CE Check - Digital CE Marking

Clever Compliance 🔝⭐️

CE Check transforms itself into a global product compliance hub and rebrands as “Clever Compliance”.

CE Check: Transforming into Global Product Compliance Hub | CC Blog Established as a cloud-based CE marking software-as-a-service business, CE Check transforms itself into a global product compliance hub and rebrands as “Clever Compliance”.

Based in the ?
Manufacturing ?

Then you should read this article about the impact of on Medical Device Regulation in the UK 👉https://buff.ly/33syMHG😉

It summarises:
➡️ the current status of Brexit,
➡️ some of the key features of the current regulatory system for medical devices in the UK,
➡️ how a so-called “no-deal Brexit” could impact the sale of medical devices in the UK and EU,
➡️ options for cooperation between the UK and EU post-Brexit.

The Impact of Brexit on Medical Devices Regulation in the United Kingdom | JD Supra From disrupting the supply of medical devices to affecting how they are regulated and sold in the United Kingdom (UK), Brexit could carry significant...

PROBLEM: ’s 2D barcode requirement 😬
SOLUTION: marking 😏👉https://buff.ly/2r9hlxE ❗️

manufacturers can now use laser equipment to affix on small-part and orthopaedic devices.

How EU MDR will affect labeling on small medical devices | Medical Design and Outsourcing The new European Medical Device Regulation (EU MDR) Direct Part Marking (DPM) requirements challenge manufacturers of small-part and orthopedic devices to

Manufacturers of DRUG-DEVICE combination products should read this article 👉 https://buff.ly/32mpvQe ❕❗️

It focuses on:
➡️ what they need to know to achieve EU MDR compliance
➡️ the challenges they could face and how to overcome them.

The new EU MDR and its impact on drug device combination products This article discusses the key elements of the EU MDR pertaining to drug device combination products and how life science companies can organize themselves to ensure regulatory compliance is met. The author will work through what manufacturers of these types of devices need to know in order to achie...

The MDCG has published 28-page 📑 aimed at clarifying which types of will be regulated under the new and rules and how they ought to be classified and placed on the market.

Read more on the topic 👉https://buff.ly/34x27B6
Download the guidance 👉 https://buff.ly/2oJRdZx

Medical software makers get new guidance on MDR, IVDR The European Commission's Medical Device Coordination Group aims to clarify which software will be subject to the new regulations, and how those products should be classified and placed on the market.

IMPORTANT about ❗️

The launch of , the database which will be used to monitor the safety and performance of , is postponed until May 2022.

What does that mean for companies?
Will the 2-year delay extend the effective date of the MDR?

Find out here 👉 https://buff.ly/2BVVT1v 😉

It's official: EC confirms 2-year Eudamed delay The database will now go live in May 2022, giving the industry a reprieve and more time to complete projects. 

More than a dozen household have been from the shelves in the last three months❗️😲

Have a look at the 📃 of products 👉https://buff.ly/2nrmTlH ... It's literally overwhelming 😵

The dangerous household products recalled over the last three months There are quite a few on the list

For engineers, designers & managers❗️

A short review of the that the use of various ➕ a description of regulated substances and insight into why they may be restricted at the specific levels given in the standards and regulations 👉https://buff.ly/2AOXkOJ 👀

Hazardous Substance Restrictions …And Why They Are Restricted The use of chemical substances and their potential impacts on human health and the environment is a concern world-wide. This paper looks at substances and substance restrictions, why they are restr…

has released a guidance document to further explain Article 120(2) of the EU , which relates to certificates issued in accordance with the previous device directives.

Read more ➡️ https://buff.ly/31XkFJW
Access the document ➡️ https://buff.ly/2npykuh

MDR Guidance Addresses Transitional Provisions The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to further explain Article 120(2) of the EU Medical Devices Regulation (MDR), which says that certificates issued in accordance with the previous device directives will remain valid until 27 May 2024 at ...

related❗️

The European Commission has published that provide a step by step overview on how to assess the use of by conducting a benefit-risk assessment. Competent and will consider these Guidelines as the state of the art guidance concerning the use of phthalates in .

Read more here ➡️ https://buff.ly/2p153X9
Access the document ➡️ https://buff.ly/339LVoL

The European Commission has published Guidelines concerning the use of phthalates in medical devices | Focus on Regulation The European Commission's Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has published Guidelines concerning the use of

A new RAPS/KPMG highlights lack of for EU .

Only 27% of 230 makers expect to be in full compliance by May 2020 😲❕ What else did the survey reveal❓ ... Learn here 👉 https://buff.ly/2ppgHeH 👀

Just 27% of medical device makers expect to be in full compliance with EU standard by May deadline, study finds Fears raised that a lack of notified bodies to assess devices could result in product shortages and impact patient care.

Did you know about the initiated in May 2019 to amend some parts of the EU 😲❓❔

The corrigendum could potentially give some class I a 4-year transitional period before they are required to meet the new regulation's standards. The European Parliament has to pass it, and the vote is expected to happen this month.

Could the 'hard deadline' in May 2020 actually be avoided?
What are the chances?🤔

Find out here 👉 https://buff.ly/2mZHxt5 ❗️ ❕ ❗️

Class I device makers could get 4 extra years to comply with EU MDR The European Union's Medical Device Coordinating Group met with medical device stakeholders Monday in advance of an expected vote on a corrigendum to amend or modify some parts of major upcoming EU regulatory changes.