Regulatory questions, answered.
Questions asked in RegAffairs AI and answered from official sources, with every claim cited to the document it came from.
Can a CE-marked medical device still be placed on the Great Britain market, until when, and what does MHRA registration require?
Yes. A CE-marked device can still be placed on the Great Britain market, but only until fixed transitional end dates, and it must be registered with the MHRA…
Under IVDR 2017/746, how is a companion diagnostic classified, and what transition deadline applies to legacy Class D devices under Regulation (EU) 2024/1860?
A companion diagnostic is a Class C device under the IVDR. Regulation (EU) 2024/1860 lets legacy Class D devices stay on the market until 31 December 2027…
Which EUDAMED modules are mandatory to use as of 2026, from what date, and what legal act triggered it?
Answer: Four EUDAMED modules have been mandatory since 28 May 2026: Actor registration, UDI/Device registration, Notified Bodies & Certificates, and Market…
Under EU MDR 2017/745, what classification rule applies to standalone software intended to inform decisions for diagnosis, and what class results? Compare with the FDA approach.
Under the EU MDR, standalone software intended to provide information used to take diagnostic or therapeutic decisions falls under Rule 11 of Annex VIII.
What is FDA product code DQY, what device class and regulation number is it, and list a few recent 510(k) clearances under it with K numbers.
FDA product code DQY is "Catheter, Percutaneous". It is a Class II device under 21 CFR 870.1250 (percutaneous catheter), cleared through the 510(k) pathway by…
What are the GMP requirements for drugs in Canada? Cover Part C Division 2 of the Food and Drug Regulations (C.02.001 to C.02.030), Health Canada's GMP guide GUI-0001, GMP inspections and ratings, and how Canadian GMP compares with US FDA cGMP (21 CFR 210/211).
Canadian drug GMP is set out in Part C, Division 2 of the Food and Drug Regulations, and it is enforced through the drug establishment licence (DEL) required…
Quel est le statut réglementaire du glyphosate (CAS 1071-83-6) en France en 2026 ? Couvrir le renouvellement de l'approbation UE (règlement d'exécution (UE) 2023/2660), les produits autorisés par l'ANSES et leurs restrictions d'usage (retraits, limitations de 2020), l'interdiction pour les particuliers et les espaces publics (loi Labbé), l'importation de produits achetés en Espagne, les sanctions, le crédit d'impôt pour sortie du glyphosate, et où trouver les doses autorisées (E-Phy).
En 2026, le glyphosate est approuvé dans l'UE jusqu'au 15 décembre 2033 et autorisé en France.
D.Lgs. 81/2008 (Testo unico sicurezza sul lavoro): com'è strutturato (titoli e allegati), quali sono gli obblighi del datore di lavoro (art. 18, 26, 28) e dei lavoratori (art. 20), quali sono le modifiche più recenti e dove si legge il testo aggiornato?
Il D.Lgs. 81/2008 ha 13 titoli (più il Titolo X-bis) e una serie di allegati numerati da I a LI.
As a food business operator in India, how do I choose an FSSAI-notified or NABL-accredited food testing lab, what parameters (nutrition, pesticide residues, microbiology, contaminants) must be tested under FSSAI rules, and what must a food test report contain?
Short answer: Use a lab on FSSAI's current notified list and check that its NABL (ISO/IEC 17025) accreditation is valid on your test date and covers your…
How do I use the EU Pesticides Database to look up a pesticide active substance's approval status, expiry date, MRLs and hazard data under Regulation (EC) 1107/2009 and Regulation (EC) 396/2005, and what French sources (E-Phy, OFB C3PO) add for products authorised in France?
Search the EU Pesticides Database by active-substance name. It returns three things: the approval record under Reg. 1107/2009 (status, approval date, expiry…
ヒヤリハットとは何ですか？定義、語源、ハインリッヒの法則（1:29:300）、インシデントや労働災害との違い、そして厚生労働省の職場のあんぜんサイトでのヒヤリ・ハット事例の位置づけと、事業場でのヒヤリハット活動の目的を、公的な出典つきで教えてください。
ヒヤリハットとは、仕事中に「もう少しでけがをするところだった」場面のことです。 厚生労働省「職場のあんぜんサイト」は、この「ヒヤっとした、あるいはハッとした」経験を取り上げて災害防止につなげるのがヒヤリハット活動だと説明しています。危険有害要因を見つける方法の1つとして効果的、とも位置づけています（安全衛生キーワード…
Scheda di dati di sicurezza (SDS): quali sono le 16 sezioni secondo l'allegato II del REACH come modificato dal regolamento (UE) 2020/878, chi è obbligato a fornirla, quando va aggiornata, in che lingua, e quando è obbligatoria per sostanze e miscele non classificate come pericolose?
Risposta breve: La SDS deve essere fornita da ogni fornitore della catena (fabbricante, importatore, utilizzatore a valle, distributore).
How do I search National Pollutant Release Inventory (NPRI) data for a specific facility's reported releases and transfers in Canada? Cover the NPRI online data search tool, the NPRI map, the open data downloads (bulk datasets on the Open Government Portal), what substances and years are covered, and the reporting thresholds that determine which facilities appear.
To look up one facility's releases and transfers in Canada, start with ECCC's NPRI data search.
Which phthalates are restricted or banned in cosmetics and fragrance products? Cover what phthalates are, which ones cosmetics have used (DBP, DEP, DEHP, BBP and others), their status under EU Cosmetics Regulation 1223/2009 Annex II and III, UK cosmetics rules, Washington State's Toxic-Free Cosmetics Act (RCW 70A.560) ortho-phthalate ban and dates, California rules, FDA's position in the US, and what 'phthalate-free' claims mean.
Phthalates are banned or restricted in cosmetics mainly by ingredient-by-ingredient listing.
What is the regulatory status of bisphenol A (BPA, CAS 80-05-7) in Canada? Cover the 2010 CEPA toxic designation, the polycarbonate baby bottle ban, BPA in food can linings and thermal paper receipts, and any current or proposed Canadian measures including the bisphenols group assessment.
I found no federal BPA restriction in Canada beyond the baby bottle ban.
¿Qué información obligatoria debe llevar la etiqueta de composición de un producto textil vendido en España según el Reglamento (UE) 1007/2011 y el Real Decreto 928/1987: nombres de fibra, porcentajes, tolerancias, idioma, productos exentos y mezclas?
Para un textil vendido en España, la composición la rige directamente el Reglamento (UE) 1007/2011.
What does REACH Article 33 require for SVHCs in articles, and how does the SCIP database notification work: who must notify, what is the 0.1% w/w threshold, what information goes into a SCIP notification and what must suppliers tell customers and consumers?
Approach. I read the current consolidated REACH Regulation (EUR-Lex consolidated version of 11 May 2026) for Articles 3, 7, 33 and 59.
How does the FSA Food Hygiene Rating Scheme score food businesses, what does each rating from 0 to 5 mean, and what does a 0 or 1 rating say about a business's compliance with food hygiene law in England, Wales and Northern Ireland?
Summary: Local authority food officers inspect a business and give it penalty points on three elements.
What is RIDDOR, what does it require employers to report under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013, and who does it apply to?
Approach. None of the regulatory collections I can search holds the text of RIDDOR 2013.
What is the regulatory status of hexabromocyclododecane (HBCDD) in the EU, the US and China?
Summary: HBCDD is effectively banned in the EU and China as a Stockholm Convention persistent organic pollutant (POP).