envelope  Contact us

phone1-301-495-0477

Understanding the Annexes for Medical DevicesThe path to market approval for a medical device in the EU is no simple decision for a manufacturer to make. The Medical Devices Directive, for almost every device class, gives manufacturers a choice as to which conformity assessment they would like to use.

For manufacturers, this presents a dilemma even if the manufacturer is familiar with the Directives, as how each device and quality management system answers to the conformity assessment requirements can be different. Choosing the best one is a careful consideration that manufacturers must make.

Why do manufacturers get a choice?

Article 11 of the MDD states all the choices that manufacturers have when it comes to their device’s conformity assessments, according to the class of the device.
This choice creates a conundrum for many manufacturers, especially ones that aren’t very familiar with the MDD.

One of the important things to remember is that manufacturers have a choice because each manufacturer is different from one another – what works well for one may not be feasible for another. This is also why some conformity assessments have different quality system requirements than others: the MDD contemplates both that a manufacturer may design their own device, and that the manufacturer may be the party that simply puts their name on the device just before shipping it and by doing so, take the responsibility as defined in Article 1.
Likewise, a manufacturer without a quality system may find that it’s better in the long run for them to build the quality system instead of seeking market approval for each batch individually. However, a manufacturer who truly will only have one batch, or one batch very occasionally, may find that this conformity assessment is a perfect fit.
It is important that the manufacturer assess their company’s and quality system’s structure before committing to a conformity assessment in order to ensure that it is indeed the right assessment. Simply because “everyone” goes with Annex II (full quality assurance system) doesn’t mean that it’s the best for everyone.

All conformity assessments require the manufacturer to have technical documentation about the device, which shows how the device conforms to the essential requirements. Each conformity assessment includes a technical documentation review for the notified body to perform. Even with a conforming quality management system, without conforming technical documentation, the notified body won’t issue EC certificates and the manufacturer won’t be allowed to place the CE marking on their device. This is the case even for lower-class devices (class I included) and conformity assessments that don’t have quality management system requirements.

Annex II: Full Quality Assurance System

This conformity assessment includes a review of the manufacturer’s entire quality management system that includes design, manufacturing, and final inspection. The full requirements for the contents of the quality management system are in Annex II.3. The device’s technical documentation is also reviewed, even if the device isn’t a class III device, according to Annex II.7. For the conformity assessments that LNE/G-MED performs, this means that the auditor will review the device’s technical documentation during the on-site audit to assess the device’s conformity to the Essential Requirements.

If a device is in class III and the manufacturer uses the conformity assessment in Annex II, the assessment will also include a design dossier review according to Annex II.4. During the design dossier assessment, the notified body reviews the device’s design dossier in its offices for its conformity to the Essential Requirements in Annex I.
This review goes more in-depth than the technical documentation reviews for lower-class devices, but it is proportional to the amount of information that a class III device would have in its design dossier to prove its conformity.

Annex III – EC Type Examination

In the EC Type Examination conformity assessment, the notified body verifies that a certain representative sample of the device conforms to the essential requirements. Type examinations look similar to design dossier assessments, in that the notified body performs an in-depth review of the device’s technical documentation off-site to ensure that the device meets the Essential Requirements. The minimum requirements for the technical documentation are included in Annex III.3.
The EC Type Examination conformity assessment is one that doesn’t include a quality management system component, but Annex III is usually combined with another annex that does include requirements for the manufacturer’s quality management system.

Annex IV – EC Verification

During EC Verification, the notified body carries out examinations and tests to verify the conformity of the product. The notified body either tests and assesses every product individually, according to Annex IV.5, or uses a statistical sampling method according to Annex IV.6 that ensures that they test and assess a large enough sample size for the device’s conformity.
The notified body certifies each product or each batch or lot, and the certificates they issue only pertain to that specific product or examined batch or lot.
This conformity assessment doesn’t have specific quality management system requirements, but it does include requirements for the manufacturer’s post-market surveillance system. In addition, the manufacturer must have some technical documentation on the devices and be able to show that they conform to the Essential Requirements.

Annex V – EC Declaration of Conformity:

Production Quality Assurance

Annex V has similar quality management system requirements to Annex II, but the main difference is that Annex II includes design requirements and Annex V does not. For Annex V conformity assessments, the manufacturer needs to have a quality management system for the manufacturing and final inspection for the devices, but there is no requirement that a design system is included. As a result, there may be no design history file to include in the manufacturer’s technical documentation.
However, even if there is no DHF, this conformity assessment includes a technical documentation review.
For some classes, Annex V is combined with Annex III.

