Certification and registration Medical devices on the European market - ttopstart spottlight

October 2013

Certification and registration Medical devices on the European market

Certification and registration Medical devices on the European market 3

Certification and registration Certification and registration Medical devices on the European market

Certification and registration Medical devices on the European market4 ttopstart

This publication provides an overview of the regulations and legislations with regard to commercialisation of medical devices. The product category of medical devices includes in vitro diagnostics (IVDs), active implantable medi-cal devices (AIMDs) as well as medical software. In Europe, market approval for medical devices is achieved via a decentralised procedure of CE marking, whereby quality and safety is addressed, and registration of the product. This procedure is in compliance with European regulations and with national legislation of the countries in which market entry is planned. In the US, market approval is granted by the FDA upon assessment of quality, safety and effectiveness. Though complex, the decentralised European system seems to speed up the access to medical devices at least three years as compared to the central system in the US or systems elsewhere in the world.

The information provided here informs start-ups, spin-offs and biotech companies about the differences in regulative procedures for specific classes of medical devices and between the authorities and regulations in Europe and the US. By summarising the build-up of a technical file, the significance of a quality management system (QMS), the selection of Annexes, the advan-tages of adherence to ISO standards, the use of MEDDEV guidelines and the procedures for standalone software and IVDs specifically, we aim to offer a guide through dense regulative and legislative landscape. These insights can be used to design the optimal market introduction strategy for your medical device.

Executive summary


Contents

Scope European legislation on medical devices

Medical devices Medical software

In vitro diagnostic medical devices Active implantable medical devices

CE certification Notified Bodies Preliminary procedure CE certification procedure QMS Technical fileInvestmentFollow-up and extension

RegistrationEudamedNOTISRegistration and market approval in Europe versus USImporting US products into Europe Exporting EU products into the US

ConclusionAppendix IAppendix II Appendix III

679101011121212131314151516161617171718192021


Scope

Modern medicine strongly depends on the use of medical devices for purpos-es of both care and cure. In contrast to pharmaceutical products, their primary mode of action is not pharmacological, immunological or metabolic. Medical devices range from large capital hospital fixed equipment, through high-technology implants, surgical and monitoring equipment, to more familiar products such as wheelchairs, sticking plasters, syringes, incontinence aids and spectacles. The product category of medical devices falls apart in three classes: medical devices (making up about 80% of the total including medical software), in vitro diagnostics (IVDs) and active implantable medical devices (AIMDs). Examples of IVD devices include reactors, instruments or other devices used for examining sample material from the human body, including excreted material, for providing information to ensure a correct patient diag-nosis. An AIMD is any medical device which is totally or partially introduced (surgically or medically) into the human body and which is intended to remain after the procedure. Common examples are pacemakers, defibrillators, coch-lear implants, insulin pumps and neurostimulators.

Market introduction of medical devices is preceded by certification and reg-istration, which are accomplished in compliance with national and interna-tional regulations. Certification by placing the CE-mark is a requirement for selling most medical products and equipment in the EU. For certification, each country has appointed one or more authorities to perform the certification procedure. In Europe, these authorities are named notified bodies (NBs) and operate independently of each other. The objective of NBs is to assess the performance of medical devices in terms of performance and safety, while evidence of effectiveness is not required at the stage of certification.


In Europe, registration of medical devices is subject to harmonised European directives established in the 1990s. The core legal framework consists of three directives: Directive 90/385/EEC regarding active implantable medical devices (AIMDD 90/385/EC), Directive 93/42/EEC regarding medical devices (MDD 93/42/EC) and the Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD 98/79/EC).

The directives aim at ensuring a high level of protection of human health and safety and proper functioning. The directives define safety and performance requirements for medical devices sold in the EU and apply to both products and manufacturers. They have been supplemented over time by several modi-fying and implementing directives.

