EU, ICH and Brexit Pharma Regulatory Update
June 19 was a tough day for the medical devices industry as the European standardization organizations rejected the standardization request by the European Commission, resulting in a delay of the harmonization process. Although a new request is planned for Q1 2021, there will probably not be any harmonized standards before the application date of regulation 2017/745.
For devices containing medicinal products or specific tissues, the Medical Device Coordination Group (MDCG) also published guidance on the consultation procedure for notified bodies. The document emphasizes that, independent of previous consultation procedures undergone under MDD/AIMDD, in the context of the MDR, a full consultation procedure must be conducted for the initial conformity assessment.
The third edition of ISO 14155:2020 on clinical investigations of medical devices for human subjects — Good Clinical Practice, as well as an MDCG template for clinical evaluation assessment, reports were published in July. The new edition provides further guidance on risk-based monitoring, quality management, study design, auditing and ethics committees, aligning its requirements with European and U.S. legislation. The MDCG 2020-13 template provides insight on what regulators expect notified bodies to check during clinical evaluation reviews.
On August 18, the MDCG issued a position paper on the use of the EUDAMED actor registration module and the single registration number (SRN) in the member states. The module and the ability to assign SRNs to economic operators are planned to be available by December 1, 2021. Although related requirements of regulation 2017/745 will not apply until May 26, 2022, MDCG asks member states to presume compliance with relevant national requirements if economic operators use the EUDAMED module. That way, the MDCG intends to avoid double registration requirements.
The MDCG published MDCG 2020-14 explaining the extent to which notified bodies can use MDSAP audit reports for MDR/IVDR surveillance audits. The guidance specifies that MDSAP audit reports can be used during surveillance audits to shift focus toward MDR/IVDR-specific topics; however, their use for initial certification audits and unannounced audits is prohibited. The guidance also states that the reports must be used in their entirety, including both positive and negative results.
The MDCG also published an FAQ about UDI requirements giving manufacturers a basic understanding of what is expected from them.
In terms of implementing regulation (EU) 2020/1207, on August 19, the European Commission published the first common specification, which specifies the documents required and actions that need to be taken in order to be allowed to reprocess single-use devices. It remains to the discretion of member states to completely prohibit reprocessing of single-use devices.
Brexit was the topic for September. The Medicines and Healthcare products Regulatory Agency (MHRA) published guidance on how medical devices will be regulated from January 1, 2021. The good news is that CE marking, and EU notified bodies will be recognized until June 30, 2023, but the UK will require a representative for manufacturers outside of the UK and an additional UKCA marking.
For manufacturers looking for notified body capacity, the Slovakian organization 3EC can be added to the list of possible partners. They got officially announced as the 17th notified body for the MDR.