Medical Device and UNI EN ISO 13485:2021

In September 2021, the EN ISO 13485:2016/A11 standard was published, which modifies the ISO 13485:2016 standard.
The modification consists in the introduction of two informative Annexes (ZA and ZB) which describe the relationships between the European standard (EN 13485) and Regulations (EU) 2017/745 and 2017/746, relating respectively to medical devices and medical devices in vitro diagnostics.
On 18.11.2021 UNI issued the UNI CEI EN ISO 13485:2021 standard, implementing the aforementioned changes and withdrawing the UNI CEI EN ISO 13485:2016 version.
The transitional period of coexistence of the two editions of the standard ended on 18 November 2023 and all the documentation of the company Quality System must refer to the new edition.
Verification of the update will be carried out during the first planned surveillance audit.

NEWS - BIO CHEM S.R.L.

Injectable fillers and the mdr regulation : the ministry of health’s clarifications on distributio
Biocides: national control plan for 2026 published
New regulation on detergents and surfactants published
Consulting in the field of ict system security
Echa has updated the list of suppliers of active substances or the list referred to in article 95 of
Harmonized standards for the sterilization of medical devices
Countdown to serialization
Legacy devices
Notification of production sites
Medical device and uni en iso 13485:2021
Estratto dagli highlights della riunione del comitato per la valutazione dei rischi in farmacovigila
Iso 14644-21 is released
Manual on borderline and classification in the community regulatory framework for medical devices (s
New allergens
Clinical trials: questions & answers document version 1.0 (05/2023)
Published the regulation 2023/707 amending the clp!
Aifa: istat rates update
Draft: who good manufacturing practices for excipients used in pharmaceutical 7 products
Self-certification and related contribution of 7%
Update on water in food supplements
Q13 continuous manufacturing of drug substances and drug products
Mdr - extension proposal
Update on nitrosamine impurities
Titanium dioxide, eu court annuls the regulation that considers it carcinogenic
Publishing service gazzetta ufficiale
Guidelines for the environmental labelling of packaging
Hazardous substances safety data sheets: new eu regulation 2020/878
Telematic management of applications and documents issued by the gmpmed office. new provisions start
Validity of authorizations as medical surgical aids for products intended for the disinfection of in
Medical devices, in the official gazette the legislative decrees for the adaptation of the national
Nsaids for systemic use: change request printed for use in pregnancy
Reports of suspected adverse reactions
Marketing of food supplements
Who publishes the new draft on chromatography
Ministry of health circular 4 march 2022 - ministerial indications for the placing on the market of
Self-certification and relative contribution of 7%
Medical device
Guidance on submission of marketing authorization/extension, ma variation and renewal applications,
Ema asks for checks on all the drugs on the market
59th afi symposium on 5-6-7 june at stand 83.
Aifa - increase in current rates
Method of submitting applications for marketing authorization, variations, renewals and asmf
Lists of scientific drug informers for the year 2018
Pay-back transaction agreements 2013-2015 (20/04/2018)
Brexit, ema publishes a guide to the industry in view of the uk exit from europe
Pharmaceutical excipients in the label, the guidelines reviewed by ce
Update: guideline on the excipients warnings to be included in the printed of homeopathic medicines
Lists of medical representatives medicines for the year 2016
Guideline on the excipients warnings to be included in the printed of homeopathic medicines (12/12/2
Aifa incoming single text changes "non-essential"
Medical devices, from spring 2017 they change the rules
COURSES

Our company offers courses from different content for different sectors.

REGULATIONS

Please login to the private area to download the pdf file of the regulations.

LOCATIONS

View all Bio Chem Srl headquarters in Naples, Rome, Milan


NEWSLETTER

Enable the E-Mail in the registration form to receive information on our initiatives.

SURVEY

From the following link will download the business service evaluation questionnaire regulators.

LINK PARTNER

The area dedicated to external links you will find all the links to our partners.