European legislation on medical devices

EU Directive Device category Class/list NB involvement Dutch registration European registration

MDD 93/42/EC

Medical device

class I X

NOTIS system

(CIBG/Farmatec)

Eudamed

class Is √ to assess “sterile” or

“measure” aspectIGZ via NB

class Im

class IIa

√ IGZ via NBclass IIb

class III

IVDD 98/79/EC

High-risk IVD

list A

√ IGZ via NBlist B

self-tests

Low-risk IVD other XNOTIS system

(CIBG/Farmatec)

AIMDD 90/385/EC

AIMD n/a √ IGZ via NB

Table 1 – Overview of medical devices directives, categories, classes and lists


Figure 1 – General order of activities in compliance with European regulations

Concurrently MEDDEVs have been developed, which are documents describ-ing the guidelines relating to the three EU directives for medical devices (Appendix A for an overview). The guidelines aim at promoting a common approach by manufacturers and NBs involved in the conformity assessment procedures. The MEDDEV guidelines are not legally binding. It is recognised that, e.g. as a result of scientific developments, an alternative approach may be possible or appropriate to comply with the legal requirements. The latest revisions in MEDDEV documents are listed in Appendix B, to provide an over-view of lively areas with respect to regulations.

The classes of medical devices that require involvement of a NB are specified in Table 1. Whether the involvement of a NB is necessary or not, the manu-facturer must draw up the Declaration of Conformity (DoC) to declare his sole responsibility for the conformity to the relevant Directive. The DoC is a proof of compliance with EC regulations to the involved to the authorities and customs and must be delivered with each product sold or with each batch of identical products sold to the same end user.

In addition to transnational regulations, national regulations apply to medical devices which may differ per country. In The Netherlands, products under the Medical Devices Directives are subjected to the “Wet op de medische hulp-middelen” (WMH; art. 2 t/m 5, 7 en 8), the “Besluit medische hulpmiddelen” (BMH), the “Besluit in-vitro diagnostica” (BID), the “Besluit actieve implan-taten” (BAI) and the “Regeling classificatie medische hulpmiddelen” regula-tions.

Definition directive

AIMDD 90/385/EC MDD 93/42/EC MDD 98/79/EC

MD class Is/m,II, III √ IVD list A/B √ IVD self-testing √ AIMD √ Find NB via Nando

QMS Declaration of Conformity (DoC)

STED layoutAnnexes

Verify requirements

Involvement Notified Body

Check conformity

Technical documentation CE marketing


The MDD 93/42/EC defines products into different classes, based on risk and intended use, which determine the relevant conformity assessment procedure. For products clas-sified with medium to high degree of risk (class Is, Im, IIa, IIb and III) the MDD requires a conformity assessment procedure involving a notified body (Table 1). The stringency of the conformity assessment procedures depends on the class of the medical device. For each class, the manufacturer has the choice between two or more conformity assess-ment procedures (Table 2, Appendix C). Each of the conformity assessment procedures consists of the application of one or more Annexes out of Annexes II to VII of the MDD. The clinical evaluation must be part of the documents which the manufacturer submits to the NB for assessment.

Annex II section 4 applies only to class III MDs and this section is similar to Annex III with the difference that in-house test results obtained by the manufacturer under full qual-ity management system may be used as the basis of certification. The manufacturer may thus choose the ISO 13485 standard in combination with the respective guidance standard as the basis of the QMS or use an equivalent quality system suitable to fulfil the requirements of the MDD (see Paragraph on CE certification).

Additionally in Annex VIII, MDs are described that are excluded from CE certification. These comprise:

• MDs intended for clinical investigations (the requirements here include METc approval, device description, researcher and patient identification, IGZ notification);

• custom-made MDs;• home-made/home-use MDs.

Medical devices

Conformity assessment procedure Medical device class

Annex IIs

SterileIm

MeasureIIa IIb III

II (+ section 4) √

II (- section 4) √ √ √ √

III √ √

IV √ √ √ √ √

V √ √ √ √ √

VI √ √ √ √

VII √ √ √ √

Table 2 – An overview of the conformity assessment procedures suitable for specific classes of MDs.


