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Media Centre >> News >> Medical Devices | Monthly bulletin | October 2019

Medical Devices | Monthly bulletin | October 2019

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Tuesday, October 1, 2019

Eurofins newsflash Medical Device

 

Europe

 

Final version of the SCHEER’s guidelines on phthalates in medical device

 

As already announced in our Eurofins News Flash April 2019 edition, in March 2019, the European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) opened a Public consultation on the Preliminary Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices.

 

In September 2019, SCHEER published the final version of these guidelines on the benefit-risk assessment of the presence of Phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties.

 

Click here for getting more information from European Commission’s website.

 

Some cosmetic and aesthetic products become Medical device

 

On 26th May 2020, the new regulations for medical devices will be fully applicable. At first we could think that it does not affect cosmetic products, but this is not the case. According to Annex XVI of the Medical Device Regulation (EU) 2017/745, the following cosmetic and aesthetic products have been redefined as medical devices:

 

  • Colored contact lenses
  • Liposuction equipment
  • Collagen implants
  • Tattoo removal equipment
  • Dermal fillers
  • Laser or Intense Pulsed Light (IPL) hair removal equipment
  • Skin resurfacing equipment

 

Affected manufactures, importers and distributors will have to meet CE mark certification requirements and maintain certification. The main points of medical device regulation compliance are:

 

  • CE Mark
  • CE certification
  • Classifying their products according to the regulation
  • Partnering with a designated Notified Body
  • Implementing a quality management system (EN ISO 13485:2016)
  • Companies with no physical presence in the EU will need to appoint a European Authorized Representative for in-country representation
  • Risk management plan
  • Post-market surveillance requirements
  • Clinical evaluation reporting

 

Preparations for BREXIT

 

The next 1st November 2019 will be the withdrawal date in which UK will leave the European Union.

 

On 4th September 2019, the European Commission published the report with reference COM/2019/394 final:

 

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN CENTRAL BANK, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE, THE COMMITTEE OF THE REGIONS AND THE EUROPEAN INVESTMENT BANK.

Finalising preparations for the withdrawal of the United Kingdom from the European Union on 1 November 2019.

 

UK Notified Bodies indicate that the transfer of medical devices certificates to EU Notified Bodies is well underway and, for the vast majority of devices, expected to be completed by 31 October 2019. But there are still manufacturers that have not taken all the measures needed for this transfer.

 

Remaining manufacturers and UK notified bodies are encouraged to ensure that the transfer of all certificates and the product label adaptations are completed by the withdrawal date so that manufacturers can continue to sell their products in the EU market.

 

Recent publications by European Commission

 

Below you will find a Decision recently published in the Official Journal of the European Union related to Medical Devices:

 

Date

Reference

Title

11-9-2019

C/2019/6414

Commission Implementing Decision (EU) 2019/1396 of 10 September 2019 laying down the rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the designation of expert panels in the field of medical devices

 

Regulatory proposals notified to WTO

 

Below a summary table with some recent notifications to World Trade Organization (non-exhaustive):

 

Notification number / Link

Title

G/TBT/N/EU/678

Draft Commission Delegated Directive amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases

 

Europe/International

 

Standards Updates

 

Below a summary table with some recent standards updates and upcoming dates of withdrawal (non-exhaustive):

 

(*) Date of withdrawal: latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn.

 

Reference

Title

Date of Withdrawal (*)

Supersedes

EN 14683:2019+AC:2019

Medical face masks - Requirements and test methods

2020-02-29

-

EN 80601-2-58:2015/A1:2019

Medical electrical equipment - Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

2022-08-23

-