Medical Devices Directive (MDD) 93/42/EEC – Explained
Information | Understanding | Best Practice.In the Medical Device Directive M.D.D. 93/42/EEC there are defined articles and annex’s which detail the requirements for compliance within the European Union and European Economic Area. In total there are 23 Articles and 12 Annex’s. In order to place a Medical Device onto the European Union market, a manufacturer (or Authorized agent) must determine the medical device product Class. Once classified the manufacturer will need to ensure that the product meets the Essential Requirements of the MDD Directive. The manufacturer will outline in a Technical File how they have ensured compliance with the Essential Requirements. Depending on the Class of device, a conformity assessment route will be required in order to obtain or declare certification.
Below are detailed the Articles, Annex’s, possible Conformity Assessment Routes, Essential Requirements and Technical File details. In addition, follow-on amendments to the 93/42/EEC Directive are listed, plus reference Harmonised Standards relevant to the MDD.
Summary of new requirements under the Medical Device Regulations MDR 2017 745 >>>
Medical Devices Directive 93/42/EEC Articles:
Article 1 Definitions and Scope of the MDD Directive >>>
Article 2 Placing on the market and putting into service >>>
Article 3 Essential requirements >>>
Article 4 Free movement, devices intended for special purposes >>>
Article 5 Reference to standards >>>
Articles 6 & 7 Committee on Standards and Technical Regulations >>>
Article 8 Safeguard clause >>>
Article 9 Classification >>>
Article 10 Information on incidents occurring following placing of devices on the market >>>
Article 11 Conformity assessment procedures >>>
Article 12 Particular procedure for systems and procedure packs and procedure for sterilisation >>>
Article 13 Decisions with regard to classification and derogation clause >>>
Article 14 Registration of persons responsible for placing devices on the market >>>
Article 15 Clinical investigation >>>
Article 16 Notified bodies >>>
Article 17 CE Marking >>>
Article 18 Wrongly affixed CE Marking >>>
Article 19 Decision in respect of refusal or restriction >>>
Article 20 Confidentiality >>>
Article 21 Repeal and amendment of Directives >>>
Article 22 Implementation, transitional provisions >>>
Article 23 Statement that the MDD is applicable to Member states of the European Union.
Medical Devices Directive Annex’s:Annex I Essential Requirements >>>
Note: Annex II through to Annex VII outline the conformity assessment routes:
Annex II – EC Declaration of conformity (Full quality assurance system) >>>
Annex III – EC Type-examination >>>
Annex IV – EC Verification >>>
Annex V – EC Declaration of conformity (Production quality assurance) >>>
Annex VI – EC Declaration of conformity (Product quality assurance) >>>
Annex VII – EC Declaration of conformity >>>
Annex VIII Devices for special purpose >>>
Annex IX Classification Rules >>>
Annex X Clinical Investigations >>>
Annex XI Notified Bodies >>>
Annex XII CE Marking >>>
Conformity Assessment routes:Within the above, the Annex’s deal with different potential conformity assessment routes:
For Annex II: The manufacturer must have a Quality System audited by the Notified Body for Design, Manufacture and Final Inspection. Under “Design” the manufacturer will need a design dossier, documents to support design & manufacture and will need to implement a surveillance process.
For Annex III: An approved Notified Body certifies that a representative sample fulfils the directive in terms of product Design, Manufacture and Performance. The Essential Requirements must be met.
For Annex IV: Every product must be examined individually.
For Annex V: The Quality System must be approved for the Manufacture of the product in addition to EC type examination.
For Annex VI: The Quality System must be approved for the Final Inspection of the product in addition to EC type examination
For Annex VII: The manufacturer needs to establish Technical Documentation, PMA, Corrective Action, Declaration of Conformity.
Medical Device Classification and potential assessment routes:
Possible assessment routes relevant to product class are as follows:
Class I: Annex VII + Annex V
Class II a: Annex II or Annex VII + V or Annex VII + VI or Annex VII + IV
Class II b: Annex II or Annex III + V or Annex III + VI or Annex III + IV
Class III: Annex II or Annex III + V or Annex III + IV
Regardless of which ever assessment route is chosen, the manufacturer is required to ensure conformity with the Essential Requirements.
Medical Devices Directive Essential Requirements (ER’s)
There are a total of 14 Essential Requirement’s, divided into:
6 General Requirements, and
8 Requirements regarding
Design & Construction
Chemical, Physical & Biological Properties
Infection & Microbial Contamination
Construction & Environmental Properties
Devices with a Measuring Function
Protection against Radiation
Requirements for Medical Devices connected to or equipped with an Energy Source
Information supplied by a Manufacturer
Clinical Data must be obtained through Annex X.
Essential Requirements: General Requirements expectations.
1. Devices must be designed and manufactured in such a way that when used under the conditions and for the purposes intended, they will not compromise the clinical conditions or safety of the patients.
2. Safety principles, taking account of state of the art.
3. Benefits must outweigh the risks.
Device Classification.Under the MDD, medical devices are classified into 4 Categories
Class I – Low Risk
Class IIa – Medium Risk
Class IIb – Medium Risk
Class III – High Risk
For full detailed reference Annex IX >>>
CE Technical FilesAll classes of product to be CE marked must have a Technical File. The Technical File must establish and demonstrate conformity to the Essential Requirements
Part A (Summary) normally contains information such as the following:
General Information, Product Information, Manufacturing methods, Risk Analysis, Declaration Of Conformity, Labeling, Clinical Data, Essential Requirement Checklist
Part B (Supporting Documentation) would often contain information such as:
Validations, Reports, Design specifications, Labelling
Harmonised standards related to the Medical Devices Directive:
Medical Devices Directive 93/42/EEC – Legislation
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 93/42/EEC||1993||1994||OJ L 169 of 12.7.1993|
|Amending act(s)||Entry into force||Deadline for transposition in the Member States||Official Journal|
|Directive 98/79/EC||1998||1999||OJ L 331 of 7.12.1998|
|Directive 2000/70/EC||2000||2001||OJ L 313 of 13.12.2000|
|Directive 2001/104/EC||2002||2001||OJ L 6 of 10.1.2002|
|Regulation (EC) No 1882/2003||2003||–||OJ L 284 of 31.10.2003|
|Directive 2007/47/EC||2007||2007||OJ L 247 of 21.9.2007|
- Validation. Classification. Regulation. Requirements. Current best practices.
- FDA cGMP’s. EU MDR’s / MDD’s.
- FDA Medical Device Regulation.
- FDA Medical Device Classification.
- EU Medical Device Regulation and Classification (per MDD’s).
- European Medical Device Regulations (MDR’s).
- Current Good Manufacturing Practices. QSR’s. General requirements of the QSR’s.
- Quality System requirements to maintain compliant Validations.
- Medical Device Process Validation. IQ. OQ. PQ’s.
- 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 | Understanding | Best Practice >>>