Information & Training. | Medical Devices.

Medical Device Regulation – 93 42 EEC

In Europe there are three Directives which determine the regulation of Medical Devices, namely the:

MDD – Medical Device Directive 93/42/EEC >>>
AIMD – Active Implantable Medical Devices Directive 90/385/EEC

IVD Directive – In Vitro Diagnostic Directive 98/79/EEC

In which countries do the directive apply?
The directives apply to all 27 countries currently members of the European Union (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK.) plus the following members of the European Economic Area (EEA), namely Iceland, Liechtenstein and Norway

Common within the above directives are standardised approaches to regulatory management, oversight and enforcement. The directives outline the regulations for Competent Authorities, Notified Bodies, manufacturers, distributors and European Union representatives.

Manufacturer.

Per the Medical Devices Directive a “manufacturer” is the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed onto the European market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.

Authorized Representative.

The MDD requires non-EU based manufacturers to appoint a designated person who has a registered place of business within the EU prior to the placement of Medical Device on the EU market.
The authorized representative will ensures that the product complies with the MDD. The authorized representative may hold part of the Medical Device Technical File to prove product conformity to the Essential Requirement’s. This information must be able to make available to the Regulatory Authorities upon request. The authorized representative must have their name and address on product labelling.
The authorized representative’s may be responsible (in place of manufacturer) for retaining and maintaining market surveillance documents and signing the Declaration of Conformity certificates.

Validation. Classification. Regulation. Requirements. Current best practices.
FDA cGMP’s. EU MDR’s / MDD’s.
FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
FDA Medical Device Classification. The FDA approach to Medical Device Classification.
EU Medical Device Regulation and Classification (per MDD’s).
^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
Quality System requirements to maintain compliant Validations.
Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
Medical Device Software Validation.
Medical Device Design Validation.
Electronic Signature, Electronic Records.
Life Cycle Approach to Validation.
Risk Identification. Documentation. DHR’s. DMR’s.
Etc. Etc. …
Information & Training presentation >>>

Competent Authority.

The Competent Authority maintains verification & testing documentation. The Competent Authority is the body who acts on behalf of a member state (governments) to designate Notified Bodies to carry out conformity assessment procedures.

They are responsible for handling applications for Clinical Investigations. For ensuring adverse incidents are reported within appropriate time-scales and evaluated. For ensuring the effective and efficient withdrawal of unsafe devices from the market. The Competent Authority will ensure full and consistent (with other European member states) implementation and application of the MDD into law within their national boundaries. They are responsible for ensuring that only those devices bearing the CE marking are allowed onto the market.
The Competent Authority are responsible for taking appropriate measures to withdrawn devices which compromise the safety and health of patients from the market or will prohibit or restrict their being placed on the market.

Information held by a Competent Authority may be shared between member states.

The Competent Authority can take action against a manufacturer for inappropriate use of the CE mark. Their remit is to ensure that all Medical Devices meet the Essential Requirement’s of the MDD’s, so as not to compromise safety of patients or users.

Notified Body.

The Notified Body is the certification organization which the Competent Authority has designated to carry out Conformity Assessment procedures. Examples of certification bodies are
e.g. KEMA, TUV, BSI

Kema Nederland B.V.

Country : Netherlands

Notified Body number : 2290

TÜV Rheinland LGA Products GmbH

Country : Germany

Notified Body number : 0197

BSI

Country : United Kingdom

Notified Body number : 0086

Each Notified Body has an identification number, e.g. 2290, 0197, 0086

The Competent Authority has the authorization to withdraw it’s member state’s Notified Body notification if it finds it no longer meets the criteria as specified in Annex IX (of the relevant directive, e.g. the Medical Device Directive).

The Notified Body cannot be the designer, manufacturer, supplier, installer or user of the medical device, for clear reasons of professional integrity and secrecy.

Medical Devices placed in to the European market must be CE marked.
The CE marking is a conformity marking consisting of the letters “CE”, and taking the form as shown. CE is an abbreviation for ‘Conformité Européenne’, French for ‘European Conformity’. Initially the term used was “EC Mark” but this was officially replaced by “CE Marking” in 1993 and is now used in all EU official documents. CE Marking on a product is a manufacturer’s declaration that the product complies with the essential requirements of the European Medical Device Directives”.

The CE mark is obligatory for placing a medical device onto the market.

How Medical Devices are regulated in Europe

Medical Devices compliance in Europe is indicated by the “CE” mark.

CE Technical Files.

All classes of product to be CE marked must have a “Technical File” and must establish and demonstrate conformity to the Essential Requirements which will contain information along the following lines:

Part A (Summary)
General Information, Product Information, Manufacturing methods, Risk Analysis, Declaration Of Conformity, Labelling, Clinical Data, Essential Requirement Checklist.

Part B (Supporting Documentation)
Validations, Reports, Design specifications.

Information & Training.

Medical Device:

- - Validation. Classification. Regulation. Requirements. Current best practices.
  - FDA cGMP’s. EU MDR’s / MDD’s.
  - FDA Medical Device Regulation. Outline of the FDA regulatory requirements.
  - FDA Medical Device Classification. The FDA approach to Medical Device Classification.
  - EU Medical Device Regulation and Classification (per MDD’s).
  - ^New European Medical Device Regulations (MDR’s). MDR Classification. MDR General Safety requirements.
  - Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
  - Quality System requirements to maintain compliant Validations.
  - Medical Device Process Validation. Validation requirements. Protocol development. IQ. OQ. PQ.
  - Medical Device Software Validation.
  - Medical Device Design Validation.
  - Electronic Signature, Electronic Records.
  - Life Cycle Approach to Validation.
  - Risk Identification. Documentation. DHR’s. DMR’s.
  - Etc. Etc. …
  - Information & Training presentation >>>