Some examples per class of medical device are provided here (for an exact overview of classification guidelines please refer to this document by the EU):

• class I: urine collection bottles, non-sterile dressings, eye occlusion plasters, stethoscopes, handheld mirrors in dentistry, examination gloves;

• class IIa: tubes for infusion pump, pressure indicator, syringes for infusion pumps, containers or bags for temporary storage and transport of organs, fridges for blood storage, dressings that control the level of moisture of the wound, adhesives for topical use, stents, tracheal tubes;

• class IIb: haemodialysers, gradients medium for sperm separation, dressings for chronic extensive ulcerated wounds or severe decubitis wounds;

• class III: prosthetic or biological heart valves, drug delivery systems, breast implants, hip joint replacements systems.

Medical softwareThe amount of innovative medical software is rapidly increasing, however, their fit with regulative standards is still in development. Standalone software that meets the definition of a medical device shall be considered as an active medical device falling under the MDD. Software which drives a medical device or influences the use of a device falls automatically into the same class of medical device. Standalone software qualified as in vitro diagnos-tic medical device should be regulated according to the IVDD (see Figure 2 for a decision diagram for classification of standalone software). Some examples of medical software classified as medical device Class IIa or IIb are:

• IIa - registration of PET datasets on CT datasets for follow-up tumour treatment, software for the presentation of the heart rate or other physiological parameters during routine checkups;

• IIb - radiotherapy planning system used to calculate the dose of ionising radiation to be administered to the patient, software for the presentation of the heart rate or other physiological parameters for intensive care monitoring, insulin dosage planning standalone software.

While IVDs are a type of medical device, in practice they are fundamentally different from other medical devices: 1) no direct benefit of IVD to the patient but indirect based on further actions by the patient or healthcare professionals and 2) IVDs never pose a risk to a patient or a population directly. For these reasons, the EU legislates separately for IVDs and medical devices. The first step is to verify whether your product falls within the definition of an IVD in accordance with the IVDD 98/79/EC. MEDDEVs 2.1/6 and 2.14 pro-vides guidelines and decision diagrams for classifica-tion of a medical device or medical software as an IVD or as medical device. Next, the specific require-ments for CE marking, known as Essential Require-ments, are listed in Annex I of the IVDD. The involve-

ment of a NB is necessary for high-risk IVDs listed in Annex II of the IVDD subdivided into List A and List B. For all IVDs listed in List A or List B, the NB verifies the design of the medical device and its compliance with the Essential Requirements. Also, in most cases, the NB verifies the QMS of the manufacturer. If the IVD is not on the lists in Annex II, no involvement of the NB is necessary unless the medical device is designed for self-testing. Within IVDD 98/79/EC, manufacturers and authorised representatives can demonstrate compliance with the essential require-ments through harmonised standards which are mandated by the EC to support the Directive. Once the necessary steps have been successfully complet-ed, the CE marking must be affixed to the IVD.

In vitro diagnostic medical devices


Active and non-active medical devices are discriminated and contribute to correct clas-sification. An active medical device is by definition any medical device that relies for its functioning on a source of electrical energy or any source of power other than that di-rectly generated by the human body or gravity. The AIMDD specifically focuses on active implantable medical devices that are surgically or medically implanted into the human body. For all active implantable medical devices, the involvement of a NB is obligatory. The Essential Requirements for CE marking of AIMDs are listed in Annex 1 of the AIMDD. Compliance must be demonstrated by a clinical evaluation in accordance with Annex 7. Within the AIMDD, manufacturers and authorised representatives can demonstrate compliance with the essential requirements through harmonised standards which are mandated by the EC to support the Directive. Since classification of these medical prod-ucts is relatively straightforward, we will not go in further detail here.

Active implantable medical devices

Figure 2 – Decision diagram to guide classification of standalone software as medical device or IVD

Yes

MDD

Yes YesYes

Yes

No

No

Yes

No

No No

No

Yes

MDD

Stand alone software

5. Is it an accessory of

an IVD?

Not covered by MDD

2. Does it involve an expert system which provides

informationwithin the scope

of the IVD definition

4. Data only from medical

device?

3. Data obtained only

from IVD?

6. Is it an accessory of an

IVD

Combination of data coming from

IVD and MD

1. Covered by medical device

directives?

