BSI announced in January 2019 that BSI UK was the first EU Notified Body (NB) to achieve designation, under the Medicines and Healthcare products Regulatory Agency (MHRA) to the Medical Device Regulation (MDR) (EU 2017/745). We are now accepting applications under the MDR for our UK Notified Body (0086).
BSI is currently working in unprecedented circumstances with several on-going designation applications under MDR/IVDR; manufacturers requesting early renewals of Directives certificates; a positive stream of MDR applications; and a general increase in regulatory oversight of Notified Bodies by designating authorities. We support these changes to the regulatory environment, which are aimed at ensuring only safe devices reach the EU market. However, the result of all these changes is an increased strain on our resources. We are recruiting heavily and expect our team to grow to over 750 colleagues within Medical Devices by the end of 2019; an addition of over 200 new team members in 2019.
The transition to the MDR is a significant challenge to the medical device industry as a whole. The increased requirements on Notified Bodies mean the BSI team is under immense pressure to meet your requests. We are aiming to complete all submissions we have received within the timelines discussed with you. However, we are aware that you may be experiencing a reduction in our current service levels due to this increased demand on NB resources. We thank you for your patience under these trying circumstances while we are working rapidly to restore our service levels through improving our systems and internal workflows. Our priority remains to increase capacity as fast as we can in the current circumstances, while ensuring that regulatory compliance remains unaffected.
Please find below critical information for your business in relation to ISO 13485, certification under MDR and BSI Terms and Conditions of contract:
ISO 13485 policy update: Recertification via Strategic Review
Strategic Review certification cycles are an option where a client can have audits of equal duration every year with a strategic review on the third year rather than a full triennial recertification assessment. BSI will be removing the Recertification by Strategic Review from QMS certification cycles. This decision has been taken to facilitate global alignment as the current certification cycle format is incompatible with most healthcare schemes and accreditations (SCC, RVA, MDSAP, MDR, IVDR). This will not increase your audit durations over the certification cycle.
- Existing clients: Your certification cycle will be modified at the end of the current cycle (next recertification/renewal) and not mid-cycle.
- Combined scheme assessments: In the case of combined assessments (e.g. ISO13485 and ISO9001), you will need to move to a triennial recertification assessment cycle for all schemes which are assessed in a single combined cycle.
Your BSI Client Manager or Scheme Manager will discuss your options with you.
Products with a transition deadline of May 2020 for MDR certification
From our recent MDR survey, it has been drawn to our attention that some manufacturers may not be fully ready to meet the deadline for certain products under the MDR where the transition deadline is 26 May 2020 for continued market access.
Due to the increasing but constrained capacity within BSI Notified Body, we advise that you send your submissions in to us urgently. Such applications will be processed on a first-come-first-served basis and we will be less able to assure meeting the May 2020 deadline as it approaches. Applications after December 2019 are at significant risk of being unable to achieve certification by 26 May 2020.
Please review below for product specific information. For information about the various conformity assessment routes and requirements per risk class, refer to our new Conformity Assessment Guide for MDR.
1. Class I re-usable surgical instruments
You must obtain your CE certificate under Annex IX Chapters I and III or Annex XI – Part A (limited to re-use aspects as applicable) by 26 May 2020 for these devices.
Please submit your applications to BSI immediately if you have class Ir re-usable surgical instruments in your portfolio.
2. Products without an intended medical purpose, Annex XVI
The MDR states that the date of application of MDR for products under Annex XVI is the date of application of the Common Specifications. Further, the necessary common specifications shall be adopted by 26 May 2020. They shall apply as from six months after the date of their entry into force or from 26 May 2020, whichever is the latest.
We will currently only accept MDR applications from existing BSI CE clients who have devices with both medical and non-medical indications approved under the Directives. The application under MDR for such devices will be limited to only the medical indications initially.
We currently cannot accept and quote for the non-medical indications for such devices because the common specifications have not been published. Once the common specifications have been published, we can look to quote and extend the scope of the MDR certificates to include the non-medical indications for products under Annex XVI.
3. Class III Custom made implants
Article 52.8 of MDR requires that Custom made Class III implants undergo conformity assessment as per Annex IX Chapter I or Annex XI Part A and hence will need a CE certificate from a Notified Body by 26 May 2020 under MDR for continued market access.
Please submit your applications to BSI immediately.
4. Drug-device combination products under MDR Article 117, amendment to Directive 2001/83/EC – medicinal products for human use
Manufacturers of combination products regulated as medicinal products need to be aware of the changes brought about by the MDR. For drug-device combinations marketed as medicinal products where the combination is placed onto the market as an integral product, Notified Body involvement is required to confirm compliance of the device portion with applicable General Safety and Performance Requirements.
BSI will provide an opinion to the Medicines Competent Authority reviewing the product to confirm compliance. As of 26 May 2020, any pharmaceutical manufacturer would need to have an NB opinion in order to get a Marketing Authorisation Application (MAA) or change to existing MAA.
Please submit your applications to BSI immediately.
5. Reclassifications or up-classifications that currently have no CE certificate
There are several devices that currently do not require a CE certificate under the Directives, which will need certification under the MDR by the 26 May 2020 for continued market access. This may be due to up-classifications (e.g. some software that is currently Class I and are Class IIa or higher under MDR) or due to changes in the scope of the legislation (e.g. devices that contain non-viable derivatives of human tissues or cells, which are covered by MDR, but outside the scope of current directives).
If you have any such devices within your portfolio, please submit your applications to BSI immediately.
Who should I contact for further information?
Please contact your Commercial Account Manager to discuss any of these topics.
BSI appreciates your patience at this challenging time.
