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Global Medical Device News

Europe | In-Vitro Diagnostic Devices, Medical Devices

BSI Becomes First Notified Body Designated under Europe's MDR

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The designation of BSI UK is in NANDO;
  • This does not cover BSI NL;
  • Other Notified Bodies are expected to follow soon.

The new Medical Devices Regulation (EU) 2017/745 is not an update of the current Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/382/EEC (AIMDD); it requires all devices to be certified again.

Except for Class I, self-certified devices, all devices require new certification by a Notified Body (NB). NBs can only certify...

Source | Ronald Boumans
Jan 22, 2019
United Kingdom | Medical Devices

Latest Brexit Agreement Voted Down by British Parliament

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Proposed agreement for leaving the EU voted down in UK Parliament
  • UK government survives vote of no confidence
  • New plan to be presented in Parliament on January 21, 2019
  • No-deal Brexit has again become a more realistic option
  • The EU will only allow for a delay if there are new facts justifying more time

On January 15th, 2019, the UK Parliament voted the Brexit agreement down by a record majority of 432 against 202. The Brexit agreement was the result of negotiations between the EU...

Source | Ronald Boumans
Jan 17, 2019
United States | Digital Health Products, Medical Devices

US FDA’s Pre-Cert Pilot for Medical Device Software Moving into Testing Phase

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has issued a new regulatory framework, working model and test plan for its Pre-Cert pilot program for Software as a Medical Device (SaMD).
  • The FDA Pre-Cert regulatory pathway would utilize FDA’s De Novo classification request framework for qualifying SaMD products.
  • FDA is accepting comments on these Pre-Cert updates through March 8, 2019.

The US Food and Drug Administration has issued major updates to its Software Precertification Program (Pre-Cert) pilot program for software and digital...

Source | Stewart Eisenhart
Jan 16, 2019
China | Medical Devices

China’s NMPA Launches Voluntary Device Master File Process

EMERGO BY UL SUMMARY OF KEY POINTS:

  • Chinese regulators are launching a record filing process for medical device master files (DMFs).
  • DMFs are used by NMPA reviewers and Chinese market applicants during device registrations.
  • The new process will be voluntary.

The Chinese National Medical Products Administration (NMPA) plans to establish a formal record filing process for Device Master Files for use in medical device registrations.

NMPA has published draft...

Source | Stewart Eisenhart
Jan 9, 2019
Europe | Medical Devices

Spotlight on PMCF: Requirements Ramping Up under European Medical Devices Regulation

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Medical Devices Regulation (MDR) will tie post-market clinical follow-up (PMCF) data more closely to post-market surveillance and clinical evaluation report requirements.
  • Medical device companies’ PMCF studies will have to include specific components identified in the MDR.
  • Approvals for PMCF studies will need to be obtained by Ethics Committees and, in some cases, Competent Authorities.

Requirements for manufacturers to provide clinical data obtained via post-market clinical follow-up (...

Source | Aleksandra Klimaszewski and Stewart Eisenhart
Jan 8, 2019
United Kingdom |

MHRA Guidance on a No-Deal Brexit

EMERGO BY UL SUMMARY OF KEY POINTS:

  • MHRA will take on responsibility for the UK market;
  • The CE Mark remains valid in the UK and no label changes are foreseen for now;
  • MDR and IVDR will be implemented in the UK in parallel with the EU
  • Non-UK manufacturers placing devices on the UK market need to appoint a UK Responsible Person, a role similar to that of the European Authorized Representative
  • The UK-based manufacturer or the UK Responsible Person must register the device in the UK.

On January 3rd, 2019, the...

Source | Ronald Boumans
Jan 7, 2019
United States | In-Vitro Diagnostic Devices, Medical Devices

US Government Shutdown Halts New FDA Medical Device Registration Activities

EMERGO BY UL SUMMARY OF KEY POINTS:

  • A partial US government shutdown has resulted in the suspension of FDA’s authority to collect medical device application user fees for the 2019 fiscal year.
  • Inability to collect user fees means FDA cannot accept any new medical device registration applications that require such fees until full US government funding resumes.
  • FDA will continue to carry out oversight functions related primarily to high-risk medical devices, imported product screenings and novel therapies.

A partial US government...

Source | Stewart Eisenhart
Jan 3, 2019
United States | Medical Devices

US FDA Scaling Back 30-Day Grace Period for GUDID Medical Device Data Corrections

EMERGO BY UL SUMMARY OF KEY POINTS:

  • FDA is ending an extended grace period for Global Unique Device Identification Database (GUDID) submission corrections in early 2019.
  • The GUDID grace period will be reduced from 30 calendar days currently to seven days.
  • The grace period allows medical device companies to edit or correct GUDID Device Identifier (DI) records following submission but before availability to the public.

Medical device regulators at the US Food and Drug Administration plans to wind down its temporary 30-day grace period in...

Source | Stewart Eisenhart
Jan 2, 2019
Europe | Medical Devices

Brexit Contingency Action Plan Issued by European Commission

EMERGO BY UL SUMMARY OF KEY POINTS:

  • The European Commission has published its emergency plan for Brexit.
  • The focus of this plan is to safeguard the interests of European citizens and UK citizens currently living in the EU27.
  • Plans are defined on a high level; there is nothing specific on medical devices.

The UK has voted in a referendum to leave the European Union (EU). The procedure, described in article 50 of the Treaty of the European Union, started on March 30, 2017 and should take two years at a maximum. With less than 100 days to...

Source | Ronald Boumans
Dec 20, 2018
United States | Combination Products, Medical Devices

US FDA Finalizes Guidance on Breakthrough Medical Device Pathway

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA has published final guidance on its Breakthrough Medical Device market pathway for novel devices and combination products.
  • The new program incorporates elements of prior FDA programs including the Expedited Access Pathway (EAP) and Priority Review program.
  • Devices that use novel and cutting-edge technologies to address life-threatening or permanently debilitating diseases may qualify for the new program.

The US Food and Drug Administration has finalized details of a new registration route for...

Source | Stewart Eisenhart
Dec 19, 2018