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TQMC has acquired wide Domain Knowledge and Experience. You can FREELY access it here and here

DISCLAIMER: This matter here is a guide only. For authentic and up-to-date information, please contact TQMC.

The DIRECTIVES and STANDARDS listed here may have been subsequently REVISED . You must refer to the CURRENT REVISION and AMENDMENTS if any.

Friday, April 16, 2010

CE MDD

Legislation

Current legislation

Medical Devices are regulated by three main Directives:

Active implantable medical devices

In vitro diagnostic medical devices

(Other) Medical devices

Original directive

Directive 90/385

Directive 98/79 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[347 KB]

Directive 93/42

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Amendment 1

Directive 93/42

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Regulation 1882/2003

Directive 98/79 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[347 KB]

Amendment 2

Directive 93/68

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)

Directive 2000/70

Amendment 3

Regulation 1882/2003 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[218 KB]

Directive 2001/104

Amendment 4

Directive 2007/47

Regulation 1882/2003 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[218 KB]

Amendment 5

Directive 2007/47 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[185 KB]

Latest consolidated version

11.10.2007 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[158 KB] including amend ment No. 4

20.11.2003 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[188 KB] including amend ment No. 1

11.10.2007 pdf

български (bg) czech (cs) dansk (da) Deutsch (de) eesti (et) ελληνικά (el) español (es) Français (fr) Gaeilge (ga) italiano (it) latviešu (lv) lietuvių (lt) magyar (hu) Malti (mt) Nederlands (nl) polski (pl) português (pt) română (ro) slovenčina (sk) slovenščina (sl) suomi (fi) svenska (sv)
[265 KB] including amend ment No. 5

Latest but one consolidated version

20.11.2003 including amend ment No. 3

20.11.2003 including amend ment No. 4

You can find more detailed information about the medical devices legal framework on these following pages:




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