EU MDR Module Updates – Supplier Help Center

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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