IVDD


The European market approval system consists of national authorities for separate certification and registration of medical products and is called a decentralised approval system. The decentralised procedure relies on the designated NB that regulates CE marking.

CE certification

The designated NBs of specific EU member state and countries having a regulatory agreement with the EU are registered in the EU New Approach Notified and Designated Organisations (Nando) information system. Dependent on the national regulation for the specific MD category and class (to be found on the website of the national medi-cine authority; in The Netherlands this is the Inspectie voor de Gezondheidszorg (IGZ) supported by the CBG-MEB), these NBs can be approached for a decentralised approval procedure. The appointed NB for the healthcare and medical products in The Nether-lands is DEKRA Certification B.V.

The standards for a CE certificate vary per NB, but obtaining CE marking may require relatively little data:

• for devices that are substantially equivalent to an existing product, a comparative literature review may be sufficient;

• for certain low-risk class medical devices (Class I, no Is or Im), companies can certify the device themselves without the involvement of a NB.

• higher-risk devices almost always require human validation data, but (other than medicine trials) trials need not be randomised and often address safety but not efficacy.

A preliminary review of regulatory and clinical protocols by a NB is optional. The advantages are the early identification of requirements for CE certification and an overview of the steps that need to be taken to fulfil these requirements. Investment in a protocol review at an early stage likely shortens the duration of the official CE certification procedure.

Notified Bodies

Preliminary procedure


The procedure comprises the following actions:• initial agreement on the regulatory strategy towards product classification and

Primary Mode of Action (PMoA) claims; if a medical device contains a pharmacological, immunological or metabolic mode of action, then it has to be assessed by the CBG-MEB (Medicines Evaluation Board);

• agreement on the category and class definition of a medical device (highest risk part is leading); in case a manufacturer is in doubt whether a product is classified as MD class I or higher, a NB must be consulted since registration within NOTIS does not verify if a product is correctly classified as a class I MD;

• compliance with QMS requirements;• build-up of a technical file.

QMSThe requirements for approval of QMS are largely covered by the requirements to obtain an ISO 13485 certificate. This international standard (ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes) specifies require-ments that can be used by an organisation for the design and development, production, installation and servicing of medical devices and for the design, development and provi-sion of related services. It can also be used by internal and external parties, including certification bodies, to assess the organisation’s ability to meet customer and regula-tory requirements. Any activity that receives inputs and converts them to outputs can be considered as a process. For an organisation to function effectively, it has to identify and manage numerous linked processes.

The adoption of a QMS in accordance with ISO 13485 is not obliged, but involves a strategic decision with internal and external advantages for the product and the company. Compliance with this ISO standard has advantages for the product because it stimulates to meet planned results in your production, to warrant checkpoints such as risk analysis and clinical evaluation, to focus on process performance and effectiveness and to consider improvements. The design and implementation of an organisation’s quality management system is not uniform, but influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organisation. Moreover, ISO certification of your products demonstrates that your company

• intends to comply with legal regulations and requirements imposed by regulative authorities and the government;

• acknowledges the importance of quality and safety surveillance with regard to medical devices;

• advocates for a sustainable and future-oriented approach.

Together this provides added value for the reputation of your company and helps to attract new clients and potential business partners within and outside the EU.

CE certification procedure


Technical fileThe purpose of a CE technical dossier is to show compliance with the essential require-ments for one single product (family). In general it must be emphasised that a techni-cal file is seen as a controlled document that will need to be updated where relevant. It is the responsibility of the legal manufacturer to obtain the technical file and keep it updated, but the actual production activity may be outsourced; a copy present at the manufacturing site is very useful. The technical file is commonly based on a STED layout.

A Summary TEchnical Document (STED) is a harmonised format for submitting infor-mation for regulatory approval of new medical devices. The STED format was created by the Global Harmonization Task Force (GHTF) with the long-term goal to globally standardise regulatory submissions. The five GHTF members (Australia, the EU, Japan, Canada and the United States) have evaluated STED as a pilot program likely reducing inter-country differences in technical dossiers. A revised format of the STED layout for medical devices is expected in due time.

