FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

2021-09-16T08:05:49+00:00September 16th, 2021|Categories: Clinical Trial, Compliance, Europe, FDA, Innovation, Regulatory|Tags: , , , , , , , , , , , , , |

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the EU. "The goal of the PSA

France: ANSM updates guidelines and forms for a scientific opinion for a medical device incorporating a medicinal substance

2021-07-21T10:58:22+00:00July 21st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , , |

The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, even if the medical device taken

MHRA announces combined review of clinical trials for medicinal products

2021-07-19T08:48:04+00:00July 19th, 2021|Categories: Clinical Trial, Europe, Regulatory, UK|Tags: , , , |

The Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline the review process for clinical trials of medicinal products concerning the changes brought by Brexit. As of January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will receive a combined review from MHRA

MDCG outlines rules on EUDAMED registration for custom made and legacy devices

2021-07-01T08:53:23+00:00July 1st, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

The European Commission’s Medical Device Coordination Group (MDCG) last week published a new guidance with Q&A on obligations and related rules for the registration in EUDAMED of actors not subject to registration requirements under the Art. 31 Medical Device Regulation (MDR) and Art. 28 In

Turkey: New MDR and IVDR are applicable

2021-06-18T08:35:56+00:00June 18th, 2021|Categories: Compliance, Europe, MDR, Regulatory|Tags: , , , , , |

The Medical Device Regulation (MDR) and the In vitro Diagnostic Medical Device Regulation (IVDR) were published in Turkish Official Gazette No. 31499 on 2 June 2021.  The Regulation, which is fully harmonized with European Union legislation, aims to improve the quality of medical devices and

Switzerland: New regulations applicable to medical devices as of 26 May 2021

2021-06-04T09:41:07+00:00May 27th, 2021|Categories: Clinical Trial, Compliance, Europe, Switzerland|Tags: , , , , |

Additional provisions have been adopted for the new Medical Device Regulation (MedDO) in Switzerland and enter into force on 26 May 2021. This action was taken to offset the negative consequences of the absence of the MRA update and ensure that the Swiss population is

Meditrial MDR DIVERSITY Germany Clinical Trials

2021-05-07T10:57:13+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: , , , , |

The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. The Authorities will expect that

Austria: medical device and IVD clinical trials submission process changes during transition to MDR

2021-04-22T10:58:02+00:00April 22nd, 2021|Categories: Clinical Trial, Europe, MDR|Tags: , , , , |

The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021. Meditrial manages several studies in Austria and has direct connections with investigators, hospitals and

EU: MDCG issued a guidance on standardization for medical devices

2021-04-19T08:47:50+00:00April 19th, 2021|Categories: Europe, MDR|Tags: , , , |

The European Commission Medical Device Coordination Group (MDCG) adopted a new standardization request for harmonized European standards in support of the MDR and IVDR after its initial standardization request was rejected last year. Contact Meditrial for a free consultation regarding your device! With international presence and

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