is enough bibliographic data to demonstrate the benefits and risks and comply with the essential requirement, there is no need to perform a clinical study.

clinical trials and medical devices

7.    APPLICATION EVALUATION TO A NOTIFIED BODY (IF APPLICABLE)

The application should include:

-The technical file.

-Application form.

Other requirements can change according to the notified body chosen by the applicant, so the election of the notified body is also really relevant and some guidance on this selection process can be really useful

After the submission of the application, the notified body will review the technical documentation and prepare an audit that should be really well prepared from the applicant as it will determine the approval.

As mentioned, once the notified body has finalized the review of the technical file, an audit would be scheduled. Sometimes, the review of the technical file is done during the audit, and not before. This activity depends on the internal organization of the notified body.

During the audit, the notified body will verify the compliance of all manufacturer procedures and collected information/documentation with the essential requirements reflected in the regulation of medical devices and IVD medical devices.

The audit schedule, as well as the evaluated items and part of the manufacturing process review, would depend on the conformity assessments procedure chosen by the applicant.

8.    GET APPROVAL AND CE MARK

Most devices would need the certification process to be put on the market.

However, with some class I medical devices it is valid a self-declaration of conformity.

self-declaration of conformity

The certificate of approval will generally extend for a period of validity of 5 years and may be extended for successive periods of the same duration, upon request by the company before the end of the validity period.

During those 5 years the manufacture can be audited and/or inspected by the regulatory agencies or by the Notified bodies.

The Conformitè Europëenne Mark (CE mark) is the symbol that indicates that the product has been assessed to meet high safety, health and environmental protection requirements. 

How to register a medical device in Europe

POST VIGILANCE ON YOUR MEDICAL DEVICE

After the device is CE marked, manufacturers should implant review procedures to ensure the device is safe.

Data to obtain feedback related to the design and manufacturing process should be collected and the safety of the device should be assessed. This activity can be outsourced to ensure that the vigilance and safety requirements are fully compliant with the European regulation.

Any significant change on the medical device should be informed to the notified bodies as required by regulation.

NOTIFIED BODIES AUTHORIZED FOR CE MARK CERTIFICATION

The European commission has created a public website called NANDO Information System (New Approach Notified and Designated Organization), where everyone can confirm which notified bodies are authorized for CE mark certification according to the different legal basis as Regulation (EU) 2017/745 on medical devices or Regulation (EU) 2017/746 on in vitro diagnostic medical devices.

You can check this information in here.

Although all countries have, at least, one notified body, for latest medical device regulation (MDR 2017/745 and MDR 2017/746) there are only a few amounts of notified bodies which have get the authorization for CE mark certification.

For the Regulation (EU) 2017/745 on medical devices the notified bodies for the European Countries are the following (last update: 22Feb2021):

Notified bodies for Regulation EU 2017/745
NB 2696UDEM Adriatic d.o.o.Croatia
NB 0598 (ex-0403)SGS FIMKO OYFinland
NB 0459GMEDFrance
NB 0123TÜV SÜD Product Service GmbH ZertifizierstellenGermany
NB 0124DEKRA Certification GmbHGermany
NB 0197TÜV Rheinland LGA Products GmbHGermany
NB 0297DQS Medizinprodukte GmbHGermany
NB 0482MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBHGermany
NB 0483MDC MEDICAL DEVICE CERTIFICATION GMBHGermany
NB 2409CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft.Hungary
NB 0050National Standards Authority of Ireland (NSAI)Ireland
NB 0051IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.Italy
NB 0373ISTITUTO SUPERIORE DI SANITA’Italy
NB 0344DEKRA Certification B.V.Netherlands
NB 1912DARE!! Services B.V.Netherlands
NB 2797BSI Group The Netherlands B.V.Netherlands
NB 2460DNV GL Presafe ASNorway
NB 22653EC International a.s.Slovakia
NB 2862Intertek Medical Notified Body ABSweden

For the Regulation (EU) 2017/746 on in vitro diagnostic medical devices the notify body for the European Countries are the following (Last update: 22Feb2021):

Notified bodies for Regulation EU 2017/746
NB 0123TÜV SÜD Product Service GmbH ZertifizierstellenGermany
NB 0124DEKRA Certification GmbHGermany
NB 0197
TÜV Rheinland LGA Products GmbH
Germany
NB 2797BSI Group The Netherlands B.V.Netherlands

FREQUENTLY ASKED QUESTIONS

Do medical devices require clinical trials?

It depends on the type of product as usually in high-risk devices and implants are more likely to require clinical investigation data.

An also on the availability of exiting data. The manufacturer should consider if they have enough bibliographic data to demonstrate the benefit and risks, claims and side effects to comply with the essential requirements.

Which Notify body is authorized for certificate a medical device in Europe?

The notify bodies authorized can be checked at The European commission website NANDO (New approach notified and Designated Organization)

Why there is a new medical device regulation (MDR) 2017/745 and 2017/746 on in vitro diagnostic medical devices?

The main changes of the new regulations are:

-Notified bodies designation:

  • Close follow-up by Health Authorities and European Commission.
  • Reinforcement of the obligations of the economic agents involved in the chain.

-Transparency in the EU market due to the close follow-up of importers and distribution activities.

-Implantation of Unique Device Identification (UDI).

-Authorized representative roll.

-Safety: a consistently high level of health and safety protection for EU citizens.

-Higher level of follow-up activities after the marketing authorization of the medical devices.

When does the MDR go effective?

Last Regulation (EU) 2020/561 of the European Parliament and of the Council of 23 April 2020 amending Regulation (EU) 2017/745 of medical devices, as regards the dates of application of certain of its provisions, delaying the date from 27th of May 2020 to 26th of May 2021.

For in vitro diagnostic medical devices, Regulation (EU) 2017/746 of 5 April 2017 will go into effect on the 26th of May 2022.

What are the Essential requirements for medical devices?

The essential requirements can be called also general safety and functioning requirements, and they are the characteristics to be fulfilled to comply with the intended use of the product specified by the manufacturer with the highest degree of safety and effectiveness possible.

How long is CE certificate valid?

Usually, CE mark will be valid for 5 years, and it can be extended for successive periods of the same duration, upon request of the company, 6 months before the end of validity foreseen.

In case your medical device has been authorized under MDD instead of MDR, the maximum limit for issuing CE certificates according to Directive 93/42/EC is May 26th, 2021. In the case of CE certificates issued according to Directive 98/79/EC, it will be May 25, 2022. In both cases, the maximum validity of the certificates will be until May 26, 2024


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