The core components of a technical file based on STED layout are:

General aspects of the device These aspects include the manufacturer, critical subcontractors, manufacturing site certifications and worldwide regulatory status of the product type.

Device description This description should include extended descriptions of all components and accessories of the device, their functional characteristics, technical perfor-mance specifications (e.g. accuracy, sensitivity, specificity, reliability) and other specifications (e.g. chemical, physical, electrical, mechanical, biological, sterility, stability, storage).

Essential principles and evidence of conformityList of standards per part of the system, Essential requirements

Risk managementThis includes a risk management plan for the lifetime of the product, risk analysis for the various components, the manufacturing process and the clinical use during the various phases of the lifetime of the product.

For risk management, several techniques can be used, e.g. Fault Tree Analysis (FTA; IEC 61025) and Failure Modes and Effects Analysis (FMEA; IEC60812) during the design, FMEA during production, Post Market Surveillance/Com-pliant/CAPA when the product is on the market. Risk analysis is preferably performed following the ISO 14971:2012 standard.

Summary of design verification/validationDesign assurance, safety of medical electrical devices, electromagnetic compatibility, software validation protocol, sterilization, packaging, shelf-life, biological safety, biocompatibility and clinical evidence.


Manufacturing informationDescription of manufacturing process for product and accessories indicating quality control (QC) operations

LabellingAll labels, product brochure, instruction for use, technical manual and maintenance.

An inventarisation step is advised prior to CE registration to determine the regulatory strategy. This can involve a review of drafted clinical or regulatory protocols and is an optional service provided by NBs such as DEKRA. The cost and duration of the certifica-tion procedure itself are dependent on the class and on the status of QMS and the tech-nical file. The minimum duration of a certification procedure with a NB is twelve weeks, but is typically much longer. The cost and duration of the certification procedure itself are dependent on the class (e.g. a class I MD and a class III MD can differ about fivefold). After that, yearly extension costs apply.

A CE mark expires after three years. Upon CE certification in the first year, two years of unannounced surveillance audits follow. As part of vigilance, the safety and intended use of the medical device is monitored after its introduction on the market post-mar-keting surveillance (PMS) and post-marketing clinical follow-up (PMCFU). In the fourth year, renewal of the CE mark can be applied for. The manufacturer or the authorised representative is requested to keep copies of the technical documentation at least 5 years, for IVDs and AIMDs at least 10 and 15 years, respectively, after the last product has been placed on the market.

Investment

Follow-up and extension


Registration

The Medical Device Directive dictates a European databank for medical devices, which is effective under the name Eudamed since May 2011. The aim of Eudamed is to strengthen market surveillance and transparency in the field of medical devices by providing competent authorities of European member states with fast access to infor-mation on manufacturers and authorised representatives, on devices and certificates and on vigilance and clinical investigation data. Eudamed also aims to contribute to a uniform application of the MDD, in particular in relation to registration requirements. Products registered with national authorities (CIBG/Farmatec in The Netherlands) can be retrieved in Eudamed.

Under the Dutch medical device legislation, four forms of notification are warranted by the designated authority:

• notification of new class I MDs and IVDs that will be marketed (CIBG/Farmatec via NOTIS registration system);

• notification of clinical studies on MDs and of effectiveness studies on MDs (IGZ);• notification of incidences or near-incidences with MDs and IVDs (IGZ);• notification of custom-made MDs (e.g. dentures, glass eyes).

More specific, notification of class I MD and IVDs within NOTIS is required for:• the MD or IVD itself which is marketed in The Netherlands;• Dutch manufacturers in case the MD or IVD is marketed in other member

states or the EU;• Dutch authorised representatives of a non-EU manufacturer of the MD or IVD.

Medical devices registered within NOTIS are automatically registered within Eudamed. Medical devices that are not registered via NOTIS will be registered by NBs with the IGZ and subsequently within Eudamed.

