EU MDR Module Updates

Assent's EU Medical Device Regulation Module is regularly updated, reflecting changes made to the European Union Medical Device Regulation substance list. The substance list module updates, starting from December 2018, may be useful to Assent clients and their suppliers, as they navigate changes during the reporting cycle.

Substance additions during the Mar. 2022 – Dec. 2022 module update cycle:

Substance

CAS Number

EC Number

(+/-)-1,7,7-Trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one

36861-47-9

253-242-6

(1R,3E,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one

95342-41-9

 

(1R,3Z,4S)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one

852541-21-0

 

(1R,4S)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

741687-98-9

 

(1S,3E,4R)-1,7,7-trimethyl-3-(4- methylbenzylidene)bicyclo[2.2.1]heptan-2-one

852541-30-1

 

(1S,3Z,4R)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

852541-25-4

 

(3E)-1,7,7-trimethyl-3-(4-methylbenzylidene)bicyclo[2.2.1]heptan-2-one

1782069-81-1

 

1,2,4-triazole

288-88-0

206-022-9

1,4-dioxane

123-91-1

204-661-8

2,2-Dibromo-2-cyanoacetamide

10222-01-2

233-539-7

3-methylpyrazole

1453-58-3

215-925-7

4,4'-(1-methylpropylidene)bisphenol

77-40-7

201-025-1

4-Isododecylphenol

27459-10-5

 

4-Tert-butylphenol

98-54-4

202-679-0

6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol

119-47-1

204-327-1

Dimethomorph

110488-70-5

404-200-2

Mancozeb

8018-01-7

616-995-5

p-(1,1-Dimethylpropyl)phenol

80-46-6

201-280-9

Phenol, tetrapropylene-

57427-55-1

 

Pydiflumetofen

1228284-64-7

817-852-1

Tetrafluoroethylene

116-14-3

204-126-9

Tolpyralate

1101132-67-5

701-225-3

Vinyl cyclohexene dioxide (4-vinyl-1-cyclohexene diepoxide)

106-87-6

203-437-7

(±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC)

 

 

Chromium VI compounds
Note: This entry is not a new substance, but instead renames a previous EU MDR Declarable Substances List entry.

   

Phenol, alkylation products

   

 

Substance additions during the Sep. 2021 - Mar. 2022 module update cycle:

Substance

CAS Number

(1RS,2SR,5RS;1RS,2SR,5SR)-2-(4-chlorobenzyl)-5-isopropyl-1-(1H-1,2,4-triazol-1-ylmethyl)cyclopentanol 125225-28-7
2,2-Bis(bromomethyl)-1,3-propanediol 3296-90-0
2,5,7,10-Tetraoxa-6-silaundecane, 6-ethenyl-6-(2-methoxyethoxy)- 1067-53-4
2-butanone oxime 96-29-7
2-methoxyethyl acrylate 3121-61-7
Benzenepropanal, 4-(1,1-dimethylethyl)-.alpha.-methyl- 80-54-6
Bis(2-(2-methoxyethoxy)ethyl)ether 143-24-8
bis(α,α-dimethylbenzyl) peroxide 80-43-3
Dibenzo[a,l]pyrene 191-30-0
Diglycidyl resorcinol ether (DGRE) 101-90-6
Diisooctyl phthalate (DIOP) 27554-26-3
Dioctyltin dichloride; Stannane, dichlorodioctyl-, 3542-36-7
Dioctyltin dilaurate 3648-18-8
Flurochloridone 61213-25-0
N-Methylolacrylamide 924-42-5
Pymetrozine 123312-89-0
Pyrithione zinc 13463-41-7
Silicon carbide (SiC) 409-21-2
Sodium hydroxymethylamino acetate 70161-44-3
Stannane, dioctyl-, bis(coco acyloxy) derivs. 91648-39-4

 

Substance additions during the May 2020 – Sep. 2021 module update cycle:

Substance

CAS Number

Cobalt

7440-48-4

Chloromethylmercury

115-09-3

Dibenzo[a,i]pyrene

189-55-9

Dibenzo[a,h]pyrene

189-64-0

Ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.

97925-95-6

Quizalofop-P-tefuryl

200509-41-7

Diisohexyl phthalate

71850-09-4

Halosulfuron-methyl

100784-20-1

2-Methylimidazole

693-98-1

 

Substance additions during the Dec. 2018 – May 2020 module update cycle:

Substance

CAS Number

1-vinylimidazole

1072-63-5

2-benzyl-2-dimethylamino-4-morpholinobutyrophenone

119313-12-1

Acetaldehyde

75-07-0

butyl 4-hydroxybenzoate

94-26-8

Catechol

120-80-9

Cobalt(II) diacetate

71-48-7

Fluazifop-butyl (not stereo-specific)

69806-50-4

Gasoline, natural

8006-61-9

Octabromobiphenyl ether

32536-52-0

Propiconazole

60207-90-1

 

Article is current as of 2022-02-02.

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