April 20, 2021 Uncategorized

EUROPE

1. Commission Implementing Decision regarding Harmonised Standards

  • on biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products and clinical investigation of medical devices for human subjects
  • on medical vehicles and their equipment, anaesthetic and respiratory equipment, biological evaluation of medical devices, packaging for terminally sterilised medical devices, sterilisation of health care products, clinical investigation of medical devices for human subjects, non-active surgical implants, medical devices utilising animal tissues and their derivatives, electro acoustics and medical electrical equipment

2. On the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)

This Directive lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.

Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials

– Lead (0,1 %)
– Mercury (0,1 %)
– Cadmium (0,01 %)
– Hexavalent chromium (0,1 %)
– Polybrominated biphenyls (PBB) (0,1 %)
– Polybrominated diphenyl ethers (PBDE) (0,1 %)
– Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)
– Butyl benzyl phthalate (BBP) (0,1 %)
– Dibutyl phthalate (DBP) (0,1 %)
– Diisobutyl phthalate (DIBP) (0,1 %)

The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

3. MDR/IVDR: Commission updates on implementation, notified body designation

The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

Based on the pipeline of notified bodies undergoing assessment, there are eight more notified bodies for devices and one on the IVD side that that have reached the final stages of the designation process. Even more are in the middle stages of review, though it could take upward of a year for the notified bodies in those stages to receive designations.

Much of the Commission’s remaining to-do list for MDR and IVDR relate to the establishment of common specifications for devices and high-risk IVDs, Eudamed and EU reference laboratories (EURLs) for IVDs.

Accord to the rolling plan, common specifications for devices without a medical purpose listed in MDR Annex XVI are expected in Q3 2021 and common specifications for class D IVDs are expected in Q2 or Q3 of this year.

With Eudamed’s date of application now pushed back to May 2022, the Commission now expects to issue an implementing act defining the arrangements necessary for the database’s maintenance and support in Q2 2021.

Three actions related to EURLs have been pushed back, with an implementing act on the designation of such laboratories now expected some time between Q3 2021 and Q1 2022. The establishment of rules to facilitate the fulfillment of tasks by EURLs and establishing the fees they may charge for services are now expected in Q2 2021.

The Commission gave an update on its MDR/IVDR standardization request after the EU standardization organizations CEN and Cenelec rejected its previous request last year. The Commission says its new draft implementing decision was approved by the Committee on Standards last month and that it will adopt the implementing decision and send it to CEN and Cenelec within the next month. If the request is accepted, the Commission says that implementing decisions with the lists of references of harmonized standards will be published periodically throughout the remainder of 2021.

4. MDCG offers guidance on Class D tests during IVDR transition

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). The establishment of EURLs for a range of class D devices has been identified as an important priority by the Medical Device Coordination Group. The European Commission is preparing the implementing acts on tasks and criteria of the EURLs and fees they may levy, referred to in Article 100(8) of the IVDR, as well as the first call for applications to be submitted by the Member States. This document provides indications for how to apply the IVDR provisions related to expert panels and EURLs during the transition period, i.e. before 26 May 2022.

5. Fimea named another new notified body in Finland in accordance with the Medical Devices Ordinance (MDR)

Fimea has designated Eurofins Expert Services Oy as a notified body in accordance with the Medical Devices Ordinance. The designation was published on the European Commission’s website on 7.4.2021.
The designation is subject to a thorough evaluation of the application, extensive study, joint evaluation by the EU authorities and final approval by the MDCG, composed of the Commission and other Member States.

Fimea monitors the designated notified bodies located in Finland and also participates extensively in the joint assessment work of the European authorities.

New Zealand (MEDSAFE)

6. Outcome of the consultation on the Plan to update the New Zealand Code of Good Manufacturing Practice PIC/S Guide PE009-8 to PE009-14

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving largely positive feedback to a consultation.

In February, Medsafe began gathering views on its plans to adopt the updated PIC/S Guide to GMP. The change would replace a GMP code from 2009 with a version adopted by PIC/S, the Pharmaceutical Inspection Co-operation Scheme, in 2018. Doing so will bring significant changes to how Medsafe approaches topics including cross-contamination and starting materials, according to the agency. Medsafe received feedback from five respondents. Four agreed with Medsafe’s proposed timing of the transition to the new rules, which would see the updated GMP code take effect on 3 May and give the industry until 3 November to fully adapt to the revised rules. The fifth respondent called for more time to implement the updated code.

Over the past two years, Medsafe has made manufacturers aware of its intention to adopt the new rules, the agency said, and during audits has encouraged companies to review the old code against the updated PIC/S Guide to GMP. Other regulatory agencies, notably Australia’s Therapeutic Goods Administration (TGA), have already switched to the updated guide.

The overall feedback to the consultation was “generally positive,” Medsafe said. One respondent asked for additional guidance on how to interpret the requirements for GMP manufacture of aseptically compounded medicines under a “Licensed to Manufacture.” Medsafe also fielded requests for further information on “some specific clauses which affect individual responders.” The agency will contact respondents by phone or email to discuss their requests.

CHINA (NMPA)

7. Notice on the solicitation of relevant manufacturer information for the “Guiding Principles for the Registration and Technical Review of the Performance Evaluation of Human Immunodeficiency Virus Antigen and Antibody Detection Reagents

In order to guide the registration applicants for the registration and application of human immunodeficiency virus antigen and antibody detection reagents, and to further do the relevant technical review work, our center has now launched the “Human Immunodeficiency Virus Antigen and Antibody Detection Reagent Performance Evaluation Research Registration Technology Review the preparation of the Guiding Principles, and hope that manufacturers that are or are expected to apply for relevant product change registrations actively participate in our work. In order to facilitate contact and communication, NMRA are now soliciting information on relevant manufacturers from both domestic and foreign sources (including companies that have approved products and are or are expected to produce human immunodeficiency virus antigen antibody detection reagents).

Please fill in the relevant information clearly in the solicitation form (see attachment) and submit it to the center in electronic form before May 17, 2021.

8. Notice on the solicitation of production enterprise information of “Technical Guidelines for the Registration of Quality Control Products Fixed Value”

In order to guide the registration applicants to prepare and write the registration application materials for quality control product testing reagents, and to further improve the technical review of such reagents, our center has now launched the “Quality Control Product Value Registration Technical Guidelines 》, NMRA hope that the production enterprises that have the above-mentioned product research and development, production or registration declaration will actively participate in our work. In order to facilitate contact, NMRA are now collecting information on relevant manufacturing companies (including companies that have approved products or are expected to engage in the production of such reagents) from domestic and foreign sources.

Relevant enterprises are requested to fill in the information clearly in the solicitation form (see attachment for details) and submit it to our center in electronic version before May 17, 2021.