European Union

The Netherlands


In Europe, a centralised procedure and national pro-cedures for approval of medical products for clinical use co-exist. The EMA is in charge of approval of medicines via the centralised procedure, which is a single market approval that is valid in all EU countries and compulsory for specified medicines. However, medical devices are not subjected to the centralised procedure, but to a national procedure that differs per EU member state. Currently, medical devices that have been approved by the decentral-ised NBs of an EU member state only need to show adherence to quality standards and safety before being commercialised. Medical devices bearing a CE mark are considered of sufficiently proven perfor-mance and safety for application in clinical practice. There is a route available to companies for the authorisation of medical devices in several countries simultaneously. Hereby companies can apply for the simultaneous authorisation in more than one

EU country of a medical device that has not yet been authorised in any EU country.

Registration and market approval of medical devices in the US is under guidance of the FDA, like pharma-ceuticals, which applies a risk-based approval system for all categories of products. In practice, this implies that a solid base for effectiveness of the product is required as well. Another difference is that novel products in a certain category require a premarket approval (PMA) by the FDA, whereas subsequent comparable products require a 510(k) premarket notification by a less rigorous procedure. Low-risk class I and some class II medical devices do not require a 510(k); these medical devices are named “510(k) exempt”. However, the trend is that market introduction of these exempt classes become more and more controlled by new regulations.

Medical devices that are legally marketed in the US may be exported to anywhere in the world without prior FDA notification or approval. Devices that have not been approved or cleared in the US must follow the export provisions of the Federal Food, Drug and Cosmetic (FD&C) Act. Depending on which section of the FD&C Act a company is exporting under, it may need to request an export permit letter or export cer-tificate prepared by the FDA or it may need to submit a simple notification to the Federal Register.

Mission & vision Whereas notified bodies (NBs) are of-ficially independent of each other, col-laboration takes place between them on the level of policy making. Some of the most influential NBs worldwide now joined forces to define a policy an-ticipating on the latest developments in certification procedures. Together they establish a code of conduct (CoC) in order to apply on future certification of emergent technologies. The latest publications on policy and strategy as-pects defined in a CoC are available in a MEDDEV for the specific subject.Also within the EMA, a Committee for Advanced Therapies and Medical De-vices Notified Body (CAT-NB) collabo-ration group is raised to facilitate the implementation of regulative aspects relating to advanced-therapy medici-nal products (ATMPs) when combined with medical devices (MD). It is a tem-porary, specialised advisory group that overall identifies and promotes exam-ples of best practices by NBs operating on this specific cutting surface.

Foreign manufacturers must meet applicable US medical device regulations in order to import devices into the US even if the product is authorised for marketing in another country. These requirements in-clude registration of establishment, listing of devices, manufacturing in accordance with the quality system regulation, medical device reporting of adverse events and premarket notification 510(k) or premarket approval (PMA), if applicable. In addition, the foreign manufacturers must designate a US agent. As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection.

Registration and market approval in Europe versus US

Importing US products into Europe

Exporting EU products into the US


Conclusion

Europe is known worldwide as a leader in medical device innovation – the best and most advanced life-enhancing and life-saving devices in the world are developed in Europe. It is widely acknowledged that European manufacturers are heavily challenged during commercialisation of new medical devices and that the moment of market introduction is crucial in this highly competitive market. At the same time, safety, risk reduction and conformity to regulations are not to be moved past. Still, Europeans have access to the latest medical devices on average 3-5 years sooner than people in other parts of the world. This difference is owed to the relatively large number of medical device innovators and the decentralised approval system that efficiently reviews the safety and performance of new medical devices without causing unnecessary delay. Research has also shown that Europe’s system is just as safe as the centralised system used in other parts of the world such as the US. This renders Europe currently the most attractive market for introduction of medical devices. However, because of recent changes in EU regulations on MDs and IVDs it is unsure for how long still. In addition, it should be kept in mind that introduction of European devices towards the USA is an exhaustive procedure.


Overview of the available MEDDEV documents as guidelines for the MD, IVD and AIMD Directives

Appendix A

MEDDEV Document

Title ScopeMost recent revision

2.1 Scope, field of application, definition

Basic definitions and interface with other directives 2.1/6January 2012

2.2 Essential requirements Electromagnetic (EMC) assessment of MD, expiration of product quality (“use by” date)

2.2/4 January 2012

2.4 Classification of MD Definition of MD classes I, II, III, IVDs and AIMDs 2.4/1 rev. 9June 2010

2.5 Conformity assessment procedure

General rules, regulatory auditing of quality systems of medical device manufacturers and conformity assessment for particular groups of products

2.5/10 January 2012

2.7 Clinical investigation, clinical evaluation

Evaluation guidelines, notification of clinical investigation, reporting serious adverse events

2.7/4 December 2010

2.10 Notified bodies Designation and monitoring of NBs within the framework of the MDD

2.10/2 rev. 1 April 2001

2.12 Market surveillance Vigilance system, post-marketing clinical follow-up studies, Manufacturer Incident Report (MIR) form

2.12/1 rev. 8 January 2013

2.13 Transitional period A clarification on the provision in MDD 93/42/EEC (“The concepts of placing on the market and putting into service refer to each individual product”).

2.13 rev.1August 1998

2.14 IVD Borderline and classification issues, research-use only (RUO) products, instruction for use (IFU), registration form

2.14/1 rev. 1, 2.14/4 January 2012

2.15 Other guidances Committees/Working Groups contributing to the implementation of the MDD

2.15 rev. 3 December 2008


Overview of most recent revisions on MEDDEV documents (January 2012-January 2013)

vCJD = variant of Creutzfeldt-Jakob disease, IVF = In Vitro Fertilisation, ART = Assisted Reproduction Technologies

Appendix B

MEDDEV Document

Title Scope

January 2013

2.12/ 1 rev. 8

Medical Devices Vigilance System

Inclusion of IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual.

January 2012

2.1/6 Qualification and Classification of standalone software

Standalone software is a medical device when specifically intended to be used for one or more medical purposes. Standalone software for general purposes when used in a healthcare setting is not a medical device.

2.2/4 Conformity assessment of IVF and ART

This guideline aims at promoting a common approach of manufacturers of IVF/ART products of and NBs towards the requirements for the CE mark.

2.5/10 Guideline for Authorised Representatives

A summary of the role and the responsibilities of authorised representatives of manufacturers in terms of market surveillance.

2.12/2 rev. 2

Post Market Clinical Follow-up studies

A guide for manufacturers and NBs on how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil Post-Market Surveillance (PMS) obligations.

2.14/1 rev. 2

A guide for manufacturers and notified bodies on Borderline and Classification issues

The qualification of a product as an IVD or as a MD will have an impact on the essential requirements within the conformity assessment procedures, the appropriate technical specifications and the selection of a designated NB to conduct the conformity assessment procedure.

2.14/4 CE marking of blood based in vitro diagnostic medical devices for vCJD

This guideline defines the minimum desirable properties of a test for vCJD potentially suitable for blood screening. If other applications of the tests are proposed e.g. confirmatory, diagnostic, monitoring, the evaluation of the performance of these tests shall be specifically adapted to the intended use.


Overview of annexes II - VII of the MDD 93/42/EEC (specific for medical devices)

Appendix C

Annex Scope

II - EC Declaration of Conformity Most comprehensive procedure referring to a full quality system including the design history file (DHF) for new devices or changes of existing devices. This Annex allows continuous revisions of the technical file.

III - EC Type Examination Procedure for the product design which involves examination and third party testing of representative samples of the device and certification.

IV - EC Verification Procedure in which the NB examines and tests every individual device or devices on a statistical basis to assess homogeneity of batches.

V - EC Declaration of Conformity Procedure for the quality system of the manufacturer excluding the design phase of new devices but including all other aspects of conformity with the MDD.

VI - EC Declaration of Conformity Procedure for the quality system for manufacturers of devices whose relevant properties can be assessed in final inspection.

VII - EC Declaration of Conformity Procedure for the quality system for manufacturers of devices whose relevant properties can be assessed in final inspection.


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Certification and registration Medical devices on the European market - ttopstart spottlight

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Transcript of Certification and registration Medical devices on the European market - ttopstart spottlight