Annex VI – Product Quality Assurance

As the annexes continue, they have fewer required procedures in a manufacturer’s quality management system. Annex VI, the last of the conformity assessments, requires a quality system for final inspection and testing, according to Annex VI.3. This means that a manufacturer wouldn’t need to have a quality management system that includes either design or manufacturing. However, this conformity assessment is usually combined with Annex III for class IIb devices, which could prove to be a lengthy review process for the device itself. In addition, this conformity assessment may not be feasible if the device requires a special manufacturing process. As a result, as with any conformity assessment, the manufacturer should truly consider the structure of their company and their quality system before choosing a conformity assessment procedure.

A conformity assessment procedure is the gate through which a medical device must pass in order to gain market access to the EU. As such, it’s important that manufacturers choose the right one for themselves and their devices. It’s also important that a manufacturer questions notified bodies regarding their methods of performing the conformity assessments. On the other hand, LNE/G-MED performs many technical documentation reviews on-site as part of its signature combined auditing services. For more information on how LNE/G-MED performs conformity assessments, contact us.

Annex Conformity Assessment Used with Classes… Quality System Requirements Requirements for Technical Documentation provided by the Manufacturer How LNE/G-MED Assesses Conformity
II Full Quality Assurance System Is/m, IIa, IIb, III

All points of the quality system, from design to final inspection, including:

*Quality Objectives and Business Organization

*Design monitoring and verification

*Manufacturing stage inspection and quality assurance techniques

*Final Inspection

Class III – Technical documentation related to the whole quality system including the design dossier as specified in Annex II.4

Class IIa and IIb – Technical documentation excludes design dossier as specified in Annex II.4 in accordance with Annex II.7

Class Im – Technical documentation related to the aspects of manufacture concerned with the metrological requirements only

Class Is – Technical documentation related to the aspects of manufacture concerned with securing and maintaining sterile conditions only

On-site QMS audit (requirements referred to in Annex II Section 3.2) and technical documentation review. For devices in Class III, design dossier reviewed at LNE/GMED.
III EC Type-Examination IIb, III None Technical documentation that allows an understanding of the design, manufacture, and performances. Documentation must contain points in Annex III.3. Technical documentation needed to assess the conformity of a representative sample of the “type” reviewed at LNE/G-MED.
IV EC Verification

Is/m, IIa, IIb, III

Products in sterile condition – Annex V.3 and V.4

None

Use Annex III for the technical

documentation requirements (except Classes Is/m and IIa - these use Annex VII). Documents defining the manufacturing process and provisions that are implemented that guarantee homogenous production. Products placed on the market in sterile condition – Technical documentation must show that provisions of Annex V.3 and V.4 are applied in addition for aspects of the manufacturing process designed to secure and maintain sterility.

LNE/G-MED must test each product or a representative sampling of each lot/batch, and certifies each individual product or lot/batch.
V EC Declaration of Conformity – Production Quality Assurance Is/m, IIa, IIb, III Quality system covers manufacturing and final inspection.

Use Annex III for the technical

documentation requirements (except Classes Is/m and IIa - these use Annex VII)

On-site QMS audit. For devices in Class IIa, on-site technical documentation review in addition to QMS audit.
VI EC Declaration of Conformity – Product Quality Assurance

Is/m, IIa, IIb

Products in sterile condition – Annex V.3 and V.4

Quality system covers final inspection, including:

*Quality Objectives and organizational structure

*Examinations and tests carried out after manufacture

*How the QMS is monitored

*Where and how final inspection takes place

Use Annex III for the technical

documentation requirements (except Classes Is/m and IIa - these use Annex VII)

Products placed on the market in sterile condition – TD must show that provisions of Annex V.3 and V.4 are applied in addition for aspects of the manufacturing process designed to secure and maintain sterility

On-site QMS audit. For devices in Class IIa, on-site technical documentation review in addition to QMS audit.
VII EC Declaration of Conformity I, Is/m, IIa Manufacturer must have a systematic procedure to collect post-market information about the devices in the field, including the provisions in Annex X. Technical documentation provided in accordance to requirements as specified in Annex VII.3

Class I – NB usually doesn't assess conformity.

Classes Is/m and IIa – On-site QMS audit and technical documentation review

 

LNE DOWNLOAD PDF Download this newsletter in pdf format here.

MDSAP Prepare the transition, worldwide market access

combo ISO 13485 9001

Questions?

We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

   1-301-495-0477

lne gmed arrow Submit a request

clientsWe're Hiring!

Due to rapid growth in North America, we're seeking Lead Auditors and Certification Project Managers responsible for medical device manufacturing clients.

ISO13485 Training

Transition to ISO 13485:2016
1 Day Course

Entrust a top training organization like LNE/G-MED to bring your employees up to speed!

The latest edition of ISO 13485 standard for the Medical Device Industry, ISO 13485:2016, was officially published February 25th, 2016. Medical Device manufactures have yet to understand the changes involved to undertake a smooth transition of their QMS and maintain compliance.

Training Content: Click here!

Register Today!

 Calendar Notified Body 06 06

Santa